Welcome to the September issue of our LIQOSEAL newsletter
With this newsletter, we aim to keep you as a distributor up to date on LIQOSEAL
What you’ll find in this issue:
- Commercial update and Surgeons’ experiences
- Clinical update: ENCASE II study started; first patients enrolled in US and EU
- New publications: 1-year data ENCASE I published in BMJ open and pre-clinical (ex-vivo) work published in Journals of Material Science: Materials in Medicine
- Our presence at conferences
Thank you for reading our LIQOSEAL newsletter. If you have comments, questions, or we can help further in any way to support enrolment for the study at your clinical centre, please get in touch.
Commercial update and Surgeons’ experiences
We are happy to observe a strong and ongoing growth in the use of LIQOSEAL, to obtain watertight dural closure after cranial surgery. Multiple surgeons replaced Tachosil for LIQOSEAL in supra- and infratentorial neurosurgical cases. According to these surgeons, LIQOSEAL shows advantages in handling and adherence and provides trust in obtaining enduring watertight closure. In addition, surgeons shared numerous ideas for a case-series or trial (ie Tachosil vs LIQOSEAL), based on performance and ease of use. LIQOSEAL has become an essential addition to the neurosurgical toolbox- this includes the LIQOSEAL 5x5cm, offering a price competitive alternative for smaller lesions.
Via our partners we receive a lot of feedback of clinical procedures performed. Please find the endorsements of two surgeons in Spain that recently started with LIQOSEAL below
LIQOSEAL seems surprisingly adherence and gives me confidence. We will continue to use it!
Dr. Jordi Rimbau | Chief of Hospital Germans trías i Pujol of Badalona and Hospital Josep Truena of Girona, Spain
LIQOSEAL is very effective in sealing the dura to avoid CSF fistula , a major cause of disability in neurosurgical patients. It is safe very easy to use and provides a very strong and durable interface while tissue heals. I would strongly recommend their use particularly in redo patients .
Dr Jesus Lafuente | Hospital del Mar Neurosurgery | Barcelona, Spain
Clinical Update: ENCASE II study started: first patients enrolled in US and EU
Following the first patient enrollments in Europe (in USZ-Zürich, UMC Utrecht), we are now proud to announce that the first patients have also been enrolled in the US.
We are delighted with the response and enthusiasm we have seen from participating surgeons. In the video you can hear first-hand from Dr. Andrew Carlson, Neurosurgeon at the University of New Mexico Hospitals in Albuquerque, New Mexico, and Global Coordinating Investigator for the study, why he chose to get involved in ENCASE II.
LIQOSEAL is a potentially game-changing device. This is a unique opportunity to make a meaningful impact for patients
– Dr. Andrew Carlson, Neurosurgeon at the University of New Mexico Hospitals in Albuquerque, and Global Coordinating Investigator for the ENCASE II study
1-year data ENCASE I published in BMJ Open
Polyganics achieved CE mark certification for LIQOSEAL in early 2020, based on positive 3-month data from ENCASE I. 12-month data have now been published in BMJ Open. The ENCASE I trial investigated the safety and performance of LIQOSEAL in reducing cerebrospinal fluid (CSF) leakage following elective cranial intradural surgery. The 12-month data, which was collected at sites in Switzerland and the Netherlands, showed no CSF leakage or clinically relevant swelling in any of the 40 patients enrolled, and no serious device-related adverse events were reported. We asked Dr Tristan van Doormaal, Neurosurgeon at the University Hospital Zurich and University Medical Center (UMC) in Utrecht, Principal Investigator of the study, and leader of the initial research project at the Brain Technology Institute (BTI) to comment on the data and publication:
CSF leakage is a well-known complication of neurosurgical procedures and a significant burden to patients and healthcare systems. LIQOSEAL has proven to significantly reduce CSF leakage compared to standard of care methods. I am pleased to have been involved in the ENCASE I trial and to have played my part in delivering this much-needed device to surgeons. Publication of the data in BMJ Open is recognition of the quality and impact of these results.
– Dr Tristan van Doormaal, Neurosurgeon at the University Hospital Zurich and University Medical Center (UMC) in Utrecht, Principal Investigator of the study, and leader of the initial research project at the Brain Technology Institute (BTI)
Pre-clinical LIQOSEAL data published in Journals of Materials Science: Materials in Medicine
We are happy to announce that the pre-clinical ex-vivo data on LIQOSEAL have been published in the Journal of Materials Science: Materials in Medicine (JMSM). Together with the publications of the ENCASE I protocol and the ENCASE I results, this helps to further strengthen the clinical evidence for LIQOSEAL.
The publication “Ex vivo Evaluation of a Multi-layered Sealant Patch for Watertight Dural Closure: Cranial and Spinal Models” can be found here.*
Liqoseal is capable of achieving a strong watertight seal of a dural defect in conditions simulating cranial and spinal application on the dura. Liqoseal was shown to have a high probability of preventing CSF leakage compared with current clinically used sealants.
Our presence at conferences
We were hoping to meet you all during the The European Association of Neurosurgical Societies (EANS) in October in Hamburg. However unfortunately the EANS has been changed to a virtual session. We will however look for opportunities to meet you soon in any kind of live event.
* Please note – LIQOSEAL is not intended for use in the spine: LIQOSEAL 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 cerebrospinal fluid (CSF) leakage. For more information, please read the Instructions for Use
