The HeartMate 3 System offers advanced ventricular assist technology to support the management of patients with advanced stage heart failure
St Jude Medical, a global medical device company, has 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) utilising 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. 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,” said Kaustav Banerjee, senior regional director of South and Southeast Asia at St Jude Medical.
The HeartMate 3 system received CE Mark approval in October, 2015.
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