HDH Medical Ltd (HDH), is planning to complete the clinical trail entitled “Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis” for Hermetic Docking Head (HDH) device by June 2010. The trial is being conducted in Israel with an estimated patient enrollment of 10. The aim of the study is to evaluate the safety and efficacy of using HDH device and method an innovative anastomotic device for sutureless aortic anastomosis in patient diagnosed with abdominal aneurysm or Aorto-iliac aneurysm.
The open label, uncontrolled, single group assignment, safety/efficacy study is currently recruiting participants. The Principal Investigator of the study is Boris Yofee, MD from Barzilai Medical Center, Ashkelon, Israel.
HDH device is designed to create sutureless vascular anastomosis in various blood vessels. It connects the graft to the vascular wall. The product parts are attached to each other by the inversion device. The distal end (ends in the case of bifurcation) is cut as needed, according to the length of the damaged vessel. The polymer docking heads have conical or cylindrical shape according to the clinical application. On the external side of the cones are one or two rows of flexible metal barbs which ensure reliable non-migrating attachment of the product to the wall of the blood vessel. The flexibility of the barbs also prevents trauma to the vascular wall. The manner of attachment of the barbs to the polymer material permits only one way movement within the blood vessel. Diameters of the required docking heads are determined by the diameters of the graft and blood vessels.