SANTA ROSA, Calif.--(BUSINESS WIRE)--Direct Flow Medical®, Inc., a transcatheter heart valve innovator focused on improving patient outcomes, today announced it has been awarded U.S. Patent No. 8,377,118 by the U.S. Patent and Trademark Office (USPTO) and Japanese Patent No. 5,119,148 by the Japan Patent Office. The company’s proprietary technology encompasses a distinctive transcatheter aortic heart valve with a metal-free frame and flexible, low-profile delivery system that virtually eliminates aortic regurgitation.
“Our unique solution to the major clinical issues associated with transcatheter aortic valve replacement (TAVR) has enabled us to build an impressive intellectual property portfolio”
Post-procedural aortic regurgitation has been shown to be a predictor of long-term mortality1. The Direct Flow Medical Transcatheter Aortic Valve System is designed to address this clinical concern by allowing complete assessment of hemodynamic performance, repositioning and retrieval after the valve is fully deployed in the native valve annulus. The system is designed to improve the long term survivability of patients by resolving the clinical issues associated with current commercial valves.
The Company now has 13 issued U.S. patents and 24 additional patent applications filed in the U.S. or under the Patent Cooperation Treaty.
“Our unique solution to the major clinical issues associated with transcatheter aortic valve replacement (TAVR) has enabled us to build an impressive intellectual property portfolio,” said Gordon Bishop, Direct Flow Medical’s Chief Technology Officer, co-founder and inventor of the two recently awarded patents. “With issued U.S. and foreign patents, our intellectual property portfolio has global breadth, and we intend to continue to expand it as we develop and refine additional technologies.”
The company recently received a CE Mark for the Direct Flow Medical system and is currently commercializing two sizes of valves, 25mm and 27mm.
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 exploring application of its proprietary technology beyond the aortic valve, to the mitral valve and other valve anatomy. Headquartered in Santa Rosa, California, the company also has technology and manufacturing facilities in Lake Forest, California. 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 more information, please visit: www.directflowmedical.com.
1Toggweiler S, Humphries KH, Lee M, et al. 5-year outcome after transcatheter aortic valve implementation. JACC 2013;61(4):413-9.
The Direct Flow Medical® Transcatheter Aortic Valve System has not been approved for use in the U.S., Canada or Japan.