Polyganics' transparent nerve guide Neurolac receives CE mark

06-Apr-2004

Groningen, The Netherlands. Polyganics B.V. announced Neurolac(R), the only transparent resorbable synthetic nerve guide, received the CE mark.

The most severe form of peripheral nerve damage is transection of the nerve and the consequential loss of nerve function. Although peripheral nerves can regenerate spontaneously, their function is not automatically restored. Formerly the standard surgical treatment for repair of peripheral nerve transection was end-to-end suturing or if the gap is too large the interposition of a nerve transplant from another part of the patient's body. Both techniques are time-consuming, give rise to complications and do not lead to optimal nerve function recovery.

The transparent peripheral nerve guide is a resorbable tube that sutured to both ends of the transected nerve guides the outgrowing nerve in a protective environment, preventing neuroma formation. After the nerve function has been restored, the nerve guide is gradually and completely resorbed by the body. Neurolac has been successfully used in a multi center randomized trial. Use of a nerve guide for peripheral nerve repair especially in handsurgery is rapidly becoming best clinical practice.

Neurolac is now the only transparent nerve guide available to reconstructive plastic surgeons in the EC. Its transparency is considered a tremendous advantage as it allows the surgeon to see what he does and facilitates easy and reliable closure of the nerve gap. Moreover, because of its synthetic character it offers maximum safety to the patient versus animal derived materials.

Sales in the Netherlands are direct to end-users. The company cooperates with specialized distributors which market the product in the EC and in other parts of the world.

Polyganics B.V., a privately held biomedical company based in The Netherlands, markets, develops and manufactures synthetic resorbable break-through solutions to medical needs. Polyganics' products strongly reduce the number of medical interventions and improve patient comfort while lowering health care costs. Neurolac, which already received FDA 510 clearance in the USA, is one of a series of products based on Polyganics' proprietary synthetic resorbable materials. Nasopore(r), a synthetic fragmentable dressing for transient use has been on the market since June 2003.

https://www.bionity.com/en/news/36561/polyganics-transparent-nerve-guide-neurolac-receives-ce-mark.html