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| Biotronik's Entovis pacemaker system--Courtesy of Biotronik |
Biotronik scored FDA approval for its next-generation, MRI-safe pacemaker system, continuing its winning streak for its implantable cardiac devices.
The Entovis pacemaker system includes both single-chamber (SR-T) and dual-chamber (DR-T) devices implanted with Setrox pacing leads, making Biotronik the first company in the U.S. to offer both single- and dual-chamber pacemakers approved for use in an MRI environment, the company said in a statement. The devices also include Biotronik's home monitoring technology, which allows physicians to observe patients' heart activity daily.
"The Biotronik Entovis ProMRI pacemaker system is the latest example of our commitment to excellence and meaningful innovation in supporting patient treatment and quality of life," Paul Woodstock, Biotronik's executive vice president of sales and marketing, said in a release. "We are proud to be able to satisfy the demand for state-of-the-art devices that allow physicians to deliver optimal care to the increasing number of pacemaker patients who may someday need an MRI."
The regulatory OK comes just weeks after the FDA allowed Biotronik to expand its ProMRI trial to implantable cardioverter-defibrillators, making it the first company in the U.S. to test whether an ICD could safely undergo an MRI. Biotronik performed initial ICD surgeries for the studies at hospitals in the U.S. in April, testing its Iforia devices with Setrox and Linoxsmart leads during MRI scans. The German company had already received a regulatory go-ahead in January to study its ProMRI technology in 245 pacemaker patients and secured a CE mark for its device in Europe last year.
FDA approval for its MRI-safe pacemakers helps Biotronik compete in a saturated cardiac implant market. Rivals Medtronic ($MDT), Boston Scientific ($BSX) and St. Jude ($STJ) are working on securing approvals for their own devices and are pushing for sales of their defibrillators at home and abroad. In June 2013, St. Jude won Japanese approval for its MRI-friendly pacemaker and lead, and Medtronic has its Revo MRI-safe pacemaker cleared for use in the U.S. Not to be outdone, Boston Scientific is hard at work on its cardiac rhythm management system and recently won FDA approval for its mini ICD devices.
- read the release