Cardiovascular
Coronary Stent Business
Drug-Eluting Stents
During the fourth quarter of 2006, we launched our PROMUS™ everolimus-eluting
coronary stent system in certain European countries, expanding our drug-eluting
stent portfolio to include two distinct drug platforms. We expect to launch the
PROMUS stent system in certain Inter-Continental countries during the second quarter
of 2007 and in the U.S. in 2008, subject to regulatory approval. We also expect
to launch an internally manufactured next-generation everolimus-based stent system
in Europe in 2010 and in the U.S. in 2011. In addition, we have commenced regulatory
filings to begin clinical trials for our next-generation paclitaxel-eluting stent
beyond TAXUS Liberté stent system, the TAXUS® Element™ coronary stent system,
which we expect to launch in Europe in 2009 and in the U.S. in 2010, subject to
regulatory approval.
Bare-Metal Stents
We offer our Liberté coronary stent system globally. The Liberté coronary stent
system serves as the platform for our second-generation paclitaxel-eluting stent
system, the TAXUS Liberté coronary stent system. The Liberté bare-metal coronary
stent is designed to enhance deliverability and conformability, particularly in
challenging lesions.
Cardiac Surgery
Our acquisition of Guidant also enabled us to enter the cardiac surgery business.
Cardiac surgery devices are used to perform endoscopic vessel harvesting, cardiac
surgical ablation and less-invasive coronary artery by-pass surgery.
Coronary Revascularization
We market a broad line of products used to treat patients with atherosclerosis.
Atherosclerosis, a principal cause of coronary artery obstructive disease, is
characterized by a thickening of the walls of the coronary arteries and a narrowing
of arterial lumens (openings) caused by the progressive development of deposits
of plaque. The majority of our products in this market are used in percutaneous
transluminal coronary angioplasty (PTCA) and include bare-metal and drug- eluting
stents, such as the TAXUS® paclitaxel-eluting coronary stent systems, PTCA balloon
catheters, such as the Maverick® balloon catheter, the Cutting Balloon® microsurgical
dilatation device, rotational atherectomy systems, guide wires, guide catheters
and diagnostic catheters. We also market a broad line of fluid delivery sets,
pressure monitoring systems, custom kits and accessories that enable the injection
of contrast and saline or otherwise facilitate cardiovascular procedures.
Intraluminal Ultrasound Imaging
We market a family of intraluminal catheter-directed ultrasound imaging catheters
and systems for use in coronary arteries and heart chambers as well as certain
peripheral systems. In July 2006, we launched the new iLab™ Ultrasound Imaging
System in the U.S. This new system enhances the diagnosis and treatment of blocked
vessels and heart disorders.
Embolic Protection
Our FilterWire EZ™ Embolic Protection System is a low profile filter designed
to capture embolic material that may become dislodged during a procedure, which
could otherwise travel into the microvasculature where it could cause a heart
attack or stroke. It is commercially available in the U.S., Europe and other international
markets for multiple indications, including the treatment of disease in peripheral,
coronary and carotid vessels. It is also available in the U.S. for the treatment
of saphenous vein grafts (SVGs) and carotid artery stenting procedures.
Peripheral Interventions
We also sell various products designed to treat patients with peripheral disease
(disease which appears in blood vessels other than in the heart and in biliary
strictures), including a broad line of medical devices used in percutaneous transluminal
angioplasty and peripheral vascular stenting. Our peripheral product line includes
vascular access products, balloon catheters, stents and peripheral vascular catheters,
wires and accessories. We also market the PolarCath™ peripheral dilatation system
used in CryoPlasty® Therapy®, an innovative approach to the treatment of peripheral
artery disease in the lower extremities. We launched in June 2006 the Sterling™
Balloon dilatation catheter, a dilatation catheter with several differentiating
features, including the only pre- and post-stent dilatation indication for carotid
artery stenting.
In January 2007, we completed the acquisition of EndoTex Interventional Systems,
Inc., a development stage medical device company, and now market the NexStent®
Carotid Stent System, a laser-cut, nitinol stent with a rolled sheet design that
enables one stent size to adapt to multiple diameters in tapered or non-tapered
vessel configurations.
