HyperBranch Medical Technology has announced that it has received a CE Mark for Adherus Spinal Sealant. 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 sterilised and can be applied in both open and minimally invasive surgery procedures through either a 100mm or 150mm tip. The CE mark provides regulatory approval for the company to begin sales in Europe and other countries outside the USA. “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 USA for cranial surgery. Adherus Spinal Sealant has negligible swelling, degrades slowly 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 and CEO.
The Adherus products are synthetic hydrogels which polymerise 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 has completed a USA feasibility study and is starting the Pivotal portion of the study this month for the Adherus Dural Sealant. The Spinal product will follow the same approval path in the USA.