Medtronic wins FDA nod for app-based remote pacer monitor

Medtronic (NYSE:MDT) said today it won FDA premarket approval for its app-based MyCareLink Smart Monitor remote monitoring system for patients with implanted pacemakers.

The Fridley, Minn.-based medical giant said the newly-cleared monitoring system is the world’s 1st app-based pacemaker remote monitor. The system allows patients to transmit data from their Medtronic pacers to physicians who can analyze the data to make treatment decisions.

“The use of smart technology continues to grow among people of all ages, and especially among people over 65 which is the age range of the majority of our pacemaker patients. As a leader in remote cardiac monitoring, Medtronic is committed to providing cardiac patients with the latest technology to improve their health and make their lives easier, while helping to reduce the costs of healthcare. The MyCareLink Smart Monitor is just the 1st of many innovative solutions we are developing that leverage smart technology to increase patient engagement,” cardiac and vascular connected care biz GM Darrell Johnson said in prepared remarks.

The MyCareLink Smart Monitor includes a handheld portable device reader and the MyCareLink Smart mobile app, which runs on both Apple (NSDQ:AAPL) iOS and Google (NSDQ:GOOG) Android devices, Medtronic said.

“Remote monitoring of pacemakers and other cardiac devices is now the standard of care, as studies have established how it benefits patients – including faster diagnoses and increased survival – as well as how it helps physicians manage their pacemaker patients through increased efficiency and convenience. Because the MyCareLink Smart Monitor is integrated into existing mobile platforms like smartphones and tablets, it is easy for patients to transmit data from their pacemakers to their doctors via the technology that they are using every day. This innovation will serve as the foundation for future advances using smart technology to support cardiac patients,” Dr. George Crossley III of Nashville, Tenn.’s Vanderbilt Heart and Vascular Institution said in a press release.

Earlier this month, Medtronic’s entry into the micro-sized leadless pacemaker market met its primary safety and effectiveness endpoints with “wide margins,” the company said.

The Micra transcatheter pacing system, which at 1/10th the size of a conventional pacemaker is roughly the size of a large vitamin, is designed to be implanted via catheter in the right ventricle to deliver single-chamber pacing, Medtronic said. The Micra device has an estimated 12-year battery life and is approved as safe for full-body MRI scans, the company said.

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