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Confluent Surgical, Inc. Release: DuraSeal(R) Sealant Receives CE Mark For Vascular Applications


2/2/2006 10:43:01 AM

WALTHAM, Mass., Feb. 1 /PRNewswire/ -- Confluent Surgical, Inc. announced today that a CE Mark has been granted for the DuraSeal Sealant System for use as a surgical sealant during arterial and venous reconstructions to seal suture lines as an adjunct to standard closure techniques in vascular surgery. By providing a seal in vascular surgery, DuraSeal Sealant offers surgeons' a valuable tool to reduce bleeding from the suture line in bypass procedures, as an example, and to prevent post-operative complications associated with suture line bleeding. The DuraSeal technology is a patented synthetic, absorbable hydrogel delivered by a dual syringe applicator. The device can be stored at room temperature and prepared in less than two minutes. DuraSeal Sealant polymerizes within seconds when sprayed on the suture line. A feature unique to the DuraSeal Sealant is the blue colorant that provides the vascular surgeon excellent visualization of coverage and thickness of the material upon application. Postoperatively, the DuraSeal Sealant continues to seal the suture line as healing progresses under the gel. After several weeks, the hydrogel breaks down into water-soluble molecules that are absorbed and cleared through the kidneys.

"Consistent, immediate sealing of the suture line to prevent bleeding has to date been an elusive goal in various vascular bypass procedures. This sealant is easy to apply, adheres well to tissues and graft materials and is a very valuable adjunct to achieving hemostasis especially in patients who are on antiplatelet agents in addition to their anticoagulation. I'm confident it will play a major role in the surgeon's armamentarium to achieve hemostasis in vascular reconstructions," said Sean D. O'Donnell, M.D., Director, Section of Vascular Surgery at Washington Hospital Center in Washington, D.C.

"DuraSeal is enjoying tremendous success in cranial and spinal dural sealing indications. This approval, in addition to our lung sealing CE Mark approval, greatly expands the market potential for DuraSeal Sealant. We have seen a tremendous reception for our DuraSeal internationally and we are looking forward to making it a commercial success in the United States," said Amar Sawhney, President & CEO of Confluent Surgical.

There are approximately 880,000 peripheral vascular procedures performed worldwide each year and approximately 400,000 of those procedures are performed in the United States. The majority of those cases involve suturing of a graft for which a sealant is applicable to immediately stop the bleeding. Confluent Surgical plans to initiate a vascular sealing study in the United States this year.

Confluent Surgical is a private medical device company that is pioneering the development of in-situ-polymerized biomaterials. The synthetic materials are safe, simple to use, and allow the formation of customized implants at the site of disease. These materials have potentially numerous applications across several surgical disciplines. DuraSeal Sealant is currently the only sealant approved in the United States for cranial dural sealing.

For additional information, visit the Confluent Surgical and DuraSeal website at http://www.confluentsurgical.com or contact Patrick O'Donnell, Director of Global Marketing, at podonnell@confluentsurgical.com

Confluent Surgical, Inc.

CONTACT: Patrick O'Donnell, Director of Global Marketing of ConfluentSurgical, Inc., +1-781-693-2328, podonnell@confluentsurgical.com



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