TissuePatchDural – New clinical publication in World Neurosurgery

Tissuemed is pleased to announce publication of a new clinical paper in World Neurosurgery relating to its self-adhesive dural sealant film products. This closely follows a recent positive clinical publication in the British Journal of Neurosurgery.

Authored by Dr Paolo Ferroli, Professor Giovanni Broggi and co-workers at the Carlo Besta Institute, Milan, Italy this is a single centre retrospective study detailing 119 consecutive high risk patients who underwent elective neurosurgical procedures between January and June 2010. All patients had received TissuePatchDural (TPD) 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 higher risk for reasons including previous surgery, radiotherapy, long term corticosteroid use and hydrocephalus. Supratentorial, Infratentorial and Spinal patients were included. Overall CSF leak was detected in only 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 at these later stages. In the 22 patients specifically considered higher risk there was a 36.3% of CSF leaks, compared to a 3.1% leak rate in the 97 cases without additional risk. All leaks were treated conservatively and no patient required readmission or repeat surgery. In conclusion, the authors commented “TPD seems to be a safe tool to be used to reinforce dural closure in patients with a high risk of developing CFS leaks.”

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. After only three years since the launch of TissuePatchDural in Europe, 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.”

About TissuePatch and TissuePatchDural The novel technology used in TissuePatchDural is based on the in-situ bonding of synthetic polymers to bodily tissues. The TissuePatch family of products are very thin, synthetic, multilaminate films which bond covalently to amine groups on the surface of internal tissues to provide an air and watertight seal. 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. Tissuemed Ltd also manufactures TPD under the brand name of ObexNeurofilm, distributed exclusively by Medtronic.

About CSF Leakage CSF leak after neurosurgical procedures is variously reported to occur in a range from 0.9% to 42% ( being in specifically higher risk cases ). CSF leak remains a potential life-threatening complication because of the risk of meningitis. Other risks include non healing wounds and prolonged hospitalisation. The medical costs in such cases have been estimated to be 141% greater than in uncomplicated cases.