Abbott received FDA approval for its HeartMate 3 left ventricular assist device (LVAD), a pump designed to augment cardiac output in patients with severe heart failure that are waiting for their heart to recover or that are in line for a transplant. Featuring the “Full MagLev”, as the technology is called by Abbott, the HeartMate 3 provides a wide passage for blood to flow through and does not create any friction in its mechanics thanks to a levitating self-centering rotor. This results in less shear damage to erythrocytes and thought to reduce changes of stroke and other complications. Additionally, the device pulses along with the ailing heart, a factor that may also be important in reducing the chances of emboli and clots.
The device is able to move up to 10 liters of blood per minute, but the actual energy comes from a driveline and battery system that’s worn sort of like a backpack. The system is programmable by a physician, including the amount of assistance to provide to the heart, but is not intended to be used for too long.
The HeartMate 2 is still indicated for longer term support when a heart transplant or an improved long term diagnosis is not expected.
Some details about the study that led to this approval, according to Abbott:
…patients who received a HeartMate 3 system had a significant improvement in their heart failure status, an 83 percent increase in their walk distance and a 68 percent improvement in quality of life at six months. Patients receiving HeartMate 3 also had an 86 percent survival rate with freedom from disabling stroke and reoperation to replace the pump at six months.
“In the MOMENTUM 3 study, the HeartMate 3 system had no instances of suspected or established blood clotting within the pump at six months, which is a major milestone for those of us working tirelessly to improve clinical outcomes for patients living with advanced heart failure,” said Mandeep R. Mehra, M.D., medical director of Brigham and Women’s Hospital Heart and Vascular Center in Boston.
The MOMENTUM 3 study includes more than 1,000 patients with New York Heart Association (NYHA) Class IIIB or IV heart failure. Patients were followed for a short-term endpoint of six months and continue to be followed for a long-term endpoint of two years.
Product page: HeartMate 3 LVAD…