FDA clears pivotal trial for permanent use of artificial heart

Normal heart and the SynCardia Total Artificial Heart--Courtesy of SynCardia Systems

SynCardia Systems is aiming to have the first artificial heart approved by FDA for permanent use. The agency has approved a pivotal trial design to test the startup's Total Artificial Heart as a heart replacement.

FDA has already approved the device as a temporary bridge to transplant for people suffering from end-stage biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive. It also has a CE mark and Health Canada approval.

The longest patient to live on with an implanted Total Artificial Heart used the device to wait almost four years until he received a heart plant. The new study will be in 19 patients who need a heart transplant but are not eligible for one under the rules guiding organ transplantation. Clinically stable patients with the device will also receive the FDA-approved Freedom portable driver, which allows patients more mobility.

"This is an important step for SynCardia to advance the use of the Total Artificial Heart to a new group of patients who are not currently eligible for a donor heart," Michael Garippa, president and CEO of SynCardia, said in a statement.

He added, "The study will generate data on the effective use of the SynCardia Heart in these patients as a way for them to recover from heart failure and continue with a near-normal lifestyle."

Like a donor heart transplant, the Total Artificial Heart replaces the patient heart's two failed ventricles and four valves. The device is made of segmented polyurethane solution, for which the startup said it is the sole source worldwide.

Frederic Thiollet has had his SynCardia Total Artificial Heart for nearly three and a half years.--Courtesy of SynCardia Systems

More than 1,350 Total Artificial Hearts have been implanted in patients already for a total of more than 400 patient years of device use. According to SynCardia, 79% of its bridge patients have gone on to receive a donor heart--which it claims is the highest success rate for any such device.

In a 10-year pivotal study that supported the temporary-use FDA approval, 75% of patients receiving the Total Artificial Heart were out of bed within one week after implant. After two weeks, 60% could walk more than 100 feet. Patient liver and kidney function had "improved significantly" and was "trending to normal" at two weeks after surgery, according to the company's website.

In October, the startup said in an SEC filing that it had raised $6.4 million of a targeted $15 million financing. Founded in 2001, its investors include SamiHaan Capital Partners, Seneca Partners and Iron Gate Capital.

- here is the release

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