Biotronik Receives FDA Approval for Entovis Pacemaker System

Biotronik SE & Co. KG has gained U.S. Food and Drug Administration (FDA) approval for its Entovis pacemaker system with ProMRI technology.

The device allows patients to undergo magnetic resonance imaging (MRI) scans with a limited exclusion zone. This latest approval covers both single and dual chamber Entovis pacemakers when implanted with Setrox pacing leads.

Biotronik claims to be the first company in the United States to offer both single and dual-chamber pacemakers approved for use in an MRI environment.

The FDA has approved the product only 16 months after the initial clinical study was launched, and five months after the approval of that study’s expansion to include full-body MRI scans.

FDA approval is based on these studies, which are designed for product evaluation and to assess the safety and efficacy of Biotronik’s existing single and dual-chamber Entovis pacemaker systems and Setrox 53 and 60 cm leads during MRI scans.

These devices in the study are commercially available, but lacked FDA approval for use in the MRI environment.

Every year in the United States, more than 50,000 people are implanted with single-chamber pacemakers, and until now, these patients have not been able to access MRI scans.

According to the company, Setrox, including versions released under other names, is the most used lead in MRI pacemakers currently on the market with more than 850,000 leads sold worldwide.

The Setrox active-fixation pacing leads have a flexible distal end, fractal coating, and steroid elution to ensure reliable handling and stable fixation, as well as optimal electrical performance.

“With the Entovis longevity and the history of lead reliability, this is a system that will serve a wide variety of pacemaker patients for the foreseeable, and unforeseen, future needs,” said Carleton Nibley, M.D., an electrophysiologist at John Muir Medical Center in Concord and Walnut Creek, Calif., who participated in the ProMRI study.

Entovis patients need only to alert radiology staff and they will verify that they are eligible to undergo the imaging. The company believes that this is a significant advantage over MRI-conditional pacers.

Globally, several million patients currently are implanted with pacemaker systems, and recent studies estimate that a sizeable portion of them will develop a clinical need for an MRI scan during their lifetimes.

Entovis devices include Biotronik Home Monitoring technology, which provides daily monitoring of the patient’s device, and offer the most advanced physiological therapy available via closed loop stimulation.

According to GlobalData estimates, the U.S. implantable cardiac devices market was valued at $1.94 billion in 2012, and is expected to grow at a compound annual growth rate of 2.5 percent to reach $2.3 billion by 2019.