|
Select the Financial Report:
|
|
Select the Period:
|
|
What are Medtronic Plc's Business Segments?
Cardiac Rhythm Management
We are the worlds leading supplier of medical devices for cardiac rhythm management.
We pioneered the modern medical device industry by developing the first wearable
external cardiac pacemaker in 1957, and manufactured the first reliable long-term
implantable pacing system in 1960. Since then, we have been the worlds leading
producer of cardiac rhythm technology, and from these beginnings, a nearly $8'
billion industry has emerged. Today, our products and technologies treat a wide
variety of heart rhythm disorders.
Principal Products
We offer the broadest array of products in the industry for the diagnosis and
treatment of heart rhythm disorders and heart failure. Because many patients
exhibit multiple heart rhythm problems, we have developed implantable devices
that specifically address complex combinations of arrhythmias. In addition to
implantable devices, we also provide external defibrillators, electrophysiology
catheters, navigation systems and information systems for the management of
patients with our devices. Our CRM devices are currently implanted in nearly
1.8'million patients worldwide.
Implantable Cardiac Rhythm Devices.'Bradycardia is a very common condition,
with hundreds of thousands of patients diagnosed each year, and millions of
people worldwide suffering from its effects. The only known treatment for this
condition is a cardiac pacemaker, a battery-powered device implanted in the
chest that delivers electrical impulses to stimulate the heart to beat at an
appropriate rate. We are the worlds leading provider of pacing systems, offering
the broadest and most complete line of pacemakers, leads and related accessories.
Our EnPulse' pacemaker, the worlds first completely automatic pacemaker, was
introduced in Europe in October'2003 and was approved by the United States Food
and Drug Administration (FDA) in March'2004. The EnPulse system incorporates
an array of unique features to help physicians optimize pacing therapy and simplify
patient care including a pioneering feature called Atrial Capture Management
(ACM), which enables the pacemaker to automatically adjust the electrical impulses
delivered to the hearts upper right chamber. The Enpulse joins our industry-leading
pacing product family, which includes the Kappa' 900 pacemaker, the worlds
most popular pacemaker, and the Medtronic AT500' pacing system, the first multiple-therapy
pacing system to treat various atrial heart rhythm problems.
Tachyarrhythmia is a potentially fatal condition that can lead to sudden cardiac
arrest (SCA), the sudden and complete cessation of heart activity. SCA is responsible
for approximately 450,000 deaths annually in the U.S., with most due to ventricular
fibrillation. Defibrillators are the only therapy proven to stop these life-threatening
episodes once they begin. Implantable cardioverter defibrillators (ICDs) are
stopwatch-sized devices that continually monitor the heart and deliver appropriate
therapy when an abnormal heart rhythm is detected. Several large clinical trials
have shown implantable defibrillators significantly improve survival as compared
to commonly prescribed antiarrhythmic drugs. In March'2004, the results of the
landmark Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), sponsored by
the National Institutes of Health (NIH), with funding provided by Medtronic
and Wyeth, were presented at the American College of Cardiology meeting. This
2,521-patient trial, the largest ICD trial ever conducted, showed ICDs reduced
death by 23'percent in people with moderate heart failure compared to those
who did not receive ICDs. Despite this mounting evidence, less than 20'percent
of all patients who are indicated for an ICD actually receive one, leaving hundreds
of thousands of people at risk for sudden cardiac death. SCA is the second-leading
cause of death in the U.S. and kills more people than AIDS, lung cancer, breast
cancer, and stroke combined, yet ICDs account for less than 0.2'percent of the
$1.6 trillion health care budget.
We offer the most comprehensive product choices to treat various kinds of tachyarrhythmias.
In October'2003, we announced the FDA approval of the Maximo' ICD, a high-output
ICD with the most advanced combination of delivered energy and features in the
industry. The Maximo is built on the platform of the Medtronic Marquis' ICD,
the most widely prescribed ICD in the world, and adds the clinical benefit of
35 joules of delivered energy. Devices based on the Marquis platform offer short
charge times for increased patient safety and improved longevity for less frequent
replacement. Marquis devices also offer our exclusive Cardiac Compass' system,
which helps physicians monitor cardiac disease progression for more effective
treatment. For patients who suffer from both ventricular and atrial tachyarrhythmias,
we offer the GEM III' AT' defibrillator.
The ICD market continues to experience a significant expansion, driven in part
by new guidelines issued last year by a joint committee of the American Heart
Association, the American College of Cardiology and the Heart Rhythm Society
recommending the use of antiarrhythmic devices in certain heart attack survivors
to reduce mortality. In addition, the ICD market benefited from the results
of Multicenter Automatic Defibrillator Implantation Trial (MADIT) II, a large
medical study that indicated the number of people proven to be at high risk
of sudden cardiac arrest has significantly increased. In June'2003, the Centers
for Medicare and Medicaid Services (CMS) expanded coverage of ICDs for Medicare
beneficiaries who meet certain MADIT II indicators. Additionally, in October'
2003, CMS implemented a new reimbursement structure for these newly covered
patients.
Heart failure is a large and growing health problem, afflicting nearly 5'million
Americans. Up to 550,000 new cases are diagnosed each year, making it the most
costly cardiovascular illness in the U.S., with an estimated $40'billion spent
on managing heart failure each year. We have pioneered innovative device-based
treatments for this progressive, debilitating disease. For patients suffering
from heart failure, we offer devices that provide cardiac resynchronization
therapy (CRT), which improves the efficiency of the heart by synchronizing the
contractions of multiple heart chambers. Our InSync' CRT system is the worlds
first tri-chamber heart device. The InSync III, our third generation cardiac
resynchronization device, has advanced programming functions to help physicians
better manage heart failure patients and is available in Europe and the U.S.
Continuing our leadership in research of device-based therapies to help the
millions of people afflicted with heart failure, we initiated a major new clinical
study in January'2004 called BLOCK HF. This study is designed to determine if
biventricular pacing can slow the perilous progression of heart failure in patients
with mild to moderate heart failure symptoms and the need for a pacemaker.
