Medtronic hunts for expanded pacer indication with large study
|Medtronic is launching a trial designed to expand the indication for CRT-P devices like Consulta--courtesy of Medtronic|
Medtronic ($MDT) has its eye on expanding the use of cardiac resynchronization therapy pacemakers (CRT-Ps), looking to test the devices in up to 2,300 patients with mildly reduced heart pumping function.
The company signed up its first patient in a 275-center study, and it plans to spend four to 5 years examining how CRT-Ps can help people with milder heart problems than the current FDA indication allows. The study, dubbed MIRACLE EF, is the first to test CRT devices in what Medtronic says is a widely underserved population, and David Steinhaus, the company's Cardiac Rhythm Disease Management medical director, said the trial presents a big opportunity for Medtronic.
"We are hopeful that, when completed, MIRACLE EF will influence clinical practice guidelines regarding the use of advanced cardiac resynchronization devices and potentially lead to another expanded indication for Medtronic CRT devices," Steinhaus said in a statement.
Medtronic plans to enroll patients across the U.S., Canada, Europe and Japan, and the company will track a composite endpoint of "time to first event," meaning all-cause mortality or heart failure hospitalization.
While a return to the FDA is years off (to say nothing of convincing payers and physicians to get behind implanting pacers in patients with mild ailments), an expanded indication for CRTs could pay off big for Medtronic's lagging cardiac business. While the Minnesota device giant hasn't endured a revenue plummet on the level of some of its competitors, Medtronic is facing single-digit shrinkage in CRM, making the prospect of a new, large patient population all the more attractive.
- read Medtronic's statement
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