Abbot announced early Tuesday morning that the US FDA has granted approval for the HeartMate 3 device to be implanted via a lateral thoracotomy for patients with advanced heart failure.
In a move Abbott suggests will allow more advanced heart failure patients to avoid open-heart surgery, the US Food and Drug Administration (FDA) has granted approval of a new alternative surgical technique for Abbott’s HeartMate 3 Left Ventricular Assist Device, the company announced in a release.
The approval of the new, less invasive approach, which is based on the results of 2 studies, is the third approval for HeartMate 3—following previous approvals in 2017 for patients with advanced heart failure whose hearts are unable to circulate blood through the body awaiting transplant and in 2018 as a destination therapy for patients in need of a new heart but are ineligible for a transplant.
"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 Igor Gosev, MD, heart transplant surgeon at University of Rochester Medical Center. "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."
The alternative surgical technique approved by the FDA allows for the device to be implanted via a lateral thoracotomy. According to the release from Abbott, physicians believe this technique has advantages over open heart surgery for many patients because it can result in reduced bleeding and shorter recovery times.
The new approval, which allows surgeons a choice in surgical method for patients receiving the device, is based on data from the ELEVATE and LAT Feasibility study. ELEVATE, which was a multicenter voluntary, observational registry collecting post-marketing data, and the LAT Feasibility study, which was a single-arm, prospective, study, both indicated bleeding, infection, and arrhythmias were lower in patients implanted via the less invasive approach compared to patients undergoing open-heart surgery.
“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 Robert Kormos, MD, medical director for mechanical circulatory support at Abbott.