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Medical Devices / Submissions and Approvals

Key Component to Artificial Heart Wins FDA Approval

Aug. 6, 2014
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Artificial heart maker SynCardia Systems plans to launch its SynCardia Total Artificial Heart with SynHall valves throughout the U.S. within a couple of weeks, following receipt of FDA approval on July 2, the company said Tuesday.

Approval of the SynHall valves gives the company control over the last component needed to manufacture the artificial heart, which serves as a stop-gap measure for patients with end-stage biventricular heart failure who are awaiting a heart transplant.

The titanium and pyrolytic carbon SynHall valves use the same design, materials and a similar manufacturing process as the tilting-disk valves that are normally used in the total artificial heart, according to the company. More than 5,000 valves have been implanted over the past 30 years, SynCardia adds.

The devicemaker also controls the rights to segmented polyurethane solution, which is used for blood contacting and flexing components — e.g., housings, diaphragms and connectors — of the artificial heart such as the housings, diaphragms and connectors.

SynCardia received a CE Mark for use of SynHall valves with the artificial heart. Health Canada approved the valves for the same indication last week, the company said. — Kellen Owings

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