Texas-based ReliantHeart is hoping to make some inroads in the U.S. with new study data touting its HeartAssist5 as a safer option compared with Thoratec’s (NSDQ:THOR) HeartMate II left ventricular assist device.
The report comes at a time when Thoratec is already facing significant backlash over blot clot risk associated with its HeartMate II. The company is the target of a shareholder lawsuit and a prominent journal article warning of the potential for patient harm, as well as a high-risk recall following a handful of patient deaths and injuries.
ReliantHeart this week touted a newly published study comparing its HeartAssist5 to the HeartMate II in advanced simulation testing, reporting that the HeartAssist5 was deemed a lower risk of causing blood clots and blood damage.
The HeartAssist5 implant features "device thrombogenicity emulation," a design methodology aimed at reducing the potential for forming blood clots. Devices that are designed to avoid spurring clots could allow patients to reduce or eliminate their reliance on blood thinners, researchers wrote.
"Based on the present study, the HA5 offers not only an anatomical advantage because of its smaller dimension, but better thromboresistance, which may clinically translate into a significant reduction of the mandatory anticoagulation/antithrombotic drug regimen as compared to an FDA-approved VAD device which was not optimized with the DTE methodology as the HA5 was," according to the study.
ReliantHeart calls its HeartAssist5 the "smallest and lightest full support LVAD in the world, weighing only 92 grams." The device is nearly silent, and its tiny size allows implantation beside the heart. The company plans to enter the U.S. market through an FDA investigational device exemption, which would permit the company to move forward with human trials, according to a press release.
VAD devices are used to support blood circulation in patients with heart failure. Most devices on the market were approved as a so-called "bridge-to-transplant" device, but the scarcity of available donor organs inspired the FDA in 2010 to grant approval for Thoratec’s HeartMate II as a "destination" device.
The HeartAssist5 device has CE Mark approval in the European Union but has yet to reach the U.S. market, where Thoratec’s HeartMate II is under fire from researchers, shareholders and regulators.
The FDA just last week gave its highest-risk Class I label to Thoratec’s HeartMate II recall after 5 patient injuries and 4 deaths were reportedly associated with defects in the pumps’ controllers. The device is also the subject of a shareholder lawsuit spurred by a 2013 New England Journal of Medicine study that highlighted the risk of blood clots associated with the HeartMate II.
The NEJM article reported a sharp increase in rates of blood clots in patients implanted with the HeartMate II, using data from 3 centers that implanted more than 830 of the devices from January 2004 through May 2013. The data showed a total of 72 confirmed cases of pump thrombosis in 66 patients and another 36 cases of suspected pump thrombosis. The study also revealed a sharp decrease in the amount of time from implantation with the HeartMate II device until blood clots developed.
Earlier this year Thoratec CEO Gary Burbach said the NEJM study, involving by then year-old data from only 3 centers, obscured the fact that adverse events associated with the HeartMate II are down.
"The broader context is that survival has actually improved since the clinical trial, quite significantly here in the commercial experience," Burbach said at the J.P. Morgan healthcare conference in San Francisco. "We’ve also seen significant improvements in other areas – adverse events, stroke, bleeding and infection, in particular."
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