At the American College of Cardiology meeting, Medtronic presents data from a trial that shows its CoreValve TAVR device has clinically better outcomes than surgically-replaced diseased heart valves.
At the 2014 American College of Cardiology meeting in San Francisco, analysts crowned Medtronic the clear winner in the race to dominate the transcatheter aortic valve replacement market. At least in the next year or two.
Edwards Lifesciences is the only other company with an FDA-approved, commercially available TAVR product int the market, although St. Jude Medical and Boston Scientific are developing their own devices. These devices are meant to treat patients with severe aortic stenosis, some of who cannot undergo open heart surgery.
Why has Medtronic and its CoreValve TAVR System taken center stage, even though Edwards introduced Sapien more than two years ago?
The data presented at ACC has some answers:
Medtronic also announced that the FDA has decided that it will not require a panel review of its high-risk arm data, which analysts took to mean that an expanded indication and approval from the FDA would come sooner than expected - possibly in the next six months.
All of this means only one thing - Medtronic will gain share in the marketplace at the cost of Edwards Lifesciences.
“We leave ACC even more convinced that the company will take greater US TAVR market share from Edwards over the next 12-18 months than the Street expects,” wrote Michael Weinstein, an analyst with JPMorgan Chase.
That thought was echoed by other analysts.
“We assume, that in the US, Medtronic takes 25.5% share in 2014, 31.8% in 2015, and 40.0% in 2016 (versus our previous estimates for 24.8%, 24.4%, and 30.2%),” wrote Joanne Wuensch, analyst with BMO Capital Markets.
Another analyst with Leerink Partners reported that physicians were impressed by the clinical data from CoreValve.
They “generally characterized the data as a ‘home run,’ " and expected to see their practices expand the use of the product in the next year or two than they initially projected, wrote Danielle Antalffy.
Over at RBC Capital Markets, analyst Glenn Novarro called Medtronic the “clear winner” and began adjusting his forecast for Edwards Lifesciences:
“Given strong High-Risk data and an earlier than expected regulatory pathway for MDT's expanded label, we are reducing our U.S. Sapien revenue forecast by ~$15 [million] to $328 [million] in 2014,” Novarro wrote in his latest research note.
Yet, all is not lost for Edwards Lifesciences as it battles Medtronic and soon-to-follow competitors like St. Jude Medical and Boston Scientific. In an European clinical trial that pitted its lower-profile Sapien XT device against Medtronic’s CoreValve, the California company came out on top.
Called CHOICE, the clinical trial involving 241 patients showed that “device success” was higher with Edwards’s Sapient XT than with Medtronic’s CoreValve.
“This result is important but should not be interpreted as a surrogate for long-term outcomes such as death, stroke, and quality of life,” said Dr. E. Murat Tuczu and Samir Kapadia in an editorial in the Journal of the American Medical Association published Sunday.
They reminded readers that Sapien and CoreValve were based on different technologies: Edwards’ Sapien is a “balloon-expandable (BE) valve … made of bovine pericardium mounted in a cylindrical, relatively short stent” while Medtronic’s CoreValve is “self-expanding (SE) valve made of porcine pericardium mounted in a taller, nitinol stent with an adaptive shape.”
The technologies are different, but the question of choice for physicians and patients - whether to use Edwards’ Sapien XT, which is not as yet approved in the U.S. or Medtronic’s CoreValve - has not been definitively answered.
“Continued efforts at understanding the risks and benefits of TAVR particularly in relation to patient characteristics and long-term outcomes are imperative for continued progress and refinement of these revolutionary devices. Additional rigorous randomized trials like the CHOICE trial will provide the quality of evidence necessary to ensure optimal use and optimal patient outcomes from TAVR.”
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