The Food and Drug Administration has approved Medtronic’s left ventricular assist device for use in advanced heart failure patients who need help pumping blood around the body.
Medtronic, which is fighting Abbott for the LVAD market, claims its newly-approved HVAD System is the smallest commercially-available device of its kind. The design enables surgeons to implant the device via a small lateral incision, resulting in a less invasive procedure than is typical for LVADs.
The FDA approved the device based on data from a clinical trial of 144 end-stage heart failure patients. After six months, 88.1% of the patients were alive, free from disabling stroke and had functioning LVADs. That compared favorably to the prespecificed performance goal of 77.5%, resulting in the trial hitting its primary endpoint.
Medtronic moved into the LVAD sector in 2016 when it paid $1.1 billion to acquire Heartware, one of two big players in the space. The other big player, Thoratec, was bought for $3.4 billion in 2015 by St. Jude Medical, which, in turn, was acquired by Abbott. Medtronic valued the market at $800 million in 2016 and tipped it to achieve low-double-digit growth.
Abbott and Medtronic are both trying to improve outcomes in patients with advanced heart failure. After suffering from a heart attack or a condition such as cardiomyopathy, the left ventricles of these patients struggle to pump blood into the aorta and around the body. LVADs mitigate this weakness by serving as an artificial heart pump. As blood returns to the body, patients who were previously weak and breathless regain energy and a better quality of life.
Early versions of LVADs required patients to undergo open-heart surgery. Seeing the invasiveness of the procedure as a threat to patient outcomes, Heartware and later Medtronic worked on a different approach. The result is a LVAD designed to be delivered via a thoracotomy, a procedure that entails making a lateral incision between the patient’s ribs.
Medtronic gained clearance to sell its less-invasive LVAD in Europe through the CE mark process in 2016 and has now won FDA approval.
The U.S. approval gives Medtronic a new product to push as it competes for market share with Abbott, which is also working to bolster its offering. In March, Abbott presented clinical data linking its latest LVAD to a two-year event-free survival rate of 77.9%, an improvement of more than 20 percentage points over its previous model. The study also suggested Abbott’s HeartMate 3 LVAD is better at preventing strokes than Medtronic’s device, although caveats about the unreliability of cross-trial comparisons apply.
Medtronic’s one clear advantage is the size of its LVAD and the less-invasive delivery it enables. With the FDA approval secured, Medtronic can now work to make the most of that advantage