Polyganics announced that it is initiating the European launch of its Liqoseal dural sealant patch after it won CE Mark approval.
The Groningen, The Netherlands–based company’s Liqoseal dural sealant patch is designed to reduce cerebrospinal fluid (CSF) leakage following elective cranial surgery.
Liqoseal’s European approval follows the Encase I clinical trial, which revealed an absence of CSF leakage, as confirmed by MRI, no clinically significant swelling and no device-related adverse events after surgery at a three-month follow-up.
Polyganics intends to commercialize Liqoseal in select European countries while growing its network with the addition of distributors throughout Europe in 2020, according to a news release. The company is also planning to launch Liqoseal in select non-European countries as it nears the start of the Encase II randomized controlled trial which Polyganics hopes will propel it toward FDA pre-market approval.
“CSF leakage remains a devastating complication of neurosurgical procedures and represents a significant patient burden with high associated cost,” Polyganics CEO Rudy Mareel said in the news release. “The CE approval of this product is testament to the strength and quality of the clinical data from Encase I, showing that Liqoseal establishes effective and enduring watertight dural closure. This is a key milestone in our journey to deliver our dural sealant patch to surgeons and patients in Europe and ultimately worldwide.”
Original Article: (https://www.massdevice.com/polyganics-liqoseal-sealant-patch-wins-ce-mark-approval/)