received Food and Drug Administration approval to reintroduce a line of heart devices that the company had pulled from the market earlier this summer.
The FDA decision covers Contak Renewal 3 cardiac resynchronization therapy defibrillators. The company expects to resume worldwide distribution and implants of its CRT defibrillators by the middle of the week.
"Our top priority is to provide safe, reliable cardiac rhythm management products and therapies to physicians and patients," said Fred McCoy, president of cardiac rhythm management at Guidant. "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."
Last week, the Indianapolis-based medical devices maker received European regulatory approval to restart sales of the Contak Renewal 4 defibrillator for use outside the U.S. With the approvals, the company, which is in the process of being acquired by
Johnson & Johnson
, can resume sales of its products in the fastest growth area within cardiac rhythm management -- CRT defibrillators.
Guidant had voluntarily removed the devices from the market in June after identifying performance and potential safety concerns related to a magnetic switch component. After further testing the company gained approval for a new component that resolves the matter. In addition, Guidant received U.S. clearance to distribute new software that's designed to help doctors better manage existing Renewal 3 patients. The new software will be available outside the U.S. later this year.
A cardiac resynchronization therapy defibrillator delivers small electrical impulses to both ventricles of the heart in order to improve its pumping ability. The device also monitors the heart for potentially fatal rhythms that can cause sudden cardiac death.