In fiscal year 2004 we introduced two new devices for the growing number of
patients with heart failure who are also considered at high risk of SCA. In
June'2003, we launched our fifth and most advanced CRT device, the InSync III
Marquis ICD system, in Europe. The InSync III Marquis device offers the improved
cardiac resynchronization function of the InSync III'' including biventricular
pacing for more precise pacing of the two lower chambers of the heart'' and
the advanced therapies of the Marquis ICD. The InSync III Marquis device is
currently under clinical evaluation in the U.S. In August'2003, we announced
FDA approval of the InSync II Marquis CRT with defibrillator back-up (CRT-D),
our third CRT system approved by the FDA in 2003. The InSync II Marquis system
offers independent, programmable ventricular outputs and unique heart failure
management reports, both designed to help physicians better manage each patients
specific heart failure condition. The InSync II Marquis system also offers unique
ICD therapies including anti-tachycardia pacing (ATP) options for the pain-free
termination of life-threatening tachyarrhythmias. The continued introduction
of these new CRT-D devices are an important clinical advance since SCA occurs
in heart failure patients at six to nine times the rate observed in the general
population.
Leads and associated delivery systems remain a significant contributor to our
leadership in the heart failure market. In January'2004, we announced the market
release of two new left heart delivery systems, Attain' Prevail' and Attain
Deflectable'. These devices represent the first steerable delivery systems designed
specifically for left heart lead placement. The Attain Prevail steerable catheter
system and the Attain Deflectable catheter delivery system are specifically
designed to help physicians navigate challenging heart anatomies during the
CRT implant procedure.
We continue to drive rapid technological advancement in therapies for heart
failure and have fifth-generation devices in development. In April'2004, we
announced the first clinical implants of our new family of pacemakers and ICDs'
' the EnRhythm' pacemaker and the EnTrust' ICD. This family represents our next
step in the delivery of premium implantable devices that include features such
as MVP' (Managed Ventricular Pacing), a new pacing mode that is designed to
promote natural heart activity by automatically minimizing unnecessary right
ventricular pacing. In addition to MVP, the EnTrust ICD will, for the first
time, offer anti-tachycardia pacing during charging of the capacitor. As a result,
the device is ready to deliver full power therapy when needed, but not before
it attempts to painlessly pace the patient out of the potentially life-threatening
rhythm.
Most recently, in June'2004, we announced the European market release of the
InSync Sentry' CRT-D. The Insync Sentry is the worlds first CRT-D with automatic
fluid status monitoring, which can be programmed to alert patients and clinicians
to changes in fluid accumulation in the lungs and thoracic cavity. When used
with other standard clinical assessments, this indicator offers the potential
for early warning of fluid accumulation and appropriate clinical response to
prevent hospitalization. Heart failure is the number one cause of hospital admissions,
and most of these admissions are due to fluid accumulation in the lungs, which
is extremely challenging to manage and often goes undetected until the patient
is critically ill.
Patient Management.'To achieve optimal results from our cardiac rhythm management
devices, physicians obtain diagnostic and therapeutic information collected
by the device and then tailor various device parameters to meet the individual
needs of each patient. This has historically required periodic office visits,
which increase health care costs and can inconvenience patients. The Medtronic
CareLink' Patient Management Network was developed to allow physicians to evaluate
patient information remotely via the internet, offering the potential for more
efficient chronic disease management and better patient outcomes. The Medtronic
CareLink Network is the first, and only, internet-based service that connects
cardiac device patients and physicians for "virtual office visits"
allowing patients with our heart devices to receive medical care from the comfort
of their home or even while traveling. Patients using the Medtronic CareLink
Network can send data about their heart and ICD activity to their physician
from anywhere in the 50 states by holding a small "antenna" over their
implanted device. The monitor automatically downloads the data and sends it
through a standard telephone connection directly to the secure Medtronic CareLink
Network. Clinicians access their patients data by logging onto the clinician
website from any internet-connected computer in their office, home or while
traveling. Patients also can view information about their device and condition
on their own personalized website, and family members or other caregivers can
view this information if granted access by the patient. The Medtronic CareLink
Network is currently available to nearly 400,000 pacemaker patients and approximately
130,000 patients with any of our mainline ICDs or CRT-Ds. Pacing devices compatible
with the Medtronic Carelink Network include the Kappa family and EnPulse pacemakers.
ICD and CRT-D devices compatible with the Medtronic Carelink Network include
the Medtronic GEM family, Marquis family, InSync family, and Maximo ICDs as
well as our InSync Marquis and InSync II Marquis CRT-Ds. Today, the Medtronic
Carelink system is being utilized in more than 150 electrophysiology clinics/practices
and nearly 9,000 patients are being monitored with the Medtronic CareLink system.
In the future, thousands of people with our other implantable cardiac devices
potentially could benefit from this innovative system, as it is designed to
support all of our implanted cardiac rhythm devices.
External Defibrillators.'Each day approximately 1,200 people die in the U.S.
due to SCA; however, most could be saved if they had quicker access to automated
external defibrillators. Nationally, the survival rate for victims of SCA is
less than 5% because the average response time to an emergency call for help
is six to twelve minutes. Chances of survival are reduced significantly if the
victim is not treated within five minutes. In November'2003, results from the
largest-ever clinical trial studying the outcomes of public access to defibrillation
(PAD) were presented at the American Heart Associations Annual Scientific Sessions
conference. The data indicated that the use of portable automatic external defibrillators
(AEDs) by trained volunteers can significantly improve the probability of saving
lives that otherwise might have been lost to SCA. Our LIFEPAK' series of external
defibrillators offers a broad range of life-saving tools for multiple user needs
and have been incorporated in environments ranging from hospitals to emergency
medical units to public places such as airports, sports arenas, schools and
workplaces. Today there are more than 350,000 LIFEPAK devices distributed worldwide.
In February'2004, we announced partnerships with Walgreens Co. and Costco Wholesale
Corporation to offer AEDs by prescription on their respective electronic commerce
web sites, www.walgreens.com and www.costo.com. These partnerships are designed
to help small businesses and consumers more easily access the life saving therapy
of AEDS to protect their customers and their families.
