FDAnews Device Daily Bulletin

Sorin Gets FDA Approval for Smallest Dual-Chamber Pacemaker

Aug. 8, 2008

The FDA has approved the Sorin Group’s Reply family of dual- and single-chamber pacemakers.

In sinus node disease and unselected AV block patients, the pacemakers have been shown to reduce unnecessary pacing, which can lead to the development of heart failure and atrial fibrillation. The devices also have a feature for automating follow-up tests.

At 8 cc, the dual-chamber pacemaker is the smallest in the world, Sorin said.