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FDA drops access points from Sapien transcatheter valve label
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Direct Flow Medical is the latest company to start a transcatheter aortic valve replacement clinical trial in the United States, bringing a new name to the field, which has so far been dominated by major players like Edwards Lifesciences and Medtronic.
The California-based company’s SALUS trial is a 30-patient, single-arm, nonrandomized, multicenter feasibility study to assess the safety and efficacy of its Transcatheter Aortic Heart Valve System, which has already received the CE Mark and is commercially available in Europe.
Dr. William O'Neill
The device is delivered through the femoral artery, has a metal-free frame, and a "low-profile delivery system designed to eliminate aortic regurgitation," according to a company statement.
"A device that is repositionable and able to pass through smaller-diameter blood vessels is an important advance in the next generation of transcatheter aortic valve replacement [TAVR] systems," Dr. William O’Neill of Henry Ford Hospital, Detroit, who performed the first Direct Flow Medical case in the United States, said in the statement. "This could help patients who have not been good candidates for earlier TAVR devices," he added.
September was relatively eventful for TAVR. Earlier in the month, the Food and Drug Administration gave the green light to Edwards to start a clinical trial on Sapien 3. And just a day before Medicare added Direct Flow’s SALUS trial to the list of its approved studies, the FDA dropped reference to specific access points from the labeling of Edwards’ Sapien valve, which is the only FDA-approved valve in the United States.
Direct Flow is planning to seek FDA approval in 2017, according to an article in the Press Democrat, a newspaper in the company’s home town of Santa Rosa, Calif.
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