In short
Back in 2009 HyperBranch Medical Technology, Inc. gained CE mark approval for use of its Adherus™ adhesive hydrogel as a dural sealant. The following year it gained approval for use in spinal cases. Now the company has announced that it has received CE Marking for Adherus AutoSpray Dural Sealant. Adherus AutoSpray is a novel delivery system used for the delivery of HyperBranch’s dural sealant which is used in cranial and spine surgeries to prevent cerebrospinal fluid leaks following the dural repair.
Background
Prevention of cerebrospinal fluid leaks is a key goal for neurosurgeons as leaks are typically sustained and can result in post-surgical complications such as infection resulting in extended hospital stays or even return to hospital.
Surgeons employ a number of techniques in an attempt to minimise leakage, starting with precise suturing, but in many cases, especially in the posterior fossa or skull base surgery this is not adequate and other products including Covidien’s Duraseal, Medtronic’s Obex Neurofilm or Tissuemed’s analogous TissuePatch are employed. Adherus is a purpose-designed synthetic hydrogel which polymerises in a moist field and biodegrades as the tissue heals. Adherus Autospray is an applicator which the company claims permits easy coating of the target tissue without the problem of clogging.
The CE Mark provides regulatory approval for the company to begin sales in countries outside the U.S.
Company comments
“Adherus AutoSpray is the first self-contained bioadhesive spray applicator that eliminates cumbersome preparation steps for the scrub nurse and allows the surgeon to effortlessly and precisely start and stop dispensing without concern for clogging. It complements the Company’s other neurosurgery products: Adherus Dural Sealant and Adherus MIS. All the Company’s products share the same proprietary chemistry that provides controlled performance while degrading slowly during the healing process. It not only provides a watertight seal but acts as an adhesion barrier to limit scarring, a major advantage if subsequent surgery is required,” said John Conn, President and Chief Executive Officer.
Regulatory status
HyperBranch Medical Technology, Inc. has now received CE Marks for five of its products. The Company has completed a U.S. feasibility study and is nearing completion of the pivotal portion for its cranial product which includes the new AutoSpray device.
Source: HyperBranch Medical Technology, Inc., Business Wire
published: May 16, 2012 in: Approval/Clearance, Neuro