Medical technology company Medtronic plc (NYSE:MDT) reported on Tuesday the receipt of the CE (Conformite Europeenne) Mark for HVAD
System left ventricular assist device (LVAD) technique for a less-invasive implant procedure in patients with advanced heart failure.
HeartWare has written to cardiologists who have implanted the HeartWare HVAD
system and to HeartWare clinicians, advising them of this issue and the recall procedure.
HeartWare has delivered advancements for patients suffering from heart failure, through the commercialization of the HVAD
system and pipeline development, and I am convinced that being part of Medtronic will allow us to accelerate meaningful innovations more quickly.
We decided to use a HVAD
, a golf ball-sized pump that would do the jobof a heart," Dr K R Balakrishnan, director, cardiac sciences, Fortis Malar, (http://timesofindia.
System enhances the portfolio of our Cardiac & Vascular Group, a team with a proven track record of executing and a demonstrated ability to scale early stage concepts into large, sustainable end markets," said Omar Ishrak, chairman and chief executive officer of Medtronic.
System is HeartWare's flagship product and features the world's smallest full-support circulatory assist device, the HVAD
Pump, which is designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant other devices.
The company added that LATERAL is a US Investigational Device Exemption (IDE) prospective clinical trial designed to study the clinical outcomes of patients with end-stage heart failure who are awaiting a heart transplant and are implanted with the HVAD
Pump through a less-invasive thoracotomy procedure.
The company says the HVAD
pump, with sintered inflow cannula, weighs approximately 5 ounces and displaces a volume of approximately 50 milliliters.
While our HVAD
and MVAD Systems offer minimally invasive treatments to end-stage heart failure patients, the SYNERGY platform offers even less invasive and ultimately interventional options to earlier-stage heart failure patients.
Sintering of the HVAD
pump on the outer surface of the implanted inflow tube is designed to promote tissue in-growth on the lower section of the inflow tube.
Under the ADVANCE study, 140 patients at 30 US clinical sites received HeartWare HVAD
pumps, making it the largest bridge-to-transplant pivotal trial to date.