Spinal, Ear, Nose, and Throat and Surgical Navigation Technologies
Our Spinal, ENT and SNT business is well known for its innovative spinal products,
commitment to customers and unsurpassed technical support. Strong partnerships
with leading spine surgeons help us pioneer new and effective ways to treat
spinal conditions, and have propelled us to global leadership in the worldwide
spine market. We entered the spine market with the acquisition of Sofamor Danek
in fiscal year 1999. Also in fiscal year 2000, we acquired Xomed Surgical Products,'
Inc., the worlds leading ENT surgical product manufacturing company. Today
we offer a wide range of products and therapies to treat a variety of disorders
of the cranium and spine that often dramatically impair the quality of life,
as well as treat diseases and conditions affecting the ear, nose and throat.
Conditions Treated
Our Spinal, ENT, and SNT business offers products for treatment of the conditions
described below.
' Spinal disorders'' herniated disc, congenital spine disorders, degenerative
disc disease, tumor, trauma/fracture and stenosis
' Ear, Nose and Throat disorders'' diseases and conditions affecting the ear,
nose and throat such as chronic sinusitis and middle-ear infections
Principal Products
Our Spinal, ENT, and SNT products, used in surgical procedures of the head
and spine, include thoracolumbar, cervical and interbody spinal devices, bone
growth and bone regeneration, surgical navigation tools and surgical products
used by ENT physicians.
Spinal.'Back pain is the third most cited reason for visits to a health care
professional, after the common cold and routine check-ups. Each year nearly
20'million Americans experience back pain that is severe enough to visit a health
care professional. Of the nearly 20'million Americans, 11'million endure a significant
impairment of activity. We are committed to providing spine surgeons with the
most advanced options for treating low back pain and other spinal problems.
Today we offer the industrys broadest line of devices, instruments, computerized
image guidance products and biomaterials used in the treatment of spine disorders,
including a wide range of sophisticated internal bone fixation devices. Our
spinal products are used in spinal fusion of both the thoracolumbar (mid to
lower vertebrae) and cervical (upper spine and neck) regions of the spine. Spinal
fusions, which are currently one of the most common types of spine surgery,
essentially "weld" two or more vertebrae together to eliminate pain
caused by movement of the unstable vertebrae. Products used to treat spinal
disorders and deformities include rods and pedical screws, plating systems,
and interbody devices like spinal cages, bone dowels and bone wedges.
Our Spinal business leads the industry in the quest to find new surgical techniques
that offer the potential to dramatically improve patient recovery by changing
how surgeons access the spine. We have developed a series of Minimal Access
Spinal Technologies (MAST) that allow safe, reproducible access to the spine
with minimal disruption of vital muscles and surrounding structures. These techniques
involve the use of advanced navigation and instrumentation to allow surgeons
to operate with smaller incisions and less tissue damage than traditional surgeries,
thus reducing pain, blood loss and improving recovery periods. MAST techniques
have been described as having the same impact on spinal fusion surgery that
arthroscopy had on knee surgery. Our expanding portfolio of minimally invasive
spinal technologies now includes the CD HORIZON' SEXTANT' system, to facilitate
multi-level spinal fusion, the METRx' MicroDiscectomy System, to treat herniated
discs, and the CD HORIZON ECLIPSE' Spinal System, to correct curvature of the
spine in scoliosis patients. In November'2003, we acquired the Vertelink Corporation
(Vertelink), described under "Acquisitions and Investments" on page
17, further expanding our minimally invasive spine surgery options. Vertelink
has pioneered innovative materials and techniques for "over-the-wire"
spinal fixation devices that can achieve multi-level stabilization of the cervical,
thoracic and lumbar spine. Key Vertelink products include the KOBRA' Fixation
System and the SST' Spinal Fixation System. The KOBRA Fixation System obtained
FDA approval in the third quarter of fiscal year 2004. The SST Spinal Fixation
System is under review in Europe.
Introduced in July 2002, INFUSE' Bone Graft is rapidly becoming the standard
of care in spinal fusion therapy. INFUSE Bone Graft contains a recombinant human
bone morphogenetic protein, or rhBMP-2, which induces the body to grow its own
bone, eliminating the need for a painful second surgery to harvest bone from
elsewhere in the body. This product resulted from a strategic alliance with
Genetics Institute (now Wyeth) and demonstrates our commitment to the advancement
of science in the spine field. This past year our INFUSE Bone Graft technology
achieved a number of significant milestones. In May'2003, an analysis of several
high-quality studies published in the Journal of Spinal Disorder'& Techniques,
found that INFUSE Bone Graft, used in conjunction with the LT-CAGE' Lumbar Tapered
Fusion Device, delivered statistically better spinal fusion results with less
pain and blood loss, shorter recovery times, and fewer complications than transplanted
bone. In July'2003, CMS approved a special add-on payment for patients who undergo
spinal fusion surgery using INFUSE Bone Graft. This was the first time CMS has
approved such a payment for a new medical device. In August'2003, we reached
agreements with Wyeth and Yamanouchi Pharmaceutical Co.,'Ltd. to acquire the
remaining worldwide exclusive rights to promote rhBMP-2 for spine, orthopaedic
and trauma indications. In December'2003, we received FDA approval for the expanded
use of INFUSE Bone Graft with certain sizes of our INTER FIX' and INTER FIX
RP Threaded Fusion Devices. In May'2004, we announced that the FDA approved
the use of INFUSE Bone Graft in the treatment of acute, open fractures of the
tibial shaft, a long bone in the lower leg. The approval broadens the indications
for the use of our revolutionary INFUSE Bone Graft technology.
