May 31 2016, 12.47 PM IST || Pocket News Alert
The HeartMate 3 System offers physicians in India the most advanced ventricular assist technology available to support the management of patients with advanced stage heart failure
Pune, India. – May 31, 2016 – St. Jude Medical, Inc. (NYSE: STJ), a global medical device company, today announced approval and launch of the HeartMate 3™ Left Ventricular Assist System (LVAS) in India. The HeartMate 3 LVAS is 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 HeartMate 3 system allows me to offer my advanced heart failure patients an option for their complex heart condition and we look forward to making this system broadly available throughout India,” said Dr. Kewal Krishan, Program in-charge – heart transplant and ventricular assist devices senior consultant, Max Super Specialty Hospital, Saket, India.
The HeartMate 3 system is the first commercially approved centrifugal-flow left ventricular assist device (LVAD) utilizing Full MagLev™ (fully magnetically-levitated) 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.
The device 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.
Approval for the HeartMate 3 system 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. St. Jude Medical expects a limited market release across India to begin immediately, with additional market releases taking place throughout 2016.
“We are pleased to launch the next-generation HeartMate 3 system in India. The device has been proven through the CE Mark clinical study to show high patient survival rates, improvements in functional status, and very low adverse event rates highlighted by zero pump thrombosis events,” said Kaustav Banerjee, senior regional director of South and Southeast Asia 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 supporting physicians managing the care of patients battling such a complex and challenging condition.”
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 system received CE Mark approval in October, 2015.
About 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, our first-to-market MultiPoint™ pacing technology and, in select European markets, the HeartMate 3™ left ventricular assist system. St. Jude Medical collaborates with heart failure specialists, clinicians and advocacy partners to provide 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 heartfailureanswers.com.
About St. Jude Medical
St. Jude Medical is a global medical device manufacturer 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 has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com or follow us on Twitter @SJM_Media.