Welcome to the first issue of our LIQOSEAL® – ENCASE II Clinical Study newsletter.
LIQOSEAL® is the first product in our Neurosurgery portfolio. The easy-to-use dural sealant patch is indicated for use as an adjunct to standard methods of cranial dural repair, to provide watertight closure of the dura mater and reduce cerebrospinal fluid leakage.
Based on the results of our ENCASE I clinical study, LIQOSEAL® achieved CE-mark certification in January 2020. Now, just over a year after launch, LIQOSEAL® is commercially available throughout Europe via a network of renowned distributors, and uptake of the device is accelerating, with several centres now using our patch as their standard of care for dural closure.
Outside Europe, we are in the (registration) process of making LIQOSEAL® available in other countries, including Australia, Israel and Argentina in the near term.
We recently added a new size of patch (5x5cm) as well to the current patch (8x8cm). Surgeons can use this 5x5cm patch for smaller incisions and closures that only need a minor adjunct.
The next step for LIQOSEAL® is the ENCASE II study, which will enable us to submit the device to the FDA for Premarket Approval. ENCASE II is a randomized, two-arm, multicenter study, evaluating the safety and efficacy of LIQOSEAL® in reducing CSF leakage following elective cranial surgery.
With this newsletter, we aim to keep all participating clinical centers regularly updated with the latest information on this trial.