We are pursuing a broad array of solutions for patients suffering from degenerative
disc disease. We have three disc replacement programs currently under investigation
in the U.S.: the BRYAN' cervical disc, obtained through the acquisition of Spinal
Dynamics (SDC) in October'2002 described under "Acquisitions and Investments"
on page 17; the Maverick' Artificial Disc for the lumbar spine; and the Prestige',
an internally developed cervical disc. In May'2004, we announced the completion
of patient enrollment in our U.S. pivotal clinical trial for the Prestige artificial
disc and we are nearing the completion of enrollment in both the Maverick and
BRYAN trials. The BRYAN and Maverick artificial discs are commercially available
in Europe and we have sold approximately 8,000 devices thus far.
ENT.'We are the leading provider of products for ENT surgical specialists,
offering the broadest product line for the surgical treatment of ENT disorders,
including powered systems for tissue removal and sinus micro-endoscopy, image-guided
surgery systems, nerve monitoring systems, implantable devices and biomaterials.
Certain of these products are dramatically changing the way ENT medical procedures
are performed by replacing highly invasive procedures with new minimally invasive
instruments and techniques.
SNT.'Our image-guided surgery systems use sophisticated multi-dimensional imaging
and navigation technologies that enable surgeons to optimize their surgical
plans and use this advanced surgical information during the procedure and delivery
of therapies. Our FluoroNav' and iON' fluoroscopic navigation systems enable
intra-operative visualization and navigation for spinal and orthopedic procedures,
while significantly reducing radiation exposure for patients, physicians and
operating room staff. In October'2003, the Polestar' N-20 interoperative MRI
system, a product that we market on behalf of a third-party manufacturer, received
FDA clearance. The Polestar N-20 system is a compact, mobile MRI unit designed
to seamlessly integrate into the operating room. These advanced imaging and
navigation technologies enable physicians to perform safer and less invasive
surgical procedures.
Neurological and Diabetes'
Principal Products
Our neurological and diabetes products consist of therapeutic and diagnostic
devices, including implantable neurostimulation systems, external and implantable
drug administration devices, neurosurgery products, urology products, gastroenterology
products, hydrocephalic shunts and drainage devices, surgical instruments, functional
diagnostic equipment and medical systems for the treatment of diabetes.
Neurological.'We produce implantable systems that deliver drugs or electrical
stimulation to the spinal cord and brain to treat pain and movement disorders.
Our movement disorder therapies achieved several significant milestones during
the year, including the publication of a landmark article in the New England
Journal of Medicine that reported patients with advanced Parkinsons disease
experienced "marked improvement" in motor function and mobility when
treated with our bilateral deep brain stimulation technology, called Activa'
Therapy. Compared to baseline measures the article reports that, at five years,
patients with Activa Therapy showed significant improvement in motor function
(off medication) and activities of daily living. Additionally, in January'2004,
we announced the FDA approval of the Kinetra' Neurostimulator, along with its
Access' Therapy Controller, that simplify Activa Therapy for physicians and
patients by using one device to deliver deep brain stimulation therapy to both
sides of the brain.
In April'2004, we announced the start of the U.S. pivotal clinical trial for
the Intercept' Epilepsy Control System, our deep brain stimulation therapy for
patients with epilepsy. Epilepsy is a condition that affects more than 2.5'million
Americans, and about one-third of these people do not respond to current treatment
options and continue to experience seizures.
We have the medical device industrys broadest offering of implantable neurostimulators
designed to treat chronic debilitating pain, including our Synergy' and Synergy
Versitrel' systems, which deliver neurostimulation through one or two leads
surgically placed near the spinal cord. Stimulation patterns are adjustable
along multiple parameters, with the stimulation levels delivered by each lead
controlled separately.
We offer a complete line of implantable drug delivery systems, including both
programmable and fixed-rate devices that are used to treat chronic malignant
and non-malignant pain, spasticity and colorectal cancer that has spread to
the liver. In April'2004, we launched the SynchroMed' II, our newest drug delivery
system, in Europe and began limited release in the U.S. Full U.S. release of
the SynchroMed'II began in June'2004. The SyncroMed II is 30% smaller than the
SynchroMed EL, but has a larger reservoir and increased functionality. The SynchroMed
II drug delivery system is a small, programmable, implantable drug pump that
is placed in the abdomen together with a catheter that delivers medication directly
to the fluid-filled area that bathes the spinal cord. By delivering precise
doses of medication directly to the central nervous system, the SynchroMed II
drug delivery system reduces the amount of medication necessary to control pain
and spasticity, thereby minimizing undesirable side effects.
Our pain therapies also achieved significant milestones during fiscal year
2004. In March'2004, Pain Medicine (the official journal of the American Academy
of Pain Medicine) published an editorial "Intrathecal Drug Delivery for
Chronic Back Pain: Better Science for Clinical Innovation," providing valuable
prospective multi-center data on 136 patients receiving the SynchroMed II for
low back pain management. The twelve-month multi-center data included positive
results in the areas of back pain relief, functional disability reduction, and
patient satisfaction.
Our Strata' valve is a shunt used in the treatment of hydrocephalus, an abnormal
accumulation of cerebrospinal fluid in the ventricles of the brain. The Strata
valve diverts excess cerebrospinal fluid from the brain cavity to the abdomen
where it becomes reabsorbed by the body. Each year, about 160,000 people worldwide
receive a hydrocephalic shunt. Our neurological product group also includes
powered surgical tools, including pneumatic and electrical instrumentation devices
for surgical dissection of bones, biometals, bioceramics and bioplastics, as
well as instruments for use in orthopedic, otolaryngological, maxillofacial
and craniofacial procedures.
Diabetes.'Diabetes is a condition in which the body cannot properly use energy
from food, resulting in uncontrolled blood sugar levels. Diabetes has been described
as an epidemic, afflicting more than 170'million people worldwide. Approximately
20'million people have diabetes in the U.S., where it is now the fifth leading
cause of death. Currently, our products serve the insulin dependent population,
which includes over four million people in the U.S. The key to managing diabetes
is to maintain tight control of blood glucose levels. If not well-managed, diabetes
can lead to blindness, kidney failure and amputation. In fact, diabetes is the
leading cause of new cases of blindness (among twenty to seventy-four year olds),
end-stage renal disease, and non-traumatic lower-limb amputations in the U.S.
