A Medical Device Daily
Direct Flow Medical (DFM; Santa Rosa, California), a privately held, emerging device company developing a next-generation, minimally invasive implant to treat patients with heart valve disease reported the issuance of its 5th patent on its Percutaneous Aortic Valve (PAV) technology. U.S. patent No. 7,534,259, titled "Nonstented Heart Valves with Formed in situ Support," provides further protection for this second generation PAV device.
The Direct Flow 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 repositionable "stentless" valve conforms to the native annulus resulting in tight sealing of the valve which minimizes any paravalvular leaks, the company said. 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.
"The unique design features of our device have now been awarded key claims regarding controlled deployment, positioning and retrieval," said Bernard Lyons, president/CEO of DFM. 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." Lyon said that in the last 12 months the company has been issues three new patents and allowed another.
In other patent news, CPC of America (Las Vegas) reported the filing of its first patent on a synthetic sealant for specific application to the MedClose VCS.
CPC is focused on the development and testing of the MedClose VCS, which is an internal puncture-closing system for use in percutaneous intravascular diagnostic and interventional procedures. In addition, CPC is focused on the development of its own synthetic sealant product line for various clinical applications not limited to vascular closures devices.
The MedClose VCS device consists of two parts; 1) a delivery system that delivers the sealant to the puncture site, and 2) the synthetic sealant itself.
The company said it believes that its sealant offers some "important advantages" over the plasma-based sealant it had originally intended to utilize in several respects.
As a synthetic sealant, the company said its product is free from the risk of blood-borne and other pathogens. Also, testing to date indicates that the sealant is highly adhesive and may ultimately prove to be more adhesive than any other plasma-based sealant presently available. In addition, these tests show that the sealant has excellent adhesive strengths when applied to wet areas and may have greater adhesive strength on wet areas than any other sealant on the market, which could be a tremendous competitive advantage due to the fact that vascular closure sites are normally initially wet due to arterial bleeding from the arteriotomy.
Finally, the synthetic sealant appears to perform independently with respect to the level of anti-coagulation present.
CPC develops therapeutic devices for use in endovascular procedures.