FDAnews Device Daily Bulletin


April 14, 2006

The FDA has approved and the first implant was completed of the newest Biotronik Implantable Cardioverter Defibrillator (ICD) lead, the Linox SD active fixation, steroid-eluting lead.

The Linox SD incorporates a slim lead body, an advanced helix mechanism, and two color-coded DF-1 connectors. Linox SD also features fractal technology for improved sensing performance and a steroid-eluting collar to control acute threshold increases.

The first U.S. implantation of Linox SD was performed at Riverview Regional Medical Center in Gadsden, Ala. B.J. Patel, the physician who performed the first surgery, said he was very pleased with the agility and handling characteristics of this new lead, as well as its low threshold numbers.

"Biotronik's Linox SD easily went through an 8F introducer, and its helix is clearly visible under the fluoroscope. It is definitely one of the best performing ICD leads on the market," Patel said in a statement.

The company also recently received FDA approval for the Setrox S active fixation, steroid-eluting bradycardia lead. Both Linox SD and Setrox S offer great mapping capability that allows physicians to identify the optimal implant location prior to extension of the helix.