Diabetes is also a major factor in both heart disease and impotence. As a result,
diabetes is the most costly, chronic condition facing the U.S. health care system,
with more than $130'billion spent annually on diabetes and its complications,
including $90'billion in direct medical costs.
Our diabetes products are used for intensive insulin management and include
external pumps and related disposables, continuous glucose monitoring systems,
an implantable insulin pump (currently approved for distribution in Europe but
not yet cleared for marketing in the U.S.) and an implantable glucose sensor,
which is currently in U.S. clinical trials. Our pumps are primarily used by
patients with Type'1 diabetes, which occurs when the pancreas is unable to produce
insulin. In order to survive, people with Type'1 diabetes must administer insulin
using injections or an insulin pump. Our therapies are also helpful in managing
Type'2 diabetes, which results from the bodys inability to produce enough insulin
or properly use the insulin.
Our family of Paradigm' insulin infusion pumps are currently the leading choice
in insulin pump therapy. Worn on a belt like a pager, the Paradigm insulin infusion
pump offers a simplified and intuitive menu system to program insulin delivery,
making it easier for people with diabetes to manage their disease without injections.
Because pump therapy is more predictable than injections of insulin, it helps
diabetes patients better control their glucose levels within a near-normal range,
offering both short-term and long-term health benefits. In July'2003, we announced
the FDA clearance of the first "intelligent" insulin pump and glucose
monitoring system. The wireless system is comprised of a Paradigm 512 Insulin
Pump and a Paradigm Link' Blood Glucose Monitor, co-developed with Becton, Dickinson
and Company. Using wireless technology, the Paradigm Link monitor automatically
transmits a blood sugar reading to the Paradigm 512 insulin pump. The pumps
Bolus Wizard' calculator determines the recommended insulin dosage. In October'
2003, we launched the Paradigm 712 insulin pump in the U.S. The Paradigm 712
incorporates a larger reservoir for patients requiring more insulin to keep
their blood sugar levels in the normal range. Similar to the Paradigm 512 pump
system, the Paradigm 712 system wirelessly integrates blood sugar information
using the Paradigm Link Blood Glucose Monitor. In June'2003, we launched the
CGMS' System Gold enhanced continuous glucose monitoring system used by physicians
to identify unhealthy blood sugar patterns in people with diabetes. The monitoring
system can take up to 288 glucose measurements over a 24'hour period, providing
physicians with up to 72 times more information than typical glucose measurements
using finger sticks. In February'2004, we announced FDA approval of the Guardian'
Continuous Glucose Monitoring System, a patient-used device designed to protect
diabetes patients by alerting them to potentially dangerous fluctuations in
blood sugar levels. The Guardian system is an external device that utilizes
a glucose sensor to continuously record blood sugar readings and transmit the
information to a monitor, which is designed to sound an alarm when blood sugar
levels reach high or low limits preset by the patient or health care professional.
Information from the systems monitor can be downloaded to a computer for additional
trend analysis to further improve diabetes care.
Gastroenterology and Urology.'Our diagnostic and therapeutic products for gastroenterology
and urology include the Enterra' Therapy for gastroparesis, and the Bravo' pH
Monitoring System and Gatekeeper' Reflux Repair System for the evaluation and
treatment of GERD. Our gastroenterology and urology products also include our
InterStim' Therapy device for urinary and bowel control, our TUNA' (transurethral
needle ablation) Therapy for enlarged prostate, and our functional diagnostic
equipment.
In May'2003, the American Journal of Gastroenterology published the results
of a study that confirmed our Bravo pH Monitoring System, the first catheter-free
diagnostic system for measuring acid levels in the esophagus, is a "well-tolerated
and reliable" method for accurate diagnosis of GERD and yields better data
on esophageal pH levels than traditional techniques. GERD is a common and frequently
misdiagnosed disorder that is caused when the lower esophageal sphincter, which
separates the stomach from the esophagus, becomes weak and ineffective, allowing
stomach contents to flow back, or reflux, into the esophagus. In May'2003, we
received European regulatory approval of the Gatekeeper Reflux Repair System,
an innovative non-invasive treatment for GERD that uses biocompatible prostheses
to mimic a normal functioning barrier between the stomach and the esophagus.
In November'2003, we announced the start of the U.S. pivotal trial for the Gatekeeper
Reflux Repair System. Our InterStim Therapy device for urinary control treats
urinary retention and symptoms of an overactive bladder, including urinary urge
incontinence and significant symptoms of urgency-frequency, by delivering mild
electrical impulses to the sacral nerves with an implantable medical device
similar to a cardiac pacemaker. The sacral nerves, located in the lower back,
influence bladder function. In September'2003, we marked the 10,000th implant
of the InterStim therapy for urinary control. TUNA Therapy is designed to treat
benign prostatic hyperplasia (BPH), an aggressive and naturally occurring condition
that enlarges the prostate gland and afflicts more than 29'million men worldwide.
TUNA Therapy is a non-surgical procedure that uses low-level, precisely controlled
radio frequency energy to diminish prostate tissue while protecting adjacent
structures from harm. TUNA procedures reduce the risk of side effects, such
as incontinence and impotence, often associated with transurethral resection
of the prostrate, the standard surgical treatment for BPH.
Vascular
Principal Products
Our Vascular products include coronary, endovascular, and peripheral stents
and related delivery systems, stent graft systems, distal embolic protection
systems and a broad line of balloon angioplasty catheters, guide catheters,
guidewires, diagnostic catheters and accessories.
Coronary Stents.'If a blockage in a coronary artery prevents the heart from
receiving sufficient oxygen, the heart cannot function properly and a heart
attack or stroke may result. Coronary artery disease is commonly treated with
balloon angioplasty, a procedure in which a special balloon is threaded through
the coronary artery system to the site of the arterial blockage, where it is
inflated, pressing the obstructive plaque against the wall of the vessel to
improve blood flow. We offer a variety of balloon angioplasty catheters, including
our NC Stormer' and Sprinter' Semi-Compliant dilatation catheters. Our NC Stormer
dilatation catheter is available on both our Multi-Exchange' and Over-the-Wire
Balloon Dilatation Catheter systems, and received FDA clearance for U.S. commercial
sales in July 2003. The Sprinter Semi-Compliant dilatation catheter is presently
available in Europe and Japan and currently in U.S. clinical trials.
