December 8, 2016 — St. Jude Medical Inc. announced results of the MOMENTUM 3 U.S. IDE Clinical Study during a late-breaking clinical trial session at the American Heart Association (AHA) Scientific Sessions, Nov. 12-16 in New Orleans. The MOMENTUM 3 study compared the HeartMate 3 Left Ventricular Assist System (LVAS) to the HeartMate II LVAS in treating advanced stage heart failure, and is the largest LVAD trial in the world to evaluate both short-term and long-term patients in a single study. The study results demonstrated patients receiving the HeartMate 3 LVAS had an 86.2 percent survival rate with freedom from disabling stroke and reoperation to repair or replace the device.
The MOMENTUM 3 IDE study is a prospective, multi-center, randomized, unblinded study evaluating the safety and effectiveness of the HeartMate 3 LVAS when used for the treatment of advanced, refractory, left ventricular heart failure. More than 1,000 patients with New York Heart Association (NYHA) Class IIIB or IV heart failure are participating in the study. Patients are being followed for a short-term endpoint of six months, and a long-term endpoint of two years. Current data show the results at the six-month follow-up in the first 294 patients enrolled.
The primary endpoint for the study was six months survival with freedom from disabling stroke and reoperation to repair or replace the device. The study met its primary endpoint (non-inferiority P<0.0001; superiority P=0.037). There were no pump thrombosis events reported in patients who were implanted with HeartMate 3 LVAS at six months, confirming the results observed with the HeartMate 3 LVAS in the CE Mark trial.
Rates of all other adverse events were similar between the HeartMate 3 LVAS and historical rates seen in the HeartMate II LVAS. This study included all-comers, which means researchers evaluated the device regardless of whether the patient needed a short-term support option while awaiting transplantation or a long-term support option for those who are not candidates for cardiac transplantation.
“The Heartmate 3 LVAS improved clinical outcomes in the MOMENTUM 3 study by avoiding the need for surgical reoperation to replace or remove the pump due to pump thrombosis,” said Mandeep R. Mehra, M.D., medical director of Brigham and Women’s Hospital Heart and Vascular Center in Boston. “More importantly, these clinical gains occurred without an increase in other adverse events, providing important therapeutic progress for our advanced heart failure patients.”
The HeartMate 3 LVAS is a small, implantable mechanical circulatory support (MCS) device for advanced heart failure patients who are awaiting transplantation or are not candidates for heart transplantation. It is the first commercially approved (CE marked) LVAD with Full MagLev technology, designed to minimize complications and restore blood flow. Full MagLev technology allows the device’s rotor to be “suspended” by magnetic forces. This design aims to reduce trauma to blood passing through the pump and improve outcomes for patients.
The HeartMate 3 LVAS is CE Mark approved and limited by federal law to investigational use in the United States.
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