FDA Approves Less Invasive Surgical Approach for Abbott’s Heart Pump, Heart Mate 3

Abbott HeartMate 3, Courtesy of Abbott

This week Abbott announced that the U.S. FDA has given approval of a new alternative surgical technique for their HeartMate 3 heart pump.

The procedure is designed to allow more advanced heart failure patients to avoid open heart surgery. The new, less invasive approach is designed to provide surgeons a choice in surgical method for patients receiving the HeartMate 3 Left Ventricular Assist device (LVAD), the industry’s leading heart pump.

Around 615,000 people in the U.S. are living with heat failure and nearly 40% are considered to have reached an advanced stage where traditional therapies are no longer effective. Heart pumps are small, implantable mechanical devices that pump blood through the body in replacement of a heart that is to weak to do so.

With approval for new alternative surgical techniques, Abbott’s HeartMate 3 heart pump can now be implanted via lateral thoracotomy. Consensus is that this procedure has advantages over traditional open-heart surgery because it can result in less bleeding and shorter recovery time for patients.

According to iData Research, with the maturity of VAD technology, many refinements and improvements have happened in design. These improvements have helped increase the efficacy and safety of these devices. Further technological improvements have made VADs more compact and easier to implant, which allow for approvals like this to be cleared to allow surgeons to perform these easier procedures.

Robert L. Kormos, M.D., medical director for mechanical circulatory support at Abbott, made a statement on the following,

“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 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.”

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For Further Information

To get in an in-depth market overview of 19 countries, with insight through primary research and procedural volumes, please read iData Research’s’ 2,145 page Cardiac Surgery Market Analysis, Size and Trends Report.