St. Jude Medical has reported positive results from its MOMENTUM 3 clinical study comparing the HeartMate 3 Left Ventricular Assist System (LVAS) to the HeartMate II LVAS in treating advanced stage heart failure.
The HeartMate 3 LVAS is a small, implantable mechanical circulatory support (MCS) device designed for advanced heart failure patients either awaiting transplantation or not suited for heart transplantation.
The device is based on Full MagLev technology which minimises complications and reduce blood trauma through gentle blood handling and allows the suspension of the device’s rotor by magnetic forces to reduce trauma to blood passing through the pump.
The HeartMate 3 LVAS features a centrifugal blood pump that is implanted directly onto a patient's native heart to support the pumping ability of the weakened heart's left ventricle.
The patient wears an external, wearable controller and battery system to power the pump which can pump up to 10l of blood per minute.
The prospective, multi-centre, randomised, unblinded MOMENTUM 3 IDE study was conducted to test the safety and efficacy of HeartMate 3 LVAS while examining more than 1000 patients with advanced, refractory, left ventricular heart failure.
Results suggested the study meeting its primary endpoint, which was to achieve six months survival without disabling stroke and reoperation to repair or replace the device.
St. Jude Medical mechanical circulatory support vice-president and medical director Dr John B O’Connell said: “These data in the MOMENTUM 3 study represent the continued advancement in therapy options available for patients living with debilitating heart failure.
“The HeartMate II LVAS is an extremely important medical advancement with more than 24,000 implants having occurred to date, and it is the only LVAD approved for both Bridge-to-Transplant and Destination Therapy options in the US The data, now being seen with the HeartMate 3 LVAS, show that we are taking the next steps in advancing medical therapy options.”
Image: HeartMate 3 Left-ventricular Assist System. Photo: courtesy of Business Wire.