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Confluent Surgical, Inc. Announces DuraSeal Xact(TM) System Receives CE Mark For Spine Applications


10/19/2005 5:12:41 PM

WALTHAM, Mass., Sept. 23 /PRNewswire/ -- Confluent Surgical, Inc. announced today at the 2005 EuroSpine Conference in Barcelona, Spain that a CE Mark has been granted for the DuraSeal Xact Sealant System for use as a surgical sealant. DuraSeal Xact System is indicated for use as an adjunct to standard methods of dural repair, such as sutures, to provide watertight closure during lumbar spine procedures. There are approximately 250,000 lumbar spine procedures each year in Europe and it is estimated that there is a 5-10% rate of incidental occurrence of dural tears that lead to cerebrospinal fluid leaks. Over 1,500 neurosurgeon and orthopaedic spine surgeons worldwide attend the EuroSpine Conference.

The DuraSeal Xact Sealant System utilizes the unique DuraSeal technology that is a patented, synthetic, absorbable hydrogel delivered by the MicroMyst(TM) applicator. The MicroMyst applicator is a custom-designed, air- assisted sprayer that allows the spine surgeon precise control of the location and quantity of the sealant application. The DuraSeal Xact Sealant System can be stored at room temperature and prepared in less than two minutes. When sprayed on the dura, a strong, adherent sealing layer is produced and effectively seals the suture line within seconds. A feature unique to the DuraSeal Sealant is the blue colorant that provides the spine surgeon excellent visualization of coverage and thickness of the material upon application to the spinal dura. 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.

"DuralSeal is great for cases where the dural closure is tenuous for whatever reason. The new MicroMyst applicator ensures that the sealant only goes where you want it to go and the blue color gives confidence that it is in the right place," stated by Michael Groff, M.D., Co-Director of the Spinal Cord Injury Center at Indiana University Medical Group.

"DuraSeal may help to reduce the incidence of post-operative CSF leaks, thereby reducing the risks of post-operative infections and allowing earlier patient mobility. This may result in improved patient outcomes, and reduced in-hospital costs," said William Welch, M.D., Chief of Neurological Surgery at the University of Pittsburgh Medical Center.

"We are very pleased to be able to extend the DuraSeal brand into spine surgery, where the need for an effective sealant is critical. This is an important market for Confluent, and our sales and distribution channel is well suited to take advantage of this approval," said Amar Sawhney, Ph.D., Co- Founder, President & CEO of Confluent Surgical.

Confluent Surgical has established an extensive and distinguished neurosurgeon focused distribution channel to represent the DuraSeal Xact Sealant System throughout Europe. 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.

For additional information, visit the Confluent Surgical and DuraSeal websites at http://www.confluentsurgical.com and http://www.duralsealant.com or contact Bobbie Sawyer at rsawyer@confluentsurgical.com

Confluent Surgical, Inc.

CONTACT: Bobbie Sawyer of Confluent Surgical, Inc., +1-781-693-2328,bsawyer@confluentsurgical.com



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