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Direct Flow Medical

Santa Rosa, California, United Statesdirectflowmedical.com ↗

Ownership: Private
Employees: ~250
Development stage: Commercial

Overview

Direct Flow Medical developed a novel transcatheter aortic heart valve system designed to minimize the risk of aortic regurgitation and improve outcomes for patients with severe aortic stenosis. The system was CE-marked and commercially available in Europe but did not achieve FDA approval before the company ceased operations. Clinical studies demonstrated technical feasibility, safety, significant reduction in transaortic gradient, and minimized paravalvular leak.

Therapeutic areas: Cardiovascular
Modalities: DeviceBiologic (bovine pericardial tissue valve)
Industry: Implantable Medical Devices

Partnerships

None reported as major pharma/biotech partnerships prior to closure.

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