Ivy Sports Medicine Announces the First U.S. Implantation of its Collagen Meniscus Implant
Ivy Sports Medicine announced the first U.S. implantation of its Collagen Meniscus Implant (CMI), a biocompatible scaffold made of highly purified collagen that can be used to reinforce and repair a meniscus defect following partial meniscectomy or for irreparable meniscus tears.
CMI provides surgeons with a new option when faced with an irreparable meniscus tear or a failed meniscectomy that results in segmental loss of meniscal tissue. The implant has the general shape of the human meniscus and is trimmed by the surgeon to match the size of the patient’s meniscal defect. It is inserted by utilizing a minimally invasive procedure and sutured in place to the native meniscus.
The product was initially developed by ReGen Biologics and had received CE Mark certification in 2000. The implant first received FDA approval in 2008 after ReGen had been at odds with the FDA over the appropriate marketing pathway for product which was call Menaflex at that time. The FDA however, conducted a follow-up investigation on the product as it had been reported that questionable conduct might have taken place during the trial and had influenced the decision. The FDA ended up rescinding its market clearance of Menaflex in 2010. As ReGen was filing for bankruptcy however, the company sued the FDA on its decision. ReGen Biologics was then acquired by Ivy Sports Medicine in 2011, and Menaflex continued under the company as CMI. Ivy eventually won the suit filed by ReGen in 2014, and therefore the implant once again, had clearance to be marketed on the U.S. market.
CMI will officially be introduced at this year’s Arthroscopy Association of North America (AANA) Fall Course in Dallas, TX. The surgery was performed by Dr. Wayne Gersoff, in Denver, CO.
Originally posted on: Healthpointcapital.com