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Cardiovascular

Direct Flow Medical Announces Fifth Patent Issuance Of Their Unique Percutaneous Aortic Valve Technology

Direct Flow Medical, Inc. a privately held, emerging medical device Company developing a next generation, minimally invasive implant to treat patients with heart valve disease announced the issuance of its 5th patent on their Percutaneous Aortic Valve (PAV) Technology. The patent (USP# 7,534,259) entitled: "Nonstented Heart Valves with Formed in situ Support" provides further protection for this second generation PAV device. The Direct Flow Medical PAV System is a non-metallic, expandable cuff, bovine pericardial tissue valve that allows the physician to assess the hemodynamic outcomes prior to final deployment of the device. The unique and easily repositionable "stentless" valve conforms to the native annulus resulting in tight sealing of the valve which minimizes any paravalvular leaks. The reduction of aortic insufficiency is believed to improve clinical status in these high risk patients with significant co-morbidities including coronary heart disease and congestive heart failure. "We are delighted that we continue to receive significant protection for our second generation PAV technology," stated Bernard Lyons, President & CEO. "The unique design features of our device have now been awarded key claims regarding controlled deployment, positioning and retrieval. In addition to a major clinical advantage of the Direct Flow Medical PAV system that allows placement without hemodynamic compromise, our device is immediately competent upon the inflation of the initial ring in the left ventricle." Added Lyons: "We are most pleased with the progress we have made in the last 12 months with three new patents issued and another allowed which is a testament to the counsel and guidance of our patent attorneys at Knobbe, Martens, Olsen & Bear, LLP, led by Gerard von Hoffman." The Company"s comprehensive intellectual property strategy has been built on the seminal patent issued to inventor and world renowned pioneer in interventional cardiology and treatment of valvular disease, Dr. Peter Block, Emory University. This patent (USP# 5,554,185) entitled: "Inflatable Prosthetic Cardiovascular Valve for Percutaneous Translumenal Implantation of Same" was issued in 1996 and was assigned exclusively to Direct Flow Medical upon its founding in 2004. The "185 Block patent represents one of the earliest innovations in the fast emerging space of transcatheter aortic valve implantation (TAVI). "I am excited that the Company"s Founders, Randy Lashinski and Gordon Bishop, have continued to advance my original invention and moreover, that the Company has rapidly progressed in its clinical assessment of this unique second generation technology in humans," stated Dr. Block. "The Company"s recent announcement of the first human use of the first ever repositionable and retrievable 18F system is a major advancement to the field." Direct Flow Medical, Inc.


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