HyperBranch Medical Technology, Inc. announced today that the Company has launched Adherus AutoSpray ET Dural Sealant (Extended Tip) into the United States cranial neurosurgery market. This follows approval from the United States Food and Drug Administration (FDA) of a premarket approval (PMA) supplement. The launch of the Adherus AutoSpray ET Dural Sealant applicator allows neurosurgeons improved access and visibility when applying Adherus hydrogel dural sealant.
Combining a proprietary pre-assembled applicator and sealant formulation, Adherus AutoSpray and Adherus AutoSpray ET Dural Sealants significantly advance methods available for neurosurgeons to achieve watertight closure of the dura. The formulation delivered by the Adherus AutoSpray devices is by design a low-swelling, strong, robust barrier that limits CSF leaks while the dura heals. In a prospective, randomized, multicenter clinical trial, Adherus-treated patients experienced fewer CSF leaks that required intervention than patients treated with the control device, DuraSeal Dural Sealant System marketed by Integra Lifesciences Inc. Additionally, there were no device related infections in the Adherus arm as opposed to two device related infections in the DuraSeal arm. Limiting CSF leaks provides a direct cost-benefit to the hospital and is an important factor in the patient’s post-surgical recovery and quality of life.
“The Adherus AutoSpray ET Dural Sealant applicator improves access and visualization of the target site while retaining the other benefits of the AutoSpray applicator such as ease of setup, control of application, and the ability to pause during an application,” said President and CEO Jeffrey Clark. “We are excited about the adoption of Adherus AutoSpray Dural Sealant by many neurological surgery centers across the United States and the addition of this important new product to the portfolio. These centers appreciate that Adherus is an easy-to-use, low-swelling, strong sealant that provides a CSF barrier while the dura heals.”
About Post-Operative Cerebrospinal Fluid Leaks
Avoiding post-operative cerebrospinal fluid (CSF) leaks remains a constant challenge to neurosurgeons. There is considerable morbidity associated with this common adverse event and increased costs associated with additional treatment. The use of a safe and effective dural sealant may reduce adverse events such as CSF leaks and pseudomeningocele; therefore, it reduces patient morbidity and costly treatment. Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant are targeted for use in a variety of craniotomy procedures that breach the dura.