CE Mark for New Size of Direct Flow Transcatheter Valve Plus No Use of Contrast Media

No doubt familiar to followers of transcatheter valve evolution, Direct Flow Medical®, Inc., has received the CE Mark for a 23mm sized valve as part of its Direct Flow Medical Transcatheter Aortic Valve System, expanding the patient population that can be treated with its technology. The company also announced receipt of the CE Mark for implantation of all of its valves without the use of contrast media, protecting patients from kidney injury during transcatheter aortic valve implantation (TAVI).

Background

Readers of our pages will be familiar with Direct Flow’s TAVI offering, it being perhaps the most identifiably different approach to minimally invasive insertion and placement of an aortic valve. Direct Flow valves feature a unique, double-ring design that conforms to the anatomy and creates a tight and durable seal around the annulus. The valves allow for complete assessment of hemodynamic performance and unlimited repositioning until optimal results are obtained. All valves can be delivered through the same, low profile, and flexible delivery system. The Direct Flow Medical valve is designed to improve TAVI outcomes by virtually eliminating aortic regurgitation, offering unlimited repositionability during the procedure and reducing overall complications.

With this new approval the company now has a valve portfolio that includes 23mm, 25mm, 27mm and 29mm valves, which can treat patients with annulus sizes from 19mm to 28mm.

Turning to the second approval, this is equally significant for company and patient alike, because acute kidney injury, often as a result of the use of toxic contrast media, occurs in about 22 percent of patients undergoing TAVI, increasing their risk of peri-procedural complications, prolonged hospitalization and mortality.

Company comments

“These approvals are a testament to our continuous focus on innovation and patient outcomes. Physicians will not only be able to treat a broader patient population, but will also be able to implant this technology with no contrast and no compromises,” said Bernard Lyons, Chief Executive Officer of Direct Flow Medical. “Our pipeline of structural heart technologies is strong and we continue to invest in new products and new indications for our unique therapeutic platform.”

“Use of contrast during angiographic procedures is a well-documented cause of acute kidney injury,” said Direct Flow Medical Chief Medical Officer Charles Davidson, M.D. “By eliminating or reducing the quantity of contrast administered during TAVI, we will be able to better protect the kidneys and minimize peri-procedural complications.”

Source: Direct Flow Medical, Inc.

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