Guidant receives FDA approval to re-enter heart failure market

Aug 2 2005

Guidant Corporation has announced U.S. Food and Drug Administration (FDA) approval to re-launch its CONTAK RENEWAL 3 family of cardiac resynchronization therapy (CRT) defibrillators in the United States. The company expects to resume worldwide distribution and implants of its CRT defibrillators by mid-week. Guidant expects full product supply within this month.

“Our top priority is to provide safe, reliable cardiac rhythm management products and therapies to physicians and patients,” said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. “Guidant's return to the CRT defibrillator market is exceptionally important for patients with heart disease. It is the result of sound engineering, unwavering dedication to highest product quality, and FDA’s timely response to validated technical information and analysis.”

As reported last week, Guidant received Conformité Européenne (CE) Mark approval to re-launch CONTAK RENEWAL 4 cardiac resynchronization therapy defibrillators for use outside the United States. The combination of these regulatory approvals clears the way for Guidant to once again fully participate in the fastest growth area within cardiac rhythm management – cardiac resynchronization therapy defibrillators.

Guidant had voluntarily removed these devices from implant and distribution on June 24, 2005, after identifying device performance and potential safety concerns related to a magnetic switch component. No additional reports of this component failure have been received since that time. After further testing and evaluation of the CONTAK RENEWAL 3 and 4 cardiac resynchronization therapy defibrillators, the company has identified, and the FDA has approved, a new component solution that resolves these concerns. Guidant previously provided physicians with a programming recommendation for CONTAK RENEWAL 3 and 4 cardiac resynchronization therapy defibrillators already in service. In addition, Guidant has received approval for United States distribution of new software designed to help physicians better manage existing RENEWAL 3 patients. The new software will be available outside the United States later this year.

A cardiac resynchronization therapy defibrillator delivers small electrical impulses to both ventricles that may improve the heart’s pumping ability. The device also monitors the heart for potentially fatal heart rhythms that can cause sudden cardiac death and, if such a rhythm is detected, delivers a lifesaving shock to restore normal heart rhythm.