Polyganics, a company out of Groningen, The Netherlands, won FDA clearance for its NEUROCAP neuroma prevention device. Neuromas are abnormal growths or tumors that grow from nerves, forming painful scars and causing other distress on patients. Treatment usually involves the surgical removal of neuromas and then isolating the nerve ending within tissue not subject to a lot of motion. The NEUROCAP from Polyganics is a small bioresorbable cylinder with a closed end. It’s implanted over a nerve ending where it prevents the formation of a neuroma and eventually gets washed out by the body once the nerve has healed.
Rudy Mareel, CEO a.i. of Polyganics said in a statement, “Neuroma-induced neuropathic pain and morbidity can seriously affect the quality of a patient’s daily life. NEUROCAP, a transparent tubular device with a sealed end, is the first and only synthetic nerve capping device cleared for the management of symptomatic neuromas. Current approaches are based on surgical removal of the neuroma and surrounding scar tissue, then placing the nerve stump in tissue subjected to minimal mechanical stimulation. However, these approaches have in many cases unsatisfactory outcomes. With our bioresorbable medical device NEUROCAP we offer orthopedic and hand surgeons a valuable new tool that contributes to the clinical management of neuromas and that can improve the daily life of patients. Receiving US FDA 510(k) clearance for NEUROCAP is another major milestone for Polyganics.”
Source: Polyganics…