We have developed and commercialized three products in the PNR space. Our NEUROLAC® nerve guides are indicated for reconstruction of a peripheral nerve discontinuity up to 20 mm.
Guidance and Protection for Tension-Less Nerve Repairs
Each year an estimated 600,000 complex nerve injuries occur globally. Such injuries can result in long term or permanent difficulties with chronic pain or complete or partial loss of feeling.
Many such peripheral nerve injuries can only be treated through reconstructive surgical procedures. When the nerve ends cannot be rejoined directly using fine sutures without undue tension, nerve grafting or tubulization techniques are required.
For a long time nerve autografting has been used as the standard reconstructive technique for bridging nerve gaps, but the technique has certain disadvantages that may lead to poor functional recovery of patients. Now, due to numerous benefits including ease and speed of treatment and reduced side effects, synthetic and bioresorbable nerve conduits are becoming increasing popular with surgeons.
We offer two nerve guides, NEUROLAC® and NEUROLAC® Thin Wall (TW), which are indicated for reconstruction of peripheral nerve discontinuities of up to 20 mm, typically in the hand and wrist. NEUROLAC® Thin Wall (TW) features a reduced wall thickness to facilitate handling and needle penetration if required. An additional application of NEUROLAC®, NEUROLAC WRAP® is currently being investigated.
Our devices guide and protect nerves as they regenerate from the proximal stump towards the distal, preventing neuroma formation and ingrowth of fibrous tissue to the nerve gap. Such tensionless nerve repair improves healing and function recovery without the need for autologous transplants, reducing operation times and potential for donor site morbidity.
NEUROLAC® and NEUROLAC® TW are fully synthetic, biologically safe and non-immunogenic. They are flexible, allowing easy and comfortable suturing and improving patient comfort, and have sufficient mechanical strength to resist kinking and collapse, enabling early flexion of joints. They are also completely transparent to allow for efficient nerve stump positioning and early observation of blood clots.
Our NEUROLAC® nerve guides provide mechanical support to the healing nerve for a period up to 10 weeks after which they are naturally degraded. The degradation products of our NEUROLAC® tubes are less acidic than those of polyglycolid origin, which benefits the surrounding tissue. Approximately 16 months after implant the nerve guides are completely resorbed, then they are metabolized and excreted safely from the body.
NEUROLAC® TW is the thin-wall version of our unique transparent NEUROLAC® nerve tube concept.
NEUROLAC® and NEUROLAC® TW are commercialized products, available worldwide through our network of distributors.
The use of NEUROLAC® as a ‘wrap-around device’ is currently being investigated in the CONNECT study. Until results of this study have been reported, the use of NEUROLAC® as a wrap-around device is not included in the instructions for use.
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.
|European market||Device class: Class III|
|EC Notified Body||Identification number: 0344|
|US market||Device Class 2; FDA 510(k) number:
K032115 (1,5 – 3mm)
K050573 (4 – 10mm)
|Regulation number||21 CFR 882.5275|
|Establishment registration number||3004504732|
Further information on NEUROLAC®, including technical specifications and regulatory certificates, can be found in our Media centre.