HyperBranch Medical Technology has received 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.
HyperBranch said that Adherus Spinal Sealant simplifies subsequent surgeries acting as an adhesion barrier. The single use device is terminally sterilized and can be applied in both Open and MIS procedures through either a 100mm or 150mm tip.
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. They are stored at room temperature and are delivered to meet the procedure needs.
Currently, HyperBranch has received CE marks for ocular, cranial, and spinal sealants as well as a hernia mesh fixation product. The company has completed a US feasibility study and expects to start the Pivotal portion of the study for the Adherus Dural Sealant. The Spinal product will follow the same approval path in the US.
John Conn, president and chief executive officer, 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 US 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.”