Following balloon angioplasty, physicians often place coronary stents at the
blockage site to prop open diseased arteries to maintain blood flow to the heart.
Stents are cylindrical, wire-mesh devices small enough to insert into coronary
arteries. Our new-generation coronary stent system, the Driver', is the first
modular stent to be composed of an advanced cobalt-based alloy, which surpasses
the limitations of stainless steel by creating very strong, ultra-thin struts
that offer excellent flexibility and vessel support. The Driver stent was launched
in the U.S. during October'2003. The Micro-Driver' coronary stent, specifically
designed for use in small vessels, was launched in Europe during June'2003 and
is currently in U.S. clinical trials.
Coating Technologies.'Like other companies in the stent market, we are developing
stents with drug coatings, known as drug-eluting stents, to inhibit the re-narrowing
or re-clogging of arteries, known as restenosis, after placement of a stent.
Our Endeavor' Drug-Eluting Coronary Stent combines an innovative delivery system
leveraging our discrete technology, our advanced Driver cobalt-alloy stent,
an effective drug'' ABT-578 (a rapamycin analogue), and a proprietary polymer
coating that controls the release of the drug into the vessel wall. In May'2002,
we entered into a ten year agreement with Abbott Laboratories (Abbott) granting
us co-exclusive use of Abbotts proprietary immunosupressant drug ABT-578, as
well as the phosphoryl choline coating Abbott has licensed from Biocompatibles
International PLC for use in conjunction with ABT-578. Clinical studies have
shown that this proprietary biocompatible polymer is a safe, polymeric drug-eluting
platform.
Our three-phase Endeavor Drug-Eluting Coronary Stent clinical trial program
achieved a number of significant milestones during fiscal year 2004. In September'
2003, the principal investigator for the ENDEAVOR I, a 100-patient feasibility
clinical trial, reported positive four-month results at the Transcatheter Cardiovascular
Therapeutics annual symposium. In May'2004, 12-month data for ENDEAVOR I was
presented at the Paris Course on Revascularization demonstrating continued favorable
results. In July'2003, we started our Pivitol Clinical Trial, ENDEAVOR II, and
completed enrollment of the 1,200-patient trial in January'2004. ENDEAVOR II
is currently in the follow-up phase and results are expected to be presented
in March'2005 at the American College of Cardiology annual scientific meeting.
In February'2004, we started the third and final phase of our drug-eluting stent
program, ENDEAVOR III, a 436-patient equivalency study comparing our Endeavor
Drug-Eluting Coronary Stent to the Johnson'& Johnson Cypher' Sirolimus-eluting
stent. We anticipate completing enrollment in ENDEAVOR III during the middle
of calendar year 2004. We continue to progress toward the European and U.S.
launches of our Endeavor Drug-Eluting Stent, which will be the first drug-eluting
stent utilizing the advanced technology of a cobalt-alloy stent.
Embolic Protection System.'Embolic protection systems are designed to capture
debris dislodged from the wall of the vessel, during balloon angioplasty or
placement of a stent, that might otherwise flow downstream toward the heart
and result in complications such as a heart attack or stroke. Our GuardWire
Plus' system is the first embolic protection system commercially available in
the U.S. and is indicated for use in vein graft interventions for certain individuals
who have previously undergone coronary artery bypass graft surgery.
Endovascular Stent Grafts and Peripheral Stents.'Our Vascular product line
includes a range of endovascular stent grafts and other peripheral vascular
products. These include the market-leading AneuRx' and Talent' stent grafts
for minimally invasive AAA and TAA repair. Our AneuRx stent graft system is
available in the U.S. and Europe, while the Talent stent graft system is available
only in Europe. In November'2003, we announced the start of the VALOR (Evaluation
of the Safety and Efficacy of the Medtronic Vascular Talent Thoracic Stent Graft
System for the Treatment of Thoracic Aortic Aneurysms) study. This study is
an important step in establishing treatment options for patients with life-threating
thoracic aneurysms. We also offer balloon expandable and self-expanding biliary
stents that are designed to maintain bile flow in liver ducts restricted or
blocked by malignant tumors. In August'2003, we announced FDA clearance of our
next generation Aurora' Self-Expandable Stent System and in November'2003, our
Racer' Biliary Stent became the first cobalt-alloy biliary stent commercially
available for use in the U.S.
Cardiac Surgery
We have competed in the Cardiac Surgery marketplace for over two decades, and
are the worldwide market leader with solid platforms in revascularization, heart
valve repair and replacement, and blood management. We offer cardiac surgeons
the industrys broadest range of products for use in the operating room. Together
our Cardiac Surgery, CRM and Vascular businesses offer an extensive array of
products and services for cardiac care.
Our cardiac surgery products are used in the treatment of the conditions described
below.
' Coronary artery disease'' in patients who cannot be effectively treated with
angioplasty or stents
' Heart valve disorders'' diseased or damaged heart valves can restrict blood
flow or leak. This limits the hearts ability to pump blood, and makes the heart
work harder to meet the needs of the circulatory system.
Coronary Artery Bypass Surgery.'When physicians determine that they cannot
effectively treat a blockage in a coronary artery using balloon angioplasty
or a stent, they typically turn to cardiac surgery to address the problem. The
most common surgical procedure used to treat blockage in a coronary artery is
a coronary artery bypass graft (CABG). In a CABG procedure, surgeons re-route
the blood flow around the blockage by attaching a graft, usually from an artery
or vein from another part of the patients body, as an alternative pathway to
the heart. Approximately 820,000 bypass procedures are performed each year worldwide.
There are two primary techniques, arrested heart surgery and beating heart surgery
described as follows.
