TAGS: Sealants
Polyganics has received CE Mark Certification for LIQOSEAL® in reducing cerebrospinal fluid (CSF) leakage following elective cranial surgery, under the ENCASE I clinical trial. The 3-month results of ENCASE I show the absence of CSF leakage as confirmed by MRI, no clinically significant swelling, and no device-related adverse events following surgeries that used LIQOSEAL® for dural closure. Polyganics has submitted its filing for the CE Mark of LIQOSEAL® based upon these positive data from the ENCASE I trial.
LIQOSEAL®- Easy-to-use Clinical Sealant
LIQOSEAL® is a safe, synthetic, easy-to-use dura sealant patch, developed using Polyganics’ proprietary bioresorbable polymer technology, already applied worldwide in multiple clinical areas. The patch is indicated for use as an adjunct to standard methods of cranial dural repair to provide a watertight closure of the dura mater and reduce CSF leakage. In vivo studies showed that LIQOSEAL® also supports the regeneration of the dura mater during the critical healing period, by acting as a scaffold for new fibrotic layer formation (‘neodura’).
Key Features of LIQOSEAL®
CSF leakage remains a devastating complication for neurosurgical patients. The follow-up results from ENCASE I support previous in vitro and in vivo observations and indicate that LIQOSEAL® is safe to use in patients and seemingly shows better reduction of CSF leakage over standard of care methods as referred to in clinical literature. The unique scaffolding characteristic of the purely synthetic resorbable product, promotes the formation of a new layer of native dura, the layer that surrounds the brain and the spinal cord and which is responsible for keeping in the cerebrospinal fluid.
The submission of LIQOSEAL® for CE marking is another important step towards commercializing the product. Following CE approval, Polyganics plan to launch LIQOSEAL® in several countries across Europe, and ultimately plan to submit the product for pre-market approval (PMA) to the US Food and Drug Administration.
Source: Polyganics