Polyganics NEUROLAC - Adapting Versatile Polymers
Synthetic nerve guides are indicated for reconstruction of peripheral nerve discontinuities up to 20 mm.
- Synthetic material; co-polymer of lactide and caprolactone; these are well known biocompatible and safe polymers
- Transparency of the device, facilitating optimal nerve stump positioning and easy detection of blood clots, preventing growth of nerve fibers
- Degradation at a predictable rate, supporting axon gap regeneration up to 20 mm
- Controlled mechanical strength and flexibility for a period of 10 weeks, preventing kinking and collapsing of the tube during the critical recovery period
The Birmingham Hand Centre, part of the NHS’s Queen Elizabeth Hospital in Birmingham, a leading UK center in hand and reconstructive surgery, is currently investigating the use of NEUROLAC® in tensionless repair. The CONNECT (COnduit Nerve approximation versus Neurorrhaphy Evaluation of Clinical outcome Trial) study assesses the advantages of using a nerve conduit in addition to microsurgical neurorrhaphy, or nerve suturing for recovering sensitivity of injured fingers. Three arms are being investigated; direct suturing, direct suturing combined with NEUROLAC® as wrap around, and tensionless repair with a 3-5 mm gap, with NEUROLAC® as a connector. Final data are expected in 2020.
Our quality management system is ISO13485:2016 certified by Dekra Certification BV, a standard for quality management systems for design, manufacturing and distribution of medical devices. We also comply with the USA FDA 21 CFR 820 corresponding subparts and other applicable regulatory requirements for medical devices.
NEUROLAC nerve guide is composed of the bioresorbable copolyester poly(DL-lactide-?caprolactone). NEUROLAC provides guidance and protection to regenerating axons. NEUROLAC elicits a minimal acute inflammatory reaction of the surrounding tissue, which is followed by gradual encapsulation of the tube by fibrous tissue. Degradation of NEUROLAC occurs through hydrolysis leading to gradual reduction of molecular weight. NEUROLAC retains its initial mechanical properties up to at least 8-10 weeks, whereafter rapid loss of mechanical strength and gradual mass loss occur. NEUROLAC nerve guide is resorbed within approximately 16 months. Expected device lifetime is 24 months if stored between -18°C and 8°C.
NEUROLAC nerve guide is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve. NEUROLAC is a bioresorbable product that will be completely resorbed in time and is not influenced by the behavior of the patient prior or following the surgery.