Arrested Heart Surgery.'In a conventional coronary artery bypass procedure,
the patients heart is temporarily stopped, or arrested. The patient is placed
on a circulatory support system that temporarily replaces the patients heart
and lungs and provides blood flow to the body. We offer a complete line of blood-handling
products that form this circulatory support system and maintain and monitor
blood circulation and coagulation status, oxygen supply and body temperature
during open heart surgery. The Magellan' Autologous Platelet Separator, which
continues to experience a small but growing acceptance, is part of our circulatory
support systems and benefits patients in a variety of ways, including a reduction
in the risk of infection. As beating heart surgery has become more popular,
the market for arrested heart surgery products has been declining. For patients
undergoing cardiac surgery, who also suffer from atrial arrhythmias, our Cardioblate'
Ablation System is designed to allow surgeons to efficiently restore a normal
heart rhythm by neutralizing the cells causing troublesome electrical activity.
In August'2003, we announced the first use of our Cardioblate BP (Bipolar) system,
the latest addition to our Cardioblate Surgical Ablation Systems. The Cardioblate
BP system is the worlds first bipolar surgical radio frequency (RF) ablation
instrument that delivers an electrolytic irrigation solution along with its
RF energy.
Beating Heart Surgery.'Increasingly, physicians are performing coronary artery
bypass surgery on the beating heart to avoid the complexity and potential risks
of arresting the heart. To assist physicians performing beating heart surgery,
we offer positioning and stabilization technologies. These technologies include
our Starfish' 2 and Urchin' heart positioners, which use suction technology
to gently lift and position the beating heart to expose arteries on any of its
surfaces. These heart positioners are designed to work in concert with our Octopus'
4.3 tissue stabilizer, which holds a small area of the cardiac surface tissue
nearly stationary while the surgeon is suturing the bypass grafts to the arteries.
It is currently estimated that beating heart surgeries make up about 25% of
the more than 300,000 coronary artery bypass surgeries that take place in the
U.S. each year. In April'2004, the results of a study published in the Journal
of the American Medical Association provided compelling evidence of the benefits
of performing CABG surgery while the patients heart is still beating.
Heart Valves.'We offer a complete product line of valve replacement and repair
products for damaged or diseased heart valves. Our replacement products include
both tissue and mechanical valves. The valve market continues to shift from
mechanical to tissue valves, which is beneficial to us due to our broad selection
of tissue valve products. Our Mosaic' bioprosthetic heart valve is a reduced-profile
valve engineered from porcine tissue incorporating a proven flexible stent.
The low profile and flexibility of the stent make it easier for the surgeon
to implant the valve. Other tissue product offerings include the Freestyle'
and Hancock' II. Our mechanical heart valve offerings include the Medtronic
Hall', currently available in the U.S., and the ADVANTAGE Supra' bileaflet,
which was released in Europe during November 2003; the bileaflet valve is designed
to allow the implantation of a larger valve thereby optimizing blood flow. Currently,
the bileaflet valve is in U.S. clinical evaluation. Our repair products include
the Duran Flexible and CG Future' Band annuloplasty systems. In November'2003,
we announced that a Humanitarian Device Exception had been approved by the FDA,
making our Contegra' Pulmonary Valved Conduit available to correct congenital
defects of the right side of the heart in children.
Surgical Technologies
Our Surgical Technologies business develops, manufactures, and markets products
and therapies to treat diseases and conditions of the ear, nose, and throat
(ENT) and certain neurological disorders. In addition, the business develops,
manufactures, and markets image-guided surgery and intra-operative imaging systems
that facilitate surgical planning during precision cranial, spinal, sinus, and
orthopedic surgeries.
The following are the principal products offered by our Surgical Technologies
business:
ENT. The following products treat ENT diseases and conditions: PEAK PlasmaBlade
TnA (Tonsil and Adenoid) Tissue Dissection Device, NIM Nerve Monitoring Systems,
Fusion ENT Navigation System, Hydrodebrider Endoscopic Sinus Irrigation System,
Meniett Device for Meniere’s Disease, Pillar Procedure for Snoring and
Sleep Apnea, and Repose System for Obstructive Sleep Apnea.
Neurological Technologies. The following products treat certain neurological
disorders and conditions: Midas Rex Spine Shaver, the Midas Rex MR7 Pneumatic
Platform, the Midas Rex Legend EHS High Speed Surgical Drill, the Strata Family
of Adjustable Valves for the treatment of Hydrocephalus, Duet External Drainage
& Monitoring System, the IPC System, and the Subdural Evacuating Port System.
Navigation. The following products are used in cranial, spinal, sinus, and
orthopedic surgeries: the StealthStation S7 Navigation and i7 Integrated Navigation
Systems, the O-Arm 2D/3D Surgical Imaging System, and the PoleStar Surgical
MRI System.
