News | Ventricular Assist Devices (VAD) | December 08, 2016

HeartMate 3 LVAS Demonstrates Improved Clinical Outcomes for Advanced Heart Failure Patients

Patients experienced 86.2 percent survival rate with freedom from disabling stroke and reoperation to repair or replace the device

St. Jude Medical, HeartMate 3 LVAS, MOMENTUM 3 IDE study results, AHA Scientific Sessions 2016

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.

For more information: www.sjm.com

Related Content

Edwards Lifesciences Centera self expanding transcatheter (TAVR) valve
News | Heart Valve Technology| May 24, 2017
May 24, 2017 — Late-breaking data presented at EuroPCR 2017 demonstrating excellent clinical outcomes for...
3-D Echo Image Analysis With Philips' HeartModel A.I. is Accurate and Reproducible
News | Cardiovascular Ultrasound| May 24, 2017
May 24, 2017 — Philips recently announced the results from a global study indicating that automated...
Heart Failure Mortality Inversely Related to Wealth of Country
News | Heart Failure| May 24, 2017
Death in patients with heart failure is inversely related to the wealth of the country they live in, according to late...
Shockwave Medical Announces CE Mark for Coronary Lithoplasty System and Activities at EuroPCR 2017
News | Cath Lab| May 23, 2017
Shockwave Medical announced last week CE Mark for the company’s Coronary Lithoplasty System for the treatment of...
New Paper Highlights Success of Advanced Treatments in Complex Aortic Aneurysm Repair
News | Endovascular Aortic Repair| May 23, 2017
Significant success has been achieved in treating complex proximal aneurysms using a combination of fenestrated and...
Risk of Heart Transplant Rejection Reduced by Desensitizing Patient Antibodies
News | Cardiovascular Surgery| May 23, 2017
The risk of heart transplant rejection can be reduced by desensitizing patient antibodies, according to research...
News | Heart Failure| May 22, 2017
Serelaxin failed to meet the primary endpoints of the phase 3 RELAX-AHF-2 trial, according to late-breaking results...
Consumers Warned About Accuracy of Heart Rate Apps in New Study
News | Mobile Devices| May 22, 2017
May 22, 2017 — Consumers are being warned about the accuracy of heart rate apps after a study found huge variability
Overlay Init