Local Tech Wire

DURHAM, N.C – said Tuesday it has received a CE Mark for its Adherus Spinal Sealant, providing regulatory approval for the company to begin sales in Europe and other countries outside the U.S.

Adherus Spinal Sealant 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 post-surgical complications such as reduced pain and fewer infections.

Adherus Spinal Sealant also acts as an adhesion barrier, thereby simplifying subsequent surgeries should the need arise. The unique, single use device is terminally-sterilized and can be applied in both Open and MIS procedures.

The device complements HyperBranch’s neurosurgical sealant product line. First launched in 2009, Adherus currently is marketed outside the U.S. for cranial surgery. Adherus 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, explained John Conn, HyperBranch’s president and CEO.

The Adherus products are synthetic hydrogels which polymerize in a moist field, flow optimally depending on the application, and are bio-degradable as the tissue re-establishes itself. The biocompatible composition is stored at room temperature and is delivered through a custom applicator to meet the specific needs of the procedure.

HyperBranch Medical Technology, Inc. has now received CE Marks for ocular, cranial, and spinal sealants as well as a hernia mesh fixation product. The spinal product will follow the same approval path in the U.S.

(Editor’s Note: The CE marking is an acronym for the French "Conformite Europeenne" which certifies that a product has met EU health, safety, and environmental requirements.)

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