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Abbott Laboratories has won a nod from FDA for a new alternative surgical technique for the HeartMate 3 Left Ventricular Assist Device (LVAD). This technique will not only allow more advanced heart failure patients the opportunity to avoid open-heart surgery, but it will help advance the firm's position in the LVAD market.
Dublin-based Medtronic won the same designation for the HVAD in 2018. Abbott said the HeartMate 3 heart pump can now be implanted through an incision in the chest wall.
The new FDA nod for HeartMate 3 is based on two studies – the ELEVATE study: a multi-center, voluntary, observational registry collecting post-marketing data, and the LAT Feasibility study: a single-arm, prospective, multicenter study. Results of the two trials found that bleeding (requiring surgery), infection and arrhythmias were lower in the group implanted via the less-invasive surgical approach than those who underwent open-heart surgery.
"We continue to focus on advancing our heart failure devices and techniques to make life better for the patients we serve," Robert L. Kormos, M.D., medical director for mechanical circulatory support at Abbott, said in a release. "The first approved LVAD—HeartMate I—was approved more than 25 years ago. Since that time, the technology has evolved immensely. Today's HeartMate 3 device, including its design and size, allows physicians to successfully implant it without having to perform open-heart surgery and offers survival rates, as demonstrated in the MOMENTUM 3 clinical trial, at two-years that are comparable to heart transplants."
HeartMate 3 first won a nod from FDA in 2017 for patients with advanced heart failure whose hearts are unable to circulate blood through the body, and are waiting for a transplant, known as bridge to transplant. Back in 2018, HeartMate 3 was approved as a destination therapy for those individuals who need new heart but aren’t eligible for a transplant.
Abbott inherited the HeartMate 3 technology through its $25 billion acquisition of St. Jude Medical. In turn, the St. Paul, MN-based company obtained HeartMate through its acquisition of Thoratec, in 2015, for $3.4 billion.