WALTHAM, Mass., Dec. 3 /PRNewswire/ -- Confluent Surgical, Inc. today announced that the Neurological Devices Advisory Panel voted to recommend to the U.S. Food and Drug Administration (FDA) the approval of the DuraSeal(TM) Dural Sealant System as an adjunct to sutured dural repair during cranial surgery to achieve watertight closure. The Panel recommended approval with conditions relating primarily to a post-approval study and language in the product labeling information for physicians.
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 minutes. When sprayed on tissue, a strong, adherent hydrogel layer is produced, effectively sealing the suture line. The hydrogel 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. Clinical results presented to the Neurological Devices Advisory Panel by Confluent Surgical demonstrated that DuraSeal was able to achieve watertight closure in 98% of cases where it was applied on a sutured dural repair. In 95% of cases, immediate sealing was obtained on the first application, and 95% of applications were rated as "easy to very easy" by neurosurgeons using the product.
"These data demonstrate that DuraSeal has the potential for providing a new paradigm for how the dura is closed following cranial surgery. Watertight closure has to date been an elusive goal and for the first time, it can become reality," said Harry van Loveren, MD, Chairman of the Department of Neurosurgery, University of South Florida, and a principal investigator in the pivotal DuraSeal multi-center study.
"The recommendation of the committee is an important step toward offering a highly effective new tool to neurosurgeons in the U.S. The trial data has shown that sutured repair is almost never watertight and DuraSeal can enable the surgeon to make those repairs watertight in almost all cases," said Amar Sawhney, President and CEO for Confluent. "We will continue to work closely with FDA officials to complete the review of our PMA application."
"This is a remarkable product and I look forward to using the dural sealant as the first FDA approved product for the unmet need for achieving a watertight dural closure," said G. Rees Cosgrove, MD, Associate Professor of Surgery, Harvard Medical School, Massachusetts General Hospital.
There are approximately 250,000 craniotomies performed in the U.S. each year and almost all cases involve a sutured repair of the dura. This recommendation by the Neurological Devices Advisory Panel, although not binding, will be considered by FDA in its final review of the DuraSeal pre- market approval application (PMA). The Panel that reviewed the application is composed of experts in the field of neurology and neurosurgery and is convened by the FDA to provide expertise and advice related to the review of devices used in neurology and neurosurgery.
For additional information, please contact Roberta Sawyer at email@example.com or visit the Confluent Surgical and DuraSeal website at http://www.confluentsurgical.com/ or http://www.duralsealant.com/
Confluent Surgical, Inc.