

Cardiac rhythm management giants Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT) both notched regulatory wins this week, 1 in the U.S. and another across the pond.
St. Paul, Minn.-based pure-play med-tech titan Medtronic won an expanded indication for its line of implantable cardioverter defibrillator devices, allowing it to market the devices for mildly symptomatic heart failure.
That opens up Medtronic’s CRT-D devices to some 200,000 additional U.S. patients who fit the New York Heart Assn.’s Class II heart failure designation, according to a press release.
The new clearance relied on results from the company’s Reverse and Raft clinical trials, which showed that "CRT-D can benefit mildly symptomatic heart failure patients by reducing mortality and heart failure hospitalization rates," Medtronic reported.
Natick, Mass.-based CRM rival Boston Scientific notched its own win this week, landing CE Mark approval in the European Union for its Ingenio line of pacemakers.
The next-generation pacers with RightRate technology are designed to treat a condition known as chronotropic incompetence, the inability of the heart to regulate its rate in response to physical activity.
"The Ingenio family of pacemakers represents a significant investment in long-term innovation for pacing technologies and defines a new era of pacing for our company," CRM group president Joe Fitzgerald said in prepared remarks. "In addition, we expect to launch a series of devices with expanded capabilities, that would include remote monitoring, advanced heart failure diagnostics and compatibility with magnetic resonance imaging systems – all designed to provide innovative new features for patient health and well-being."
The Ingenio devices, which are compatible with Boston Scientific’s remote patient management systems, are currently under review at the FDA, according to a press release.