Direct Flow Medical®, Inc., a transcatheter heart valve innovator focused on improving patient outcomes, today announced it has received the CE Mark (Conformité Européenne) 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).

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. All Direct Flow Medical 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.

“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.”

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.

Acute kidney injury occurs in about 22 percent of patients undergoing TAVI, increasing their risk of peri-procedural complications, prolonged hospitalization and mortality¹.

“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.”

The Direct Flow Medical Transcatheter Aortic Valve System is commercially available in Europe. In the U.S., the company is progressing towards regulatory approval and is currently enrolling patients in its SALUS pivotal trial.

About The Direct Flow Medical System

The benefits of the Direct Flow Medical Transcatheter Aortic Valve System are enabled by its design, which features a distinctive, metal-free frame. Rather than a metal stent, the Direct Flow Medical System incorporates a polymer frame, which is expanded using pressurized saline and contrast for placement, assessment and repositioning. The saline/contrast solution is easily exchanged for a quick-curing polymer that solidifies and secures the valve in place once optimal positioning is reached. The unique double-ring design of the valve creates a tight seal around the annulus. The system is fully repositionable and retrievable up until polymer exchange. The system avoids rapid pacing of the heart during deployment, and does not require post-dilatation following placement. The Direct Flow Medical Transcatheter Aortic Valve System is indicated for the treatment of patients with severe aortic stenosis who are at extreme risk for surgical aortic valve replacement (SAVR).The metal-free design enables a low-profile (18 French), fully sheathed delivery system for all valve sizes that minimizes vascular complications and improves hemodynamic outcomes.

About Direct Flow Medical, Inc.

Founded in 2004, Direct Flow Medical, Inc. is focused on developing novel transcatheter heart valve technologies that improve patient outcomes while reducing patient complications. The company is headquartered in Santa Rosa, California, with technology and manufacturing facilities in Lake Forest, California. The Company’s proprietary technology is not limited to aortic valve disease, and is readily applicable to mitral and other heart valve anatomical sites. Direct Flow Medical investors include EDF Ventures, New Leaf Venture Partners, Spray Venture Partners, Foundation Medical Partners, VantagePoint Venture Partners, ePlanet Venture Partners and strategic corporate investors.
For further information, please visit the Web site at http://www.directflowmedical.com.

The Direct Flow Medical Transcatheter Aortic Valve System has not been approved for sale in the USA, Canada or Japan.

Direct Flow Medical and the Direct Flow logo are trademarks of Direct Flow Medical, Inc.

¹Takagi H, Niwa M, Mizuno Y, Goto SN, Umemoto T. All-Literature Investigation of Cardiovascular Evidence Group. Incidence, predictors, and prognosis of acute kidney injury after transcatheter aortic valve implantation: a summary of contemporary studies using Valve Academic Research Consortium definitions. Int J Cardiol 2013;168:1631–5.

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