HeartMate 3 is a CE Mark and FDA approved commercial Left Ventricular Assist Device (LVAD), and uses Full MagLev technology to improve outcomes for patients
FDA approves Abbott’s new less invasive surgical approach for HeartMate 3 LVAD. (Credit: Pixabay/skeeze).
US-based medical devices company Abbott has received the US Food and Drug Administration (FDA) approval of a new alternative surgical technique for its HeartMate 3 Left Ventricular Assist Device (LVAD).
The company said that its HeartMate 3 LVAD is a small, implantable mechanical circulatory support device, designed for advanced heart failure patients requiring transplantation.
The device is said to be the first CE Mark and FDA approved commercial LVAD, and uses Full MagLev technology to reduce trauma to blood passing through the pump and improve outcomes for patients.
Abbott mechanical circulatory support medical director Robert L Kormos said: “We continue to focus on advancing our heart failure devices and techniques to make life better for the patients we serve. The first approved LVAD HeartMate. It 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.”
Abbott’s alternative surgical technique lowers bleeding, infection and arrhythmias
The company said that the new surgical technique will help the heart failure patients by preventing open heart surgery, and enables surgeons to choose the surgical method using its HeartMate 3 LVAD.
Traditional heart pumps are implanted through open-heart surgery. Through the alternative surgical technique, HeartMate 3 heart pump can be implanted through lateral thoracotomy, a surgical approach to access the heart through an incision between ribs.
The new less invasive surgical technique is thought to be more effective than open heart surgery, resulting in less bleeding and shorter recovery time for many patients.
Abbott said that the regulatory approval is supported by the clinical trials ELEVATE, and the LAT Feasibility study. According to the results of the clinical studies, the less-invasive surgical approach demonstrated lower bleeding, infection and arrhythmias in patients, compared to open-heart surgery.
University of Rochester Medical Centre’s heart transplant surgeon Igor Gosev said: “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.
“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.”