FDA approves next-generation Medtronic pacemaker

Medtronic ($MDT) snagged FDA approval for its next-generation cardiac resynchronization therapy (CRT) pacemaker in patients with heart failure, expanding its cardiovascular portfolio and advancing its proprietary technology for heart rhythm therapy.

The Minneapolis-based company won the agency’s blessing for its Viva CRT-P device with the AdaptivCRT algorithm, an innovative feature that reads and automatically adjusts to patients’ heart rhythms. Data from a recent trial of the device showed that the technology reduced 30-day hospital readmission for heart failure by 47% and reduced the risk of atrial fibrillation when compared with traditional biventricular therapy, the company said in a statement. The device is already CE marked and available for use in Europe.

“Our aim is to help people living with heart failure by making cardiac resynchronization therapy even better, through research and improved therapies,” David Steinhaus, medical director for Medtronic’s Cardiac Rhythm and Heart Failure Management unit said in a statement. “The addition of Viva CRT-P to our U.S. portfolio reinforces our commitment to making CRT treatment even more powerful by improving care for patients, reducing complications and ultimately reducing costs.”

FDA approval for its Viva CRT-P device bodes well for Medtronic as the company continues to chart gains at home and abroad. The med tech giant exceeded Wall Street’s estimates with $4.3 billion in revenue during Q1 2014 and posted a 3% increase for its Cardiac and Vascular Group, its bread-and-butter business.

Viva CRT-P is not the only product Medtronic boasts in its arsenal. Earlier this year, the company won an FDA OK for a fleet of pacemakers and defibrillators in patients with less severe heart failure and successfully implanted its tiny cardiac pacemaker in its first patients as part of a global clinical trial.

Meanwhile, Medtronic faces competition from other med tech heavyweights looking to cash in on the cardiac rhythm market. In March, St. Jude Medical ($STJ) bagged FDA approval for its Allure Quadra cardiac resynchronization therapy pacemaker to treat patients with heart failure. In May, Biotronik scored an FDA OK for its MRI-compatible Eluna pacemaker, an implantable cardiac device with home monitoring technology that allows physicians to observe patients’ heart rate daily.

Published on FierceMedicalDevices

August 26, 2014 | By Emily Wasserman


Share this post

Recent Posts