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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