LEEDS, England, January 31, 2012 /PRNewswire/ --
UK surgical sealant film company Tissuemed Ltd. has announced the publication of a new clinical paper in World Neurosurgery relating to its self-adhesive dural sealant film products.
Authored by Dr Paolo Ferroli, Professor Giovanni Broggi and co-workers at the Carlo Besta Institute, Milan, this is a single centre retrospective study detailing 119 patients who underwent elective neurosurgery. All patients received TissuePatchDural to reinforce dural closure following identification of a CSF leak after routine microsuture closure.
This was a mixed population of patients including 22 assessed as being high risk for reasons including previous surgery, radiotherapy, long term corticosteroid use and hydrocephalus. Supratentorial, Infratentorial and Spinal patients were also included. Overall CSF leaks were detected in 11 of the 119 patients (9.2%), all occurring within two weeks of surgery. Patients were additionally assessed at 2 and 6 months following treatment and none were found to be suffering CSF leakage.In the 22 patients considered high risk there was a higher (36.3%) percentage of CSF leaks, compared to a 3.1% leak rate in 97 cases without additional risk. All leaks were treated conservatively and no patient required readmission or repeat surgery. In conclusion, the authors commented "In our experience the product appears to be safe and no adverse reaction was evident throughout the study. Results in terms of CSF leak prevention are promising."
Dr David Mandley, Tissuemed's CEO, commented: "This latest paper, the third in 12 months published by European Neurosurgeons, represents the largest patient cohort receiving TissuePatchDural to be investigated and reported to date. As we approach four years since the launch of TissuePatchDural I'm delighted to have such positive clinical experience and published data from the Carlo Besta Institute, a highly regarded and world renowned centre of excellence in the field of neurosurgery."
The technology used in TissuePatch products is based on the in-situ bonding of synthetic polymers to bodily tissues. The products are thin, synthetic, films which bond covalently to amine groups on the surface of internal tissues to provide a watertight seal. As such these films are used as an adjunct to traditional suturing or stapling in a variety of surgical procedures where achieving a secure closure is paramount.
The data also supports use of TissuePatchDural's sister product ObexNeurofilm™, which is distributed by Medtronic's Neurosurgical Technologies Division
SOURCE Tissuemed Ltd