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June 2011

Viewing posts from June , 2011

Nextremity Solutions™ Obtains FDA Clearance for Nextra™ Hammertoe Correction System

Nextremity Solutions, LLC announced it has obtained FDA clearance for its NEXTRA™ Hammertoe Correction System. The NEXTRA System is a key component to the company’s forefoot reconstruction portfolio. Nextremity Solutions co-founder, Dr. Stuart Katchis, MD observed that “Despite the high volume of hammertoe procedures performed in the US, there are few options available to surgeons and their patients for the correction of hammertoes. Currently available treatments for hammertoes provide inconsistent results. I believe that the Nextra System is the first device to address the key issues that lead to suboptimal outcomes and we expect the Nextra Hammertoe Correction System to offer a marked improvement over traditional hammertoe surgeries.” A recent independent medical device research report estimates that the hammertoe deformity affects between 30 to 60 million of the US population. Of these, only 1.5 million patients are diagnosed annually and merely one third of those have surgery. An increasing number of surgeons and patients are adopting implants for hammertoe correction over Kirschner wires (K-Wires). K-wire procedures require that the wires to protrude through the toes during the first six weeks of healing making K-wire uncomfortable and undesirable for patients. Arthur Alfaro, President & CEO, commented that, “The FDA clearance marks another important milestone for Nextremity Solutions. It is exciting to participate in such a dynamic market where there is a great opportunity for innovative products like the Nextra Hammertoe