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Bioresorbable polymer-based nerve capping device receives FDA 510(k) clearance

Netherlands-based Polyganics (Groningen), a medical technology company that has developed multiple polymer platforms to support the design and manufacture of bioresorbable medical devices, announced today that it has received 510(k) clearance from FDA for a device that reduces neuroma formation. A transparent tubular device with a sealed end, Neurocap reportedly is the first and only synthetic nerve capping device cleared for the management of symptomatic neuromas.

Neuroma is described as a benign growth of nerve tissue that can cause pain, a burning sensation, tingling or numbness. The condition is often referred to as a pinched nerve or nerve tumor. Approximatly 600,000 nerve repair procedures are performed annually in the United States, according to Polyganics, and approximately 3 to 5% of patients develop symptomatic neuroma. Also, 185,000 persons undergo amputations of a limb each year, and 20% of those will develop symptomatic neuromas. Neurocap is intended to be used for neuromas that occur after nerve repair and for amputation stump neuromas.

"Neuroma-induced neuropathic pain and morbidity can seriously affect the quality of a patient's daily life," said Polyganics CEO Rudy Mareel in a prepared statement. 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, he explained. "However, these approaches have in many cases unsatisfactory outcomes. With our bioresorbable medical device, 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," said Mareel.

Previously, Polyganics developed a portfolio of products based on its proprietary polymer platform technologies for ear, nose and throat surgery, which it sold to Stryker in 2014. It continues to manufacture these products for Stryker under the terms of the agreement.

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