Abbott LVAD wins FDA approval for implantation without open heart surgery

Abbott (NYSE:ABT) today announced that FDA has approved implantation of its HeartMate 3 LVAD via lateral thoracotomy — a less invasive approach than open-heart surgery.
The approval comes about a year and a half after Medtronic (NYSE:MDT) won a similar approval for the competing HeartWare HVAD pump.
Lateral thoracotomy involves a surgeon making an incision between a person’s ribs to access the heart. The procedure results in less bleeding and shortened recovery time, according to Abbott.
“This is a significant advancement for patients who can now receive a life-saving LVAD through an alternative procedure that can yield shorter hospital stays and a faster recovery,” said heart transplant surgeon Dr. Igor Gosev of the University of Rochester Medical Center in Rochester, N.Y.
“Heart failure is a crippling and costly disease, so being able to offer patients the HeartMate 3 heart pump with this less-invasive approach gives them the opportunity to return to a better quality of life more quickly,” Gosev said in a news release
FDA approval came after two studies: Elevate, a multi-center, voluntary, observational registry collecting post-marketing data — and the LAT Feasibility single-arm, prospective, multicenter study. The two trials’ results showed that bleeding (requiring surgery), infection and arrhythmias were lower among people implanted with the LVAD through the less-invasive surgical approach versus open-heart surgery.
“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,” said Dr. Robert L. Kormos, medical director for mechanical circulatory support at Abbott.
FDA in 2017 approved HeartMate 3 as a “bridge to transplant” for advanced heart failure patients waiting for a transplant. A year later, the agency approved HeartMate 3 as a destination therapy for people who need a new heart but are not eligible for a transplant.
Original Article: (https://www.massdevice.com/abbott-lvad-wins-fda-approval-for-implantation-without-open-heart-surgery/)