FDAnews Device Daily Bulletin

GUIDANT RECEIVES EUROPEAN APPROVAL FOR HEART LEAD

Dec. 14, 2005
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European regulators have approved Guidant's new Acuity Steerable heart-failure lead, the company announced.

The firm received the European CE Mark for the left ventricular lead device, which is designed to help physicians perform fast and predictable implants. Leads are insulated wires that connect an implanted cardiac device to the heart.

Since Guidant introduced bipolar left ventricular (LV) leads in Europe in 2002, physicians have quickly adopted the technology, the company said. Roughly 90 percent of procedures involving a cardiac resynchronization therapy product from Guidant's Renewal family of devices now also include bipolar leads, the firm said.

"Delivery of the LV lead where you prescribe it, and not where you can get it, is one of the most critical aspects of any cardiac resynchronization therapy system implant," said Stephen Mester of the Tampa, Fla., General Hospital, who served as principal investigator for the Acuity Steerable clinical trial.

Guidant expects to launch the Acuity Steerable lead in the U.S. in 2006, pending FDA approval.