Polyganics' NEUROCAP receives FDA 510(k)
vrijdag 29 januari 2016
Polyganics announced it has received FDA 510 (K) clearance for NEUROCAP. This is an innovative device, designed to reduce painful neuroma formation. Thereby it facilitates tissue repair and regenaration.
Rudy Mareel, CEO a.i. 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.”
Polyganics, a privately held medical technology company focused on the commercialization of proprietary products and technologies for peripheral nerve repair, neurosurgery, general surgery, as well as ear, nose & throat surgery.
NEUROCAP is available in the USA through MicroAire Surgical Instruments LLC (www.microaire.com), the exclusive distribution partner of Polyganics’ PNR portfolio for the USA, Canada and Puerto Rico.
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