HyperBranch wins CE mark for Adherus spinal sealant
A Medical Device Daily Staff Report HyperBranch Medical Technology (Durham, North Carolina) has received a CE mark for Adherus spinal sealant, which is used in spinal surgeries where a water tight seal is required to prevent cerebrospinal fluid leakage from the dural repair. Prevention of cerebrospinal fluid leaks should benefit the patient in shorter hospital stays and fewer postsurgical complications such as reduced pain and fewer infections. Adherus also acts as an adhesion barrier, thereby simplifying subsequent surgeries should the need arise, the company said.
“Adherus spinal sealant is an easy to use device that complements HyperBranch’s neurosurgical sealant product line. Adherus dural sealant, which was first launched in 2009, is currently marketed outside the U.S. for cranial surgery. The spinal sealant has negligible swelling, degrades slowly [and] not only provides a watertight seal, but also acts as an adhesion barrier to limit scarring, a major advantage if subsequent surgery is required,” said John Conn, president/CEO.
The single-use device is terminally sterilized and can be applied in both open and MIS procedures through either a 100 mm or 150 mm tip. The CE mark provides regulatory approval for the company to begin sales in Europe and other countries outside the U.S.
The Adherus products are synthetic hydrogels which polymerize in a moist field, flow optimally depending on the application, and are biodegradable as the tissue reestablishes itself. The biocompatible composition is stored at room temperature and is delivered through a custom applicator to meet the specific needs of the procedure.