DuraSeal(R) Sealant CE Mark For Thoracic Applications
Waltham, MA - Confluent Surgical, Inc. announced recently that a CE Mark has been granted for the DuraSeal Sealant System for use as a surgical sealant during elective pulmonary resection as an adjunct to standard closure techniques of visceral pleural air leaks. By providing an airtight seal in lung surgery, DuraSeal Sealant will offer surgeons operating on the lung a valuable tool to prevent post-operative complications associated with alveolar air leaks.
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. When sprayed on the pleura, a strong, adherent hydrogel is formed that effectively seals the suture or staple line within seconds. A feature unique to the DuraSeal Sealant is the blue colorant that provides the thoracic surgeon excellent visualization of coverage and thickness of the material upon application to the lung. Postoperatively, the DuraSeal Sealant continues to seal the resected site 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.
"I have worked with other sealants in the past. However, they have not been easy to use and this has limited their adoption. DuraSeal is unique in that it is not only synthetic and elastic, which are important attributes for a lung sealant, but also is extremely easy to prepare and use. This could become an important tool in helping the thoracic surgeon reduce or eliminate airleaks," stated Larry Kaiser, M.D., Chairman of the Department of Surgery at the University of Pennsylvania.
"Each additional day that the patient spends in the hospital due to prolonged airleak can mean thousands of dollars in added expense. An effective lung sealant that can reduce the incidence of prolonged airleak will be a tool that surgeons and hospitals will enthusiastically embrace," said Bryan Meyers, M.D., Division of Cardiothoracic Surgery at Washington University in St. Louis.
"With this approval, DuraSeal will be the only synthetic surgical sealant approved for use in thoracic surgery in the European market. We have been pleased with the successful reception of DuraSeal in neurosurgery and look forward to introducing this unique product to the thoracic surgical community," said Amar Sawhney, Ph.D., Co-Founder, President & CEO of Confluent Surgical.
There are approximately 300,000 lung resection procedures performed worldwide each year and about 80% of these cases result in at least some level of airleak. Additionally, Confluent Surgical currently markets the DuraSeal Dural Sealant System for use as an adjunct to sutured repair of the dura in the several countries including the U.S. and has established an extensive and distinguished neurosurgeon focused distribution channel to represent the DuraSeal product in the U.S. market.
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.
SOURCE: Confluent Surgical, Inc.