Oregon-based heart devices maker Biotronik touted FDA approval to expand its ProMRI clinical trials, permitting the company to enroll patients with implantable cardioverter defibrillators for full-body MRI scanning.
The trial marks the 1st time the FDA has allowed Biotronik to test its DX ICDs for MRI compatibility without requiring an "exclusion zone" around the implant, an important milestone for the company and the technology.
Biotronik has been pioneering MRI-safe cardiac implants since landing European approval in 2011 for what it calls the 1st ICD approved for use with MRI. The company earlier this month won FDA approval to market its Entovis pacemaker systems as MRI-safe with an exclusion zone, and the company hopes to win approval that would permit full-body scanning.
The ProMRI studies are "the next step in making this technology widely available in the U.S.," the company said.
"We are anxiously awaiting the day when this important diagnostic capability, up to now only available to pacemaker patients, can also benefit ICD patients," clinical studies vice president Kevin Mitchell said in prepared remarks. "We were the 1st company to offer ICD patients in the U.S. MRI access, and remain the only company that provides single-chamber pacemaker patients access to this diagnostic tool."
Biotronik is part of a short list of device makers with MRI-compatible devices on the market, competing with Minnesota medtech titan Medtronic (NYSE:MDT). Rival device makers Boston Scientific (NYSE:BSX) and St. Jude Medical (NYSE:STJ) are pursuing U.S. market approval for similar technologies.