Nov 11, 2003
Guidant Announces U.S. Approval and Market Release of Novel Defibrillation Lead Family
RELIANCE G Leads are First to Feature Covering to Prevent Tissue Ingrowth
Indianapolis, IN and St. Paul, MN - Guidant Corporation (NYSE: GDT), a world leader in the treatment of cardiac and vascular disease, today announced U.S. Food and Drug Administration (FDA) approval of the ENDOTAK RELIANCE® G family of defibrillation leads. This versatile product line features a proprietary covering to prevent tissue ingrowth into the defibrillation coils without compromising the electrical performance of the lead. It is the first defibrillation lead on the market to address tissue ingrowth using this unique approach. Preventing tissue ingrowth assists physicians with long-term management of implantable cardioverter defibrillator (ICD) patients.
Defibrillation leads are thin, insulated wires that connect an implantable defibrillator to the heart. The lead transmits signals from the heart to the defibrillator and, when appropriate, delivers therapy from the defibrillator back to the heart.
"Although rare, lead removal is sometimes necessary for a variety of reasons and it is impossible to know which patients may require such a procedure," said Dr. Larry Rosenthal, investigator in the ENDOTAK RELIANCE G U.S. clinical study at the University of Massachusetts Memorial Medical Center. "Removal is made even more difficult when tissue attaches to the lead. Guidant is the first company to offer a lead with covered coils that prevent tissue ingrowth, and I am pleased that the lead does not require compromise on handling or electrical performance."
"The new, innovative RELIANCE G leads add to Guidant''s impressive portfolio of implantable defibrillator systems," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "These leads offer our physician customers additional options for tailoring treatment to meet the specific needs of individual patients who require implantable defibrillator therapy."
Guidant anticipates that more than 120,000 patients in the U.S. will receive the lifesaving benefits of an ICD or cardiac resynchronization therapy - defibrillator implant in 2004.
Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of 11,000 employees, develops, manufactures and markets a broad array of products and services that enable less invasive care for some of life''s most threatening medical conditions. For more information visit www.guidant.com.
About the ENDOTAK RELIANCE G Family of Defibrillation Leads
Through an exclusive agreement with W.L. Gore & Associates, Guidant''s ENDOTAK RELIANCE G features a unique GORE(tm) covering to prevent tissue ingrowth into the defibrillation coils without compromising the electrical performance of the lead. GORE is a trademark of W. L. Gore & Associates.
The ENDOTAK RELIANCE G lead is built upon the proven ENDOTAK RELIANCE family, which includes a number of industry-leading features. These features include a smooth, thin (9 French) lead body with a unique coating for easier passage through introducers and tortuous anatomy; redundant layers of silicone insulation designed for increased reliability; and on the active-fixation models, easy-to-interpret fluoroscopic markers that enable clinicians to clearly see the operation of the helix-shaped tip. The ENDOTAK RELIANCE G family, like all of Guidant''s ENDOTAK RELIANCE leads, is backed by a limited lifetime warranty.
About Guidant''s Leadership in Tachyarrhythmia Therapy
Lifesaving tachyarrhythmia therapy is available as a result of Guidant''s continued commitment to clinical science and research, which has resulted in expanded implant indications, updated physician guidelines and a national reimbursement coverage decision for patients with a prior heart attack and low ejection fraction. The decisions were based on data derived from the Guidant sponsored Multi-Center Automatic Defibrillator Implantation Trial (MADIT) II.
On October 1, 2003, the Centers for Medicare and Medicaid Services (CMS) expanded national coverage for the use of implantable defibrillators for patients with a previous heart attack, left ventricular ejection fraction ≤30%, and QRS duration greater than 120 milliseconds. This decision increases the number of people who will receive the lifesaving benefits of ICDs.