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. The HeartMate 3 system utilizes Full MagLev technology, which 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."These data in the MOMENTUM 3 study represent the continued advancement in therapy options available for patients living with debilitating heart failure," said Dr. John B. O'Connell, vice president and medical director for mechanical circulatory support at St. Jude Medical. "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 U.S. The data, now being seen with the HeartMate 3 LVAS, show that we are taking the next steps in advancing medical therapy options." Study Oversight Committee includes:
- Dr. Mandeep R. Mehra (Chair, Publication and Presentation Committee), Brigham and Women's Hospital, Boston, MA
- Dr. Joseph Cleveland, University of Colorado, Denver, CO
- Dr. Daniel Goldstein, Montefiore Medical Center, NY, NY
- Dr. Nir Uriel, University of Chicago, Chicago, IL
According to the American Heart Association (AHA) and the Heart Failure Society of American (HFSA), about 6 million Americans are living with heart failure today, and 670,000 new cases are diagnosed each year. In the United States, the number of deaths from this condition has more than doubled since 1979.1About the HeartMate 3 Left Ventricular Assist System The HeartMate 3 LVAS includes a centrifugal blood pump that is implanted directly onto a patient's native heart and designed to supplement the pumping ability of the weakened heart's left ventricle, which is responsible for pumping oxygen-rich blood from the lungs throughout the body. The device is implanted above the diaphragm, immediately next to the native heart, and is attached to the aorta (the main artery that feeds blood into the entire body), leaving natural circulation in place while providing all of the energy necessary to propel blood throughout the body. The patient wears an external, wearable controller and battery system that powers the pump. The HeartMate 3 LVAS can pump up to 10 liters of blood per minute. About St. Jude Medical's Heart Failure Business St. Jude Medical is pioneering heart failure disease management with innovative solutions like the CardioMEMS ™ HF System, ground-breaking quadripolar technology and, in select European markets, the HeartMate 3 ™ left ventricular assist system and our first-to-market MultiPoint ™ Pacing technology. St. Jude Medical collaborates with heart failure specialists, clinicians and advocacy partners to provide a comprehensive product portfolio that includes innovative, cost-effective solutions that help reduce hospitalizations and improve patient quality of life for heart failure patients around the world. For more information about St. Jude Medical's focus on heart failure, visit the St. Jude Medical Heart Failure Media Kit or the St. Jude Medical PULSE Blog. Information for patients to learn more about heart failure can be found at www.heartfailureanswers.com. About St. Jude Medical St. Jude Medical is a leading global medical device manufacturer and is dedicated to transforming the treatment of some of the world's most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world.
Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 18,000 people worldwide and has five major areas of focus that include heart failure, atrial fibrillation, neuromodulation, traditional cardiac rhythm management and cardiovascular. For more information, please visit sjm.com or follow us on Twitter @SJM_Media.Forward-Looking Statements This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the company, including potential clinical successes, reimbursement strategies, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the company's control and the risk factors and other cautionary statements described in the company's filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the company's Annual Report on Form 10-K for the fiscal year ended January 2, 2016 and Quarterly Report on Form 10-Q for the fiscal quarter ended October 1, 2016. The company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.