ReliantHeart said yesterday it won CE Mark approval in the European Union for its aVAD left ventricular assist device.
The aVAD device is an axial flow LVAD that features remote monitoring and flow measurement, according to an MD+DI report.
ReliantHeart said that manufacturing of the device is already underway, with 65 units slated to be shipped out in September and October and 100 units expected to be available by year end, according to the report.
A planned launch of the device is scheduled at specific centers in Germany, Turkey and London, with pricing similar to Thoratec’s HeartMate 3 LVAD.
The aVAD device shares a pump blood path with the company’s previously CE Mark approved HeartAssist 5 LVAD, which allowed the aVAD device to gain CE Mark approval without a trial, according to the report.
The company said it is anticipating a human FDA IDE trial in early 2017.
Competitors in the LVAD market are growing as they get picked up by major players in Medtech. Thoratec was bought by St. Jude Medical (NYSE:STJ) last year, which was picked up by Abbott (NYSE:ABT) earlier this year and HeartWare International (NSDQ:HTWR) is being snagged by Medtronic (NYSE:MDT) in a deal announced in June.