Singapore, August 23, 2007: St Jude Medical has received regulatory approval from the Ministry of Health, Labor and Welfare (MHLW), in addition to reimbursement approval, for the Angio-Seal STS Plus Vascular Closure device.

 

Angio-Seal STS Plus is designed to provide physicians with an improved method of sealing catheterization sites, allowing patients increased comfort and offering hospitals improved efficiencies. Approved for both percutaneous peripheral and cardiac interventional catheterization procedures, the device enables physicians to quickly seal femoral artery punctures made during those procedures.

 

The device offers a significant advantage over the Angio-Seal Millennium vascular closure platform, which has been used in Japanese catheterization labs since 2004. With the addition of a self-tightening suture, the Angio-Seal STS Plus allows vascular closure to be completed entirely in the catheterization lab, saving labor and reducing the length of time required to complete the procedure.

 

Nearly 10 million catheterizations are performed worldwide each year. In these procedures, a catheter, or thin tube, is inserted into the femoral artery in the leg. Physicians then deliver diagnostic tools or interventional therapies, such as balloons, stents and medications, through the catheter to the point of treatment.

 

The Angio-Seal STS Plus device offers quick, consistent and predictable hemostasis (cessation of bleeding) at the puncture site. Its fast, secure closure reduces the risk of complications and can allow patients to resume activities sooner than if managed with manual compression.

 

“Japanese approval for the Angio-Seal STS Plus device will further reinforce the strong worldwide market position that the Angio-Seal system holds,” said Paul Bond, President, St Jude Medical Japan. “Since 1996, more than nine million Angio-Seal devices have been distributed and more than 250 studies have documented their benefits to doctors, patients and hospitals. These findings, and the experience of thousands of physicians around the world, are helping to establish the Angio-Seal device as the standard of care in vascular closure.”

 

The Angio-Seal STS Plus device includes a small bio-resorbable anchor, suture and collagen pad. The anchor is placed in the artery through a small delivery system and secured against the artery's interior wall. Then the collagen pad, which is positioned on the outside of the artery, is bound together with the suture to form a secure seal. The self-tightening suture enables the physician to finalize the closure procedure immediately. Unlike many other vascular closure devices, all components of the Angio-Seal STS Plus device are fully absorbed with 60 to 90 days, so no foreign material permanently remains in the body.

 

If physicians need to repeat catheterization at a later time, they can re-access the original site, within one centimeter, when the Angio-Seal STS Plus device has been used to close the original site.