Neurovascular Intervention
We market a line of coils (coated and uncoated), micro-delivery stents, micro-guidewires,
micro-catheters, guiding catheters and embolics to neuroradiologists and neurosurgeons
to treat diseases of the neurovascular system. We market the GDC® Coils (Guglielmi
Detachable Coil) and Matrix® systems to treat brain aneurysms. We also offer the
Wingspan™ Stent System with Gateway™ PTA Balloon Catheter under a Humanitarian
Device Exemption (HDE) approval granted by the FDA. The Wingspan Stent System
is designed to treat atherosclerotic lesions or accumulated plaque in brain arteries.
Designed for the brain’s fragile vessels, the Wingspan Stent System is a self-expanding,
nitinol stent sheathed in a delivery system that enables it to reach and open
narrowed arteries in the brain. The Wingspan Stent System is currently the only
device available in the U.S. for the treatment of intracranial atherosclerotic
disease (ICAD) and is indicated for improving cerebral artery lumen diameter in
patients with ICAD who are unresponsive to medical therapy.
Vascular Surgery
We design abdominal, thoracic and peripheral vascular grafts for the treatment
of aortic aneurysms and dissections, peripheral vascular occlusive diseases and
dialysis access. Our grafts and fabrics are used for peripheral vascular and cardiovascular
indications.
Electrophysiology
We offer medical devices for the diagnosis and treatment of cardiac conditions
called arrhythmias (abnormal heartbeats). Included in our product offerings are
RF generators, mapping systems, intracardiac ultrasound and steerable ablation
catheters, as well as a line of diagnostic catheters and associated accessories.
We also market the Chilli II™ cooled ablation catheter, the first bidirectional
cooled-tip catheter available in the U.S. In 2006, we launched our next-generation
line of RF generators, the MAESTRO 3000® Cardiac Ablation System.
Cardiac Rhythm Management
Through our acquisition of Guidant, we now offer a variety of implantable devices
that can monitor the heart and deliver electricity to treat cardiac rhythm abnormalities,
including tachycardia (abnormally fast or chaotic heart rhythms), heart failure
and bradycardia (slow or irregular heart rhythms).
Our product offerings include:
· the VITALITY® family of defibrillators which provide a broad range of atrial
(upper chambers of the heart) and ventricular (lower chambers) therapies to serve
patients’ various needs;
· cardiac resynchronization therapy devices, like those in our CONTAK RENEWAL®
family of devices, which can help reduce mortality and hospitalization;
· the INSIGNIA® family of pacemakers which offer proprietary blended sensor
technology designed to measure patient workload through respiration and motion,
providing rate response based on the patient’s activity; and
· the LATITUDE® Patient Management System, comprised of the LATITUDE Communicator,
LATITUDE Website, CONTAK RENEWAL 3RF CRT-D and ZOOM® LATITUDE Programmer, which
enables a physician or technician to monitor a patient’s device status and health
data from home.
In October 2006, the FDA approved our LATITUDE® Patient Management System to
be used for remote monitoring in certain existing ICD systems and cardiac resynchronization
defibrillators. We are in the process of making this technology available to
many of our current CRM patients.
The Frontier™ CRM technology is our next-generation CRM pulse generator platform
that will incorporate new components and software and will be leveraged across
all CRM product lines to treat electrical dysfunction in the heart. We expect
to launch various products based on the Frontier™ CRM technology in the U.S.
over the next 36 months, subject to regulatory approval.
Endosurgery
Esophageal, Gastric and Duodenal (Small Intestine) Intervention
We market a broad range of products to diagnose, treat and palliate a variety
of gastrointestinal diseases and conditions, including those affecting the esophagus,
stomach and colon. Common disease states include esophagitis, portal hypertension,
peptic ulcers and esophageal cancer. Our products in this area include disposable
single and multiple biopsy forceps, balloon dilatation catheters, hemostasis
catheters and enteral feeding devices. We also market a family of esophageal
stents designed to offer improved dilatation force and greater resistance to
tumor in-growth. We launched the Radial Jaw® 4 Single-Use Biopsy Forceps, the
newest version of our Radial Jaw Single-Use Biopsy Forceps, in July 2006. The
Radial Jaw 4 biopsy forceps are designed to enable collection of large high-quality
tissue specimens without the need to use large channel therapeutic endoscopes.
Colorectal Intervention
We market a line of hemostatic catheters, polypectomy snares, biopsy forceps,
enteral stents and dilatation catheters for the diagnosis and treatment of polyps,
inflammatory bowel disease, diverticulitis and colon cancer.
