In addition, the company has received CE Mark approval for implantation of all of its valves without the use of contrast media, which allows in protecting patients from kidney injury during transcatheter aortic valve implantation (TAVI).
With this approval, currently, the company has valve portfolio, including 23mm, 25mm, 27mm and 29mm to treat patients with annulus sizes from 19mm to 28mm.
The valves feature double-ring design, which conforms to the anatomy and creates a tight and durable seal around the annulus.
Direct Flow Medical chief medical officer Bernard Lyons said the approvals are a testament to firm’s focus on innovation and patient outcomes.
"Our pipeline of structural heart technologies is strong and we continue to invest in new products and new indications for our unique therapeutic platform," Lyons added.
The company has designed the valve to improve TAVI outcomes by eliminating aortic regurgitation, offering unlimited repositionability during the procedure and reducing overall complications.
Direct Flow Medical chief medical officer Charles Davidson said, "Use of contrast during angiographic procedures is a well-documented cause of acute kidney injury."
The Transcatheter Aortic Valve System is commercially available in Europe, while the company is trying for regulatory approval in the US.
