Abbott Obtains FDA Approval for HeartMate 3 Device

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Abbott announced on October 19, 2018 that its HeartMate 3 Left Ventricular Assist Device (LVAD) has received U.S. Food and Drug Administration (FDA) approval as a destination therapy for people living with advanced heart failure. Physicians now can offer the HeartMate 3 system to patients not eligible for a transplant. The HeartMate 3 LVAD can serve as a permanent implant, allowing patients to live with the device for the rest of their lives.

The MOMENTUM 3 study, which included more than 1,000 patients with New York Heart Association (NYHA) Class IIIB or IV heart failure and which followed patients for a short-term endpoint of six months and a long-term endpoint of two years, supported HeartMate 3’s FDA approval. It was reported that during the study, patients with the HeartMate 3 LVAD had a survival rate of 82.8 percent at two years. It was also reported that the rate of suspected pump thrombosis (clotting of blood) remained low, at 1.1 percent, at two years and that the stroke rate was low, at 10 percent, at two years.

According to Abbott, the HeartMate 3 uses magnetic levitation technology. This technology has been designed to reduce trauma to the blood passing through the pump.

Shuchen Gong
Shuchen Gong is an associate in our San Francisco Office. Her practice focuses on the preparation and prosecution of patent applications. Shuchen received her law degree from Cornell Law School and her B.S. in Chemistry and B.A. in Economics from the University of California, Berkeley. Shuchen joined the firm in 2017.
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