|
Total reportable segment net sales |
|
100.66 % |
of total Revenue |
Cardiovascular |
|
37.99 % |
of total Revenue |
Cardiovascular Cardiac Rhythm & Heart Failure |
|
19.39 % |
of total Revenue |
Cardiovascular Structural Heart & Aortic |
|
10.81 % |
of total Revenue |
Cardiovascular Coronary & Peripheral Vascular |
|
7.78 % |
of total Revenue |
Neuroscience |
|
29.27 % |
of total Revenue |
Neuroscience Cranial & Spinal Technologies |
|
14.49 % |
of total Revenue |
Neuroscience Specialty Therapies |
|
9.01 % |
of total Revenue |
Neuroscience Neuromodulation |
|
5.77 % |
of total Revenue |
Medical Surgical |
|
25.22 % |
of total Revenue |
Medical Surgical Surgical & Endoscopy |
|
19.51 % |
of total Revenue |
Medical Surgical Acute Care & Monitoring |
|
5.71 % |
of total Revenue |
Diabetes |
|
8.17 % |
of total Revenue |
All other operating segments |
|
100 % |
of total Revenue |
Other Adjustments |
|
-1.14 % |
of total Revenue |
U.S. |
|
51.57 % |
of total Revenue |
International |
|
48.41 % |
of total Revenue |
International Other Adjustments |
|
-1.14 % |
of total Revenue |
Total reportable segment net sales U.S. |
|
51.35 % |
of total Revenue |
Total reportable segment net sales International |
|
49.31 % |
of total Revenue |
Cardiovascular U.S. |
|
17.73 % |
of total Revenue |
Cardiovascular International |
|
20.27 % |
of total Revenue |
Neuroscience U.S. |
|
19.77 % |
of total Revenue |
Neuroscience International |
|
9.5 % |
of total Revenue |
Medical Surgical U.S. |
|
11.13 % |
of total Revenue |
Medical Surgical International |
|
14.09 % |
of total Revenue |
Diabetes U.S. |
|
2.72 % |
of total Revenue |
Diabetes International |
|
5.46 % |
of total Revenue |
Other |
|
0.48 % |
of total Revenue |
Other U.S. |
|
0.23 % |
of total Revenue |
Other International |
|
0.24 % |
of total Revenue |
Ireland |
|
0.38 % |
of total Revenue |
Total other countries, excluding Ireland |
|
99.62 % |
of total Revenue |
United States |
|
51.57 % |
of total Revenue |
Rest of world |
|
48.05 % |
of total Revenue |
Q1 three months ended (Jul 26 2024)
|
Revenues by Business Segments |
Revenues (in millions $) |
%
(of total Revenues) |
Total |
7,915.00 |
100 % |
Total reportable segment net sales |
7,967.00 |
100.66 % |
Cardiovascular |
3,007.00 |
37.99 % |
Cardiovascular Cardiac Rhythm & Heart Failure |
1,535.00 |
19.39 % |
Cardiovascular Structural Heart & Aortic |
856.00 |
10.81 % |
Cardiovascular Coronary & Peripheral Vascular |
616.00 |
7.78 % |
Neuroscience |
2,317.00 |
29.27 % |
Neuroscience Cranial & Spinal Technologies |
1,147.00 |
14.49 % |
Neuroscience Specialty Therapies |
713.00 |
9.01 % |
Neuroscience Neuromodulation |
457.00 |
5.77 % |
Medical Surgical |
1,996.00 |
25.22 % |
Medical Surgical Surgical & Endoscopy |
1,544.00 |
19.51 % |
Medical Surgical Acute Care & Monitoring |
452.00 |
5.71 % |
Diabetes |
647.00 |
8.17 % |
All other operating segments |
7,915.00 |
100 % |
Other Adjustments |
-90.00 |
-1.14 % |
U.S. |
4,082.00 |
51.57 % |
International |
3,832.00 |
48.41 % |
International Other Adjustments |
-90.00 |
-1.14 % |
Total reportable segment net sales U.S. |
4,064.00 |
51.35 % |
Total reportable segment net sales International |
3,903.00 |
49.31 % |
Cardiovascular U.S. |
1,403.00 |
17.73 % |
Cardiovascular International |
1,604.00 |
20.27 % |
Neuroscience U.S. |
1,565.00 |
19.77 % |
Neuroscience International |
752.00 |
9.5 % |
Medical Surgical U.S. |
881.00 |
11.13 % |
Medical Surgical International |
1,115.00 |
14.09 % |
Diabetes U.S. |
215.00 |
2.72 % |
Diabetes International |
432.00 |
5.46 % |
Other |
38.00 |
0.48 % |
Other U.S. |
18.00 |
0.23 % |
Other International |
19.00 |
0.24 % |
Ireland |
30.00 |
0.38 % |
Total other countries, excluding Ireland |
7,885.00 |
99.62 % |
United States |
4,082.00 |
51.57 % |
Rest of world |
3,803.00 |
48.05 % |
Q1 three months ended (Jul 26 2024) |
Revenue Growth rates by Segment |
Y/Y Revenue % |
Q/Q Revenue % |
Total |
2.77 % |
- |
Total reportable segment net sales |
4.12 % |
- |
Cardiovascular |
5.51 % |
- |
Cardiovascular Cardiac Rhythm & Heart Failure |
6.15 % |
- |
Cardiovascular Structural Heart & Aortic |
5.16 % |
- |
Cardiovascular Coronary & Peripheral Vascular |
4.58 % |
- |
Neuroscience |
4.42 % |
- |
Neuroscience Cranial & Spinal Technologies |
3.99 % |
- |
Neuroscience Specialty Therapies |
2.59 % |
- |
Neuroscience Neuromodulation |
8.81 % |
- |
Medical Surgical |
-0.45 % |
- |
Medical Surgical Surgical & Endoscopy |
-0.13 % |
- |
Medical Surgical Acute Care & Monitoring |
-1.53 % |
- |
Diabetes |
11.94 % |
- |
All other operating segments |
2.77 % |
- |
Other Adjustments |
- |
- |
U.S. |
4.03 % |
- |
International |
1.46 % |
- |
International Other Adjustments |
- |
- |
Total reportable segment net sales U.S. |
4.13 % |
- |
Total reportable segment net sales International |
4.11 % |
- |
Cardiovascular U.S. |
3.93 % |
- |
Cardiovascular International |
6.93 % |
- |
Neuroscience U.S. |
4.54 % |
- |
Neuroscience International |
4.3 % |
- |
Medical Surgical U.S. |
1.61 % |
- |
Medical Surgical International |
-1.93 % |
- |
Diabetes U.S. |
14.36 % |
- |
Diabetes International |
10.77 % |
- |
Other |
-24 % |
- |
Other U.S. |
-18.18 % |
- |
Other International |
-32.14 % |
- |
Ireland |
3.45 % |
- |
Total other countries, excluding Ireland |
2.76 % |
- |
United States |
4.03 % |
- |
Rest of world |
1.44 % |
- |
Q1 three months ended (Jul 26 2024) |
Income by Business Segments |
Income (in millions $) |
%
(Profit Margin) |
All other operating segments |
1,268.00 |
16.02 % |
Q1 three months ended (Jul 26 2024) |
Income Growth rates by Segment |
Y/Y Income % |
Q/Q Income % |
All other operating segments |
6.02 % |
- |
|