The FDA approved a new, less invasive surgical technique for the placement of Abbott’s best-selling heart pump, allowing patients to avoid open surgery.
The HeartMate 3 left ventricular assist device (LVAD) can now be implanted through an incision in the chest wall and between a patient’s ribs in what’s known as a lateral thoracotomy. A single-arm clinical trial found rates of excessive bleeding, infection and arrhythmias were lower using the new method.
Abbott says this alternative will let more patients with advanced heart failure receive an LVAD, such as those who might not be strong candidates for an open heart procedure, as well as offer less bleeding and a shorter recovery time.
The HeartMate 3 first received FDA approval in 2017 as a bridge therapy for patients awaiting a heart transplant. The next year, the small internal pump was approved as a destination therapy for people who need a new heart but are not eligible for a transplant. It was the first approved with magnetic technology that suspends the pump’s rotor within the device, with the goal of reducing trauma to blood as it moves through the pump.
"The first approved LVAD—HeartMate I—was approved more than 25 years ago. Since that time, the technology has evolved immensely,” said Robert Kormos, medical director for mechanical circulatory support at Abbott.
“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," Kormos said.
In MOMENTUM 3, described as the largest LVAD trial in the world, HeartMate 3 demonstrated a survival rate of 82.8% after two years.