First implants of Medtronic Adapta pacemaker for slow heart rhythm

6 July 2005

Minneapolis, USA. Medtronic, Inc. has started clinical studies to evaluate its Adapta pacemaker in Serbia, Germany and Austria. The Adapta promotes natural heart activity for patients with a slow heart rhythm. Within the next year, Medtronic expects to introduce a portfolio of fully automatic pacemakers, the Adapta, Versa, and Sensia, in countries worldwide. These pacing systems are designed to provide physiologic pacing adapted to the needs of individual patients.

The first Adapta pacemaker implants were conducted by Associate Professor Goran Milasinovic, M.D., Ph.D., Clinical Center of Serbia, Belgrade; Johannes Sperzel, M.D., Kerckhoff-Klinik in Bad Nauheim, Germany; and Professor Karlheinz Tscheliessnigg, M.D., at Universitatsklinikum Graz, in Graz, Austria. The clinical study is a prospective, non-randomized, multicenter trial, involving up to 120 patients at 10 sites, to evaluate the safety and clinical performance of the Adapta pacing system.

The Adapta pacemaker offers the Medtronic-exclusive pacing mode called MVP(TM) or Managed Ventricular Pacing, which enables the device to be programmed to deliver pacing pulses to the heart's lower right chamber (ventricle) only when necessary, often less than 2 percent of the time. Other dual-chamber pacemakers often pace the right ventricle 90 percent or more of the time. Recent clinical studies have suggested that reducing this pacing stimulation may reduce the patient's risk of developing heart failure and atrial fibrillation, a potentially life-threatening irregular heartbeat.

"By reducing unwarranted ventricular pacing, we hope to reduce incidences of heart failure hospitalization," said Associate Professor Milasinovic, coordinating clinical investigator of the evaluation. "The Adapta's therapeutic features may enable physicians to better manage the co-morbidities that typically befall bradycardia patients."

The new pacemaker systems also incorporate an array of automatic features designed to help physicians improve pacing therapy and streamline the patient follow-up process, potentially minimizing the amount of time spent in a physician's office.

"We continue to aggressively research, develop and test new algorithms and therapy delivery techniques," said Steve Mahle, president, Medtronic Cardiac Rhythm Management. "We have applied physiologic pacing features to each of the products in the Adapta portfolio to potentially prevent disease progression."

Cautionary note from the company: The Adapta pacemaker is an investigational device. The device is limited by federal (or United States) law to investigational use only. It is not available for sale in the United States.

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