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November 14th – November 20th

November 15th: FDA Clears GORE PROPATEN Vascular Graft

W. L. Gore & Associates (GORE) today announced that the U.S. Food & Drug Administration (FDA) has given the company clearance to market its GORE PROPATEN Vascular Graft for peripheral use, including lower-limb bypass and dialysis access surgery. The GORE PROPATEN Vascular Graft is the first ePTFE vascular graft that reduces thrombosis(1)--or clotting--and is designed to address the clinical problem of thrombotic vascular graft failure. The GORE PROPATEN Vascular Graft is the first and only ePTFE-heparin combination in an emerging class of medical products that combine mechanical and biological elements. It is designed to address the gap in clinical performance between synthetic and vein grafts by bonding the anticoagulant drug heparin to the surface of the graft using proprietary heparin end-point covalent bonding.

As many as 12 million Americans over the age of 50 are affected annually by Peripheral Arterial Disease (PAD). PAD manifests as a built-up of plaque in the wall of an artery resulting in either narrowing or blocking of the artery, limiting blood flow to the limbs. Surgical vascular bypass is a common treatment for PAD. The use of autologous veins as a bypass conduit has been the standard of care for below-knee bypasses as synthetic grafts historically have not matched their clinical performance.

Over 10,000 GORE PROPATEN Vascular Grafts have been successfully implanted worldwide in four years of commercial availability overseas. The average one-year primary patency for the GORE PROPATEN Vascular Graft in below-knee bypasses has been reported to be 80 percent.(2) This compares favorably to the average one-year patencies for autologous vein grafts (81 percent) and ePTFE synthetic grafts (66 percent) in the same application.(3)

The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 18 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide.

November 20th: Cardica Receives 510(k) Clearance for C-Port xA(TM) Distal Anastomosis System for Use in Coronary Artery Bypass Surgery

Cardica, Inc. (Nasdaq: CRDC ) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its C-Port xA(TM) Distal Anastomosis System in the U.S. The C-Port xA system is the next generation of Cardica's C-Port system, and automates the creation of anastomoses, or attachments of blood vessels and grafts, such as those in coronary artery bypass graft (CABG) surgeries.

"With the C-Port xA system, surgeons can perform completely automated, predictable, and compliant anastomoses in a broad range of CABG procedures. No additional stitches at the anastomosis site are required," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica, Inc. "We believe that this clearance will help drive adoption of our automated anastomosis system, particularly in beating heart surgeries where the C-Port xA system's ease-of-use, reliability and enhanced features are especially useful."

The C-Port xA Distal Anastomosis System Advantage

The C-Port xA system features several innovative modifications to Cardica's C-Port product offering. The C-Port xA system is designed to deploy staples around the periphery of the anastomosis to help provide leak-proof sealing. Other features include improved access to the coronary artery and reduction of target site preparation; optimization of the staple configuration; and incorporation of vessel clamps for ease of loading the graft vessel for anastomosis. Unlike most hand-sewn anastomoses, the C-Port Xa system enables a compliant anastomosis that can expand and contract with blood-flow.

The C-Port xA system received the CE Mark in July 2006 and is currently marketed in Europe.

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