- Polyganics has received FDA approval for its NEUROCAP neuroma prevention device
- The device is implanted over a nerve ending where it stops the generation of a neuroma
Polyganics, a medical technology company based out of Groningen, The Netherlands, has received FDA approval for its NEUROCAP neuroma prevention device.
Neuromas are tumors that grow from nerves, forming painful scars and causing other problems. The NEUROCAP is a small bioresorbable cylinder with a closed end. The device is implanted over a nerve ending where it stops the generation of a neuroma and finally gets washed out by the body once the nerve has improved.
Rudy Mareel, CEO of Polyganics said, “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.”
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