First Implants of St. Jude Medical's Affinity Pacing System Complete

St. Jude Medical Inc. announced that the first implants of its Pacesetter Affinity DR took place at two Swiss hospitals on August 12, 1998. According to the company, the Affinity DR is the world's smallest dual-chamber rate-responsive pacemaker.

The Pacesetter AutoCapture pacing system combines beat-by-beat capture confirmation with a back-up safety pulse, enabling the pacemaker to continually monitor the heart's response to electrical stimulation and to promote an uninterrupted heartbeat.

The company also submitted a SPMA (supplemental premarket approval application) to FDA, seeking approval for commercial distribution of the Affinity DR and Affinity SR (single-chamber) devices and associated software in the United States. European market release of the first Affinity pacing systems is expected later this year.