ReliantHeart Receives CE Mark for HeartAssist5

Houston-based ReliantHeart has achieved CE Mark approval for design enhancements to its HeartAssist5 ventricular assist device, which includes True Flow remote monitoring. The implantable, electric pump is designed for use in patients with end-stage heart failure requiring ventricular support.

The enhancements involved supplements to the implanted inflow cannula portion of the device and sintering it with titanium beads, ReliantHeart Chief Financial Officer Sailesh Saxena told Device Daily Bulletin.

The CE Mark also includes remote monitoring via vadlink.com, which provides remote and true flow measurement of the device. ReliantHeart has customized the network for each implanting center so that real time data is available for monitoring by the implanting center clinicians.

According to Saxena, HeartAssist5 has already launched in Germany, the UK, Italy and Turkey, and will expand to other high-volume centers. The Houston-based company expects implants to occur as early as next week, he said.

The European market for VADs is in the 2,500-patient range, of which ReliantHeart expects to capture 5 percent, Saxena said. However, with rival Thoratec’s heart pumps showing higher clotting risk, the company believes “there is a great opportunity to take marketshare away from them,” Saxena added.

According to Saxena, ReliantHeart has supplemented the same enhancements for which it received its CE mark into an earlier approved randomized US trial, and on approval of the enhancements expects to start the trial late this summer. — Kellen Owings

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