St. Jude's new dual-chamber pacemaker gets CE Mark

St. Jude Medical Inc. (St. Paul, MN) has received CE Marking for its new Integrity Micro AutoCapture Pacing System allowing it to be sold in all countries in the European Union.

The dual-chamber pacemaker is a greatly downsized addition to the St. Jude Medical Integrity AFx family of pacemakers that was released earlier this year.

The device has also been implanted in its first patient. On November 27, Prof. Dr. Karl-Heinz Kuck implanted the pacing system in a 77-year old male patient with first-degree AV block and sinus node dysfunction at Allgemeines Krankenhaus St. Georg Hospital, Hamburg, Germany. The procedure lasted just over thirty minutes. The patient is doing well and the device is functioning properly.

The device is available in both dual-chamber rate-responsive (DR Model 5336) and single-chamber rate-responsive versions (SR Model 5136). The Integrity Micro DR (Model 5336) AutoCapture Pacing System is approximately 30% downsized from the dual-chamber Integrity AFx Model 5346 pacemaker and is the smallest dual-chamber pacemaker available.

The Integrity Micro pacemaker is the sixth St. Jude Medical device to feature the clinically proven AutoCapture Pacing System. Designed to ensure patient safety, improve patient management and optimize device longevity, the proprietary pacing system monitors for capture on a beat-by-beat basis and provides a high output back-up safety pulse in the event of non-capture-all the while continuously and automatically adapting output slightly above the patient's threshold. By delivering the lowest possible energy output required to stimulate the heart, the Integrity Micro AutoCapture Pacing System (DR Model 5336) is able to yield a projected longevity of greater than six years.

Edited by Ursula Jones
Managing Editor, Medical Design Online