Pancreatico-Biliary Intervention
We sell a variety of products to diagnose, treat and palliate benign and malignant
strictures of the pancreatico-biliary system (the gall bladder, common bile
duct, hepatic duct, pancreatic duct and the pancreas) and to remove stones found
in the common bile duct. Our products include diagnostic catheters used with
contrast media, balloon dilatation catheters and sphincterotomes. We also market
self-expanding metal and temporary biliary stents for palliation and drainage
of the common bile duct. In 2006, we introduced the Spyglass™ Direct Visualization
System for direct imaging of the bile duct system. This is the first single
operator cholangioscopy device that offers clinicians a direct visualization
of the bile duct system and includes supporting devices for tissue acquisition,
stone retrieval and lithotripsy.
Pulmonary Intervention
We market devices to diagnose, treat and palliate diseases of the pulmonary
system. The major devices include pulmonary biopsy forceps, transbronchial aspiration
needles, cytology brushes and tracheobronchial stents used to dilate strictures
or for tumor management.
Urinary Tract Intervention and Bladder Disease
We sell a variety of products designed primarily to treat patients with urinary
stone disease, including ureteral dilatation balloons used to dilate strictures
or openings for scope access; stone baskets used to manipulate or remove the
stone; intracorporeal shock wave lithotripsy devices and holmium laser systems
used to disintegrate stones; ureteral stents implanted temporarily in the urinary
tract to provide short-term or long-term drainage; and a wide variety of guidewires
used to gain access to a specific site. We have also developed other devices
to diagnose and treat bladder cancer and bladder obstruction.
Prostate Intervention
For the treatment of Benign Prostatic Hyperplasia (BPH), we currently market
electro-surgical resection devices designed to resect large diseased tissue
sites. We also market disposable needle biopsy devices, designed to take core
prostate biopsy samples. In addition, we distribute and market the Prolieve
thermodilatation system, a transurethral microwave thermotherapy system, and
the DuoTome™ SideLite™ holmium laser treatment system for treatment of symptoms
associated with BPH.
Pelvic Floor Reconstruction and Urinary Incontinence
We market a line of less-invasive devices to treat female pelvic floor conditions
in the area of stress urinary incontinence and pelvic organ prolapse. These
devices include a full line of mid-urethral sling products, sling materials,
graft materials, suturing devices and injectables. In May 2006, we were granted
exclusive U.S. distribution rights to the Coaptite® Injectable Implant, a next-generation
bulking agent, for the treatment of stress urinary incontinence.
Gynecology
We also market other products in the area of women’s health. Our Hydro ThermAblator®
System (HTA® system) offers a less-invasive technology for the treatment of
excessive uterine bleeding by ablating the lining of the uterus, the tissue
responsible for menstrual bleeding.
Oncology
We market a broad line of products designed to treat, diagnose and palliate
various forms of benign and malignant tumors. Our current suite of products
includes microcatheters, embolic agents and coils designed to restrict blood
supply to targeted sites. In addition, we market radiofrequency-based therapeutic
devices for the ablation of various forms of soft tissue lesions (tumors). Also
included in the oncology portfolio is a complete line of venous access products
which are marketed for infusion therapy.
Neuromodulation
Cochlear Implants
We develop and market in the U.S., Europe and Japan the HiResolution® 90K Cochlear
Implant System to restore hearing to the profoundly deaf. The technology consists
of an external sound processor, which captures and processes sound information
from the environment and transmits the digital information through the skin
to the implant. The implant delivers digital pulses of electrical current to
precise locations on the auditory nerve, which the brain perceives as sound.
In September 2006, our next-generation cochlear implant technology, the Harmony™
HiResolution Bionic Ear System was approved by the FDA. We commercially launched
this product on a limited basis in late 2006 and anticipate a full launch in
early 2007.
Pain Management
We market the Precision® Spinal Cord Stimulation System for the treatment of
chronic pain of the lower back and legs. This system delivers advanced pain
management by applying a small electrical signal to mask pain signals traveling
from the spinal cord to the brain. The Precision System utilizes a rechargeable
battery and features a patient-directed fitting system for fast and effective
programming. The Precision System is also being assessed for use in treating
migraine pain.