FDA approves less-invasive approach for heart pump implantation
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Abbott announced that an alternative, less-invasive surgical technique for the implantation of a left ventricular assist device has been approved by the FDA.
The approved surgical approach involves implantation of an LVAD (HeartMate 3) via lateral thoracotomy, which may lead to less bleeding and a shorter recovery time. This also may result in fewer open-heart surgeries for patients with advanced HF, according to a press release from the company.
“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,” Igor Gosev, MD, a heart transplant surgeon at University of Rochester Medical Center in New York, said in the release. “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 to opportunity to return to a better quality of life more quickly.”
Approval of the surgical approach was based on findings from the ELEVATE and the LAT Feasibility trials. Both trials found that patients who received the heart pump with the less-invasive approach had lower rates of infection, bleeding requiring surgery and arrhythmias compared with those who underwent open-heart surgery, according to the release.
“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 2 years that are comparable to heart transplants,” Robert L. Kormos, MD, medical director for mechanism circulatory support at Abbott, said in the release.
Disclosures: Kormos is an employee of Abbott. Gosev reports he has a contract with Abbott for educational purposes only and does not receive compensation for media or marketing activity.