FDA Clears Sylmar Firm to Market New Pacemaker

Pacesetter Systems in Sylmar said the U.S. Food and Drug Administration cleared its plans to market a new dual-chamber pacemaker called the Paragon.

A pacemaker, which is implanted near the heart, is an electronic device that stimulates the heart muscles to restore a normal heartbeat to the patient. A dual-chamber pacemaker paces the heartbeat in the upper and lower chambers of the heart, and Pacesetter said half of the 100,000 people who need pacemakers each year require this type of device.

Pacesetter, a unit of Siemens AG of West Germany, said the Paragon weighs 1.5 ounces and should last up to seven years. Its wholesale cost to doctors and hospitals is about $4,500.