Tissuemed praised in Clinical paper

19/10/2010

Clinical evidence published in the British Journal of Neurosurgery reveals TissuePatchDural - a surgical product developed and manufactured by Leeds based Tissuemed – prevents leaks during surgery, reduces surgery time and offers clinicians improves results.

The clinical study was carried out by neurosurgeons at the University of Padova, Italy, on 12 patients, who all had a high risk of developing Cerebrospinal Fluid (CSF) leakage - the fluid in which the brain and spinal cord is situated - post operatively.

CSF leakage through the Dura, the covering over these tissues, is a recognised complication following brain and spinal surgery, with consequences such as prolonged patient stay in hospital and risk of related problems for the patient, such as infection and sometimes even the need for additional operations. 

TissuePatchDural is a very thin membrane, best thought of as a sort of self adhesive ‘clingfilm’ to seal the tissue against fluid leakage, before eventually being absorbed by the body.

During the course of this 12 patient series, the authors used TissuePatchDural when water-tight closure of the Dura had not been achieved through traditional closure means.

Patients were then followed up over a 5 to 9 month period, where clinical and neuro-radiological examination showed no evidence of CSF leak in any patient and no device-related adverse events. 

One of the authors, Dr Della Puppa explains in the paper: “TissuePatchDural is a sealant, like biological glues, but unlike them it is a large film able to cover large dural surfaces affected by multiple defects. Moreover, the application does not take time to be prepared, as with biological glues. In our current dural defect management in selected patients the use of TissuePatchDural has reduced time of repairing and improved final results”.

Dr David Mandley, Tissuemed’s director responsible for clinical affairs commented, “This independent, surgeon led study provides an excellent demonstration of the effectiveness, ease of use and safety of TissuePatchDural as a Dural sealant.  I expect this paper to be the first in a series of publications describing the clinical use of this novel surgical sealant film.  Furthermore, it is very well timed as it is also applicable to ObexNeuroFilm, an equivalent product that from 1st September is being distributed exclusively by Medtronic our recently announced distributing partner”.
 
The clinical paper is being published in the British Journal of Neurosurgery, October 2010; 24(5): 609–611. 

More information about Tissuemed

Tissuemed, based in Leeds, UK, is a leading medical device company with a reputation for technical innovation dating back over twenty years. The company has its origins in the development of tissue-based therapeutic devices including developing the first tissue heart valve to gain regulatory approval in Europe, subsequently developing "living" vascular grafts and collagen patches. The company developed light-activated surgical adhesives for which Tissuemed was the Gold Winner of the Medical Design Excellence Award in 2001.

For more information contact Julia Price, Medilink Yorkshire and Humber:
Tel:  +44 114  2329281
E-mail: j.price@.medilink.co.uk