Each year, an international panel of experts, scientists and physicians gather to review the latest in medical technology. The HeartMate 3 LVAS was awarded in the category of Patient Care Improvement. The circulatory assist device is available to heart failure patients as a cardiac support option for advanced heart failure patients who are awaiting transplantation, are not candidates for heart transplantation, or are in myocardial recovery.
The St. Jude Medical Nanostim leadless pacemaker previously received the innovation award at CARDIOSTIM 2014.
“The CARDIOSTIM INNOVATION AWARDS aim at honoring the performance, achievement and cutting-edge technologies designed by manufacturers that are created to modernize medical practice and improve patient care,” said Dr. Philippe Ritter, chairman of CardioStim and heart rhythm specialist at the University Hospital of Bordeaux (France). “The HeartMate 3 cardiac assist device brings real benefit to patients suffering from heart failure and is an encouraging solution, in particular, for those awaiting transplantation.”
The HeartMate 3 LVAS is the first commercially approved centrifugal-flow left ventricular assist device (LVAD) utilizing 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.
“We are honored to receive this prestigious award from the clinical community for our HeartMate 3 System,” said Dr. Mark Carlson, vice president of global clinical affairs and chief medical officer at St. Jude Medical. “Heart failure remains one of the most costly epidemic diseases in the world, and the HeartMate 3 system is critical to helping physicians manage their complex patients battling such a challenging condition.”
CE Mark approval for the HeartMate 3 LVAS was based on data from the HeartMate 3 CE Mark clinical trial, which met its primary endpoint and demonstrated a 92 percent six month survival rate; the best six month survival rate to date to be documented in an LVAD CE Mark clinical study. Enrollment included both bridge-to-transplant and destination therapy patients in New York Hospital Association Class IIIb or IV heart failure. In the U.S., the HeartMate 3 LVAS is in an ongoing IDE trial.
The MOMENTUM 3 IDE trial, the largest of its kind, remains ongoing and will enroll more than 1,000 patients.
The HeartMate 3 LVAS is not approved for sale in the United States and limited by federal law to investigational use only.
Unlike artificial hearts, LVADs don’t replace the heart. Instead, the small implantable devices supplement the pumping function of the heart in patients whose hearts are too weak to pump blood adequately on their own. LVADs can benefit patients either awaiting transplant, known as bridge to transplant therapy, or can be used as a “destination therapy” for heart failure patients who need years of cardiac support but who are not candidates for transplantation.
The HeartMate 3 LVAS is implanted above the diaphragm, immediately next to the native heart, and is attached to the aorta 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. The design of the HeartMate 3 LVAD includes large, consistent blood flow gaps over a wide range of device operation levels, designed to reduce blood trauma. The artificial pulse technology is designed to further reduce adverse patient events including combating the formation of thrombus in the device.
St. Paul, Minn.-based St. Jude Medical Inc. is a global developer of medical technologies that treats conditions in four clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation.