Good news on the CHF devices from MDT. This news is very important on two fronts. These systems represent major growth opportunities going forward and they are first to market in Europe. It will be interesting to follow the acceptance rate to get an indication of the market potential. These CHF products alone could put major egg on the Barron's article that predicted slower growth for MDT.
Any comments,
Mike
Medtronic Announces European Release of New InSync(R) ICD System that Treats Two Heart Problems: Heart Failure and Sudden Cardiac Death
Innovative New Lead for Left Ventricular Access, Attain(TM) Side-Wire Model 4191 Also Goes on European Market
NICE, France, June 14 /PRNewswire/ -- Offering one solution for patients with two high-risk heart conditions -- heart failure and sudden cardiac death -- Medtronic, Inc. (NYSE: MDT), today announced commercial release outside the United States of its Medtronic InSync(R) ICD (implantable cardioverter defibrillator) cardiac resynchronization system.
(Photo:http://www.newscom.com/cgi-bin/prnh/20000224/MDTLOGO )
The company also announced commercial release outside the United States of the Attain(TM) Side-Wire Lead Model 4191,
an electrical conduction lead designed to help physicians cross a new medical frontier: delivering electrical resynchronization impulses transvenously to the left ventricle of the heart.
The innovative InSync ICD system is designed to provide two distinct therapies: cardiac resynchronization, which is intended to improve pumping action by stimulating the left and right sides of failing hearts that have ventricular conduction delays, and ventricular tachyarrhythmia termination and defibrillation, which protects patients whose heart rhythms may escalate to the lethal
condition called fibrillation. For patients without defibrillation therapy, sudden cardiac death ensues in minutes.
Steve Mahle, president of Medtronic Cardiac Rhythm Management, told the world's cardiologists and electrophysiologists gathered at the Cardiostim 2000 International Congress here that the InSync ICD system is a new product platform that includes proven Medtronic pacing and defibrillation technologies and new resynchronization capabilities intended to provide therapeutic flexibility and an "extra margin of safety" for heart failure patients chronically at high risk.
The system senses rapid rhythms or tachycardias only in the right ventricle, thus avoiding signal confusion and inappropriate defibrillation therapies while allowing optimal resynchronization therapies. The system also can be programmed to pace left or right chambers individually or simultaneously. This chamber-specific flexibility may simplify cardiac measurements during patient
follow-up visits.
Prof. Dr. D. Horstkotte, Director, Cardiology Department, Herz und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen, Germany, emphasized quality of life and peace of mind when asked to characterize the patient benefits. "Now, for the first time, we can discharge patients with multiple, complex risk patterns and give them a degree of reassurance that their lives will be better because of the new InSync ICD system. Fear of sudden death or diminished quality of life can be replaced with quiet confidence of a better future."
Heart failure affects about 22.5 million persons worldwide, with about 2 million new cases diagnosed each year. About 6.6 million Europeans are victims, with approximately 590,000 new cases diagnosed each year. About a third of all heart failure patients are candidates for resynchronization therapy, and a substantial portion of these patients are at risk from ventricular tachyarrhythmias.
Mahle noted that, "The Medtronic InSync ICD was designed to expand Medtronic's leadership in heart failure management by
helping physicians care for patients with two common, yet clinically complex diseases. We designed our product to achieve resynchronization to treat heart failure while also monitoring the heart's electrical conduction patterns and delivering impulses designed to restore normal rhythms when accelerating patterns are detected.
"Clinical evaluation indicates that both objectives have been achieved. Preliminary indications of acceptance by the medical community are very satisfying."
The InSync ICD can deliver up to 34 joules of defibrillation energy and incorporates Medtronic Patient Alert(R), a proprietary feature that enables the product to automatically monitor its own performance and alert patients when physician attention is required. Device size is 66 cc. and estimated service life is 6.8 years.
The new system will be available immediately in Europe and Canada, as well as Hong Kong and Singapore in Asia. It is
currently under clinical investigation in the United States.
New Third-Generation Attain Left Ventricular Lead Released Outside U.S. Meanwhile, Medtronic also announced commercialization in the same markets of a third-generation product in its Attain family of leads designed to provide safe, effective options to the physician implanting resynchronization systems delivering impulses to
the left and right sides of the heart. The Attain Side-Wire Model 4191 is a 4.1-French lead delivered with a guidewire and/or stylet, and employs an international-standard connector. The diameter is about the size of the wire in a large paperclip. Comments from European clinical investigators have endorsed its design as being particularly appropriate for patients with small, complex venous anatomies.
Dr. Vince Paul, Department of Cardiology, Royal Brompton and Harefield NHS Trust, Uxbridge, U.K., said the growing
selection of left ventricular leads is critical to successful system implantation. "Each patient is different, and a separate approach to the left ventricle must be planned for each," he said. "This range of choice is critical for successful implantation in difficult
venous anatomies and the ultimate effectiveness of the system."
In addition to the new Attain Side-Wire lead, the Medtronic leads "toolkit," which has helped physicians achieve implantation success in 94 percent of patients involved in one resynchronization study, includes two leads released earlier. The Attain CS (Coronary Sinus) Lead Model 2188 is a 6.2-French bipolar lead designed to carry resynchronization impulses to the left side of the heart. The unique canted electrode design is particularly suited for large venous anatomies. The Attain LV (LeftVentricular) Lead Model 2187 also 6.2 French in diameter, but tapering to a 5 French curved electrode tip, is designed for accessing the left ventricle via a guiding catheter and stylet. The Attain LV Model 2187 is the gold standard for left ventricular
leads with well over 2,000 implants to date.
Medtronic's leads are equipped with the IS-1 or DF-1 standard connectors that allow universal connection to stimulation devices without the need for bulky adaptors.
Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is medtronic.com .
Any statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in the company's Annual Report and on Form 10-K for the year ended April 30, 2000. Actual results may differ materially from anticipated results.
SOURCE: Medtronic, Inc.
CONTACT: Kevin Lee, Investor Relations, 763-514-7750, or Diana Campau, Media Relations, 763-514-4920, both of Medtronic, Inc. |
