CE Mark and EU Launch for Medtronic Viva® Cardiac Resynchronization Therapy-Pacemaker

Medtronic, Inc. has gained CE  Mark approval and will now launch its newest cardiac resynchronization therapy-pacemaker, Viva® CRT-P in Europe.

Background

Each year, cardiovascular disease causes more than 1.9 million deaths in the European Union. And the stats say that patients being hospitalized for repeated heart failure are associated with an increased mortality risk. To avoid the need for repeated hospitalization, patients with mild symptomatic, moderate or severe heart failure, as well as those with atrioventricular block who are expected to require a high degree of pacing and have a reduced ejection fraction can find themselves as candidates for CRT-P device implantation.

Medtronic says its CRT devices have been safely and effectively used for more than a decade to treat patients with heart failure. The company’s newly CE marked Viva CRT-P includes its exclusive AdaptivCRT® software, which is the only algorithm demonstrated to improve heart failure patients’ response to the therapy and reduce the risk of atrial fibrillation (as compared to conventional biventricular therapy). The AdaptivCRT algorithm works by preserving normal heart rhythms and automatically adjusting to the patient’s needs every minute, creating a customized therapy for each patient.

Independent studies have validated the benefits of the algorithm, including a 12 percent increase in CRT response rate, a 21 percent reduction in heart failure hospitalization and a reduced risk of death and a 46 percent reduced risk of AF.

Viva CRT-P also features advanced diagnostics tools, such as OptiVol® Fluid Status Monitoring and Cardiac Compass® Report, which provide unmatched levels of insight into patients’ physiological condition. These tools are proven to identify patients at risk for rehospitalization within 30 days of discharge, says the company.

Company comments

“The diagnostic capabilities of this smart device help improve function throughout the continuum of care,” said David Steinhaus, M.D., vice president and general manager, Heart Failure, and medical director for the Cardiac Rhythm Disease Management business at Medtronic. “This represents a win for both patients and physicians and, when coupled with additional longevity, provides another layer of distinct value over a longer period.”

Source: Medtronic, Inc.

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