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Mettler toledo International Inc   (MTD)
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Mettler toledo International Inc Segments

 
 

Business Segments III. Quarter
Revenues
(in millions $)
(Sep 30 2019)
%
(of total Revenues)
III. Quarter
Income
(in millions $)
(Sep 30 2019)
%
(Profit Margin)
Total
753.87 100 % 129.40 17.16 %

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Growth rates by Segment III. Quarter
Y/Y Revenue
%
(Sep 30 2019)
Q/Q Revenue
%
III. Quarter
Y/Y Income
%
(Sep 30 2019)
Q/Q Income
%
Total
4.41 % 3.08 % 16.08 % 1.76 %

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  Mettler Toledo International Inc 's

Business Segments Description



Cardiac Rhythm Management

We are the world's 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 world's 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 world's leading provider of pacing systems, offering the broadest and most complete line of pacemakers, leads and related accessories. Our EnPulse® pacemaker, the world's 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 heart's upper right chamber. The Enpulse joins our industry-leading pacing product family, which includes the Kappa® 900 pacemaker, the world's 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 world's 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 patient's 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 world's 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 Association's 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 world's 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 industry's 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 Parkinson's 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 industry's 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 body's 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 pump's 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 system's 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 Abbott's 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 industry's 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 heart's 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 patient's 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 patient's heart is temporarily stopped, or arrested. The patient is placed on a circulatory support system that temporarily replaces the patient's 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 world's 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 patient's 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.

   

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