St. Jude Medical Gets CE Mark for Affinity Pacing System

St. Jude Medical Inc. has received approval for CE marking of the Pacesetter Affinity DR (dual-chamber) and Affinity SR (single-chamber) pacemakers and related software. The company is currently implanting devices and plans a full market release outside the United States during fourth quarter 1998.

The company submitted a PMA supplement for the devices and associated software to FDA on July 29, 1998, and anticipates U.S. commercial distribution of the devices during the first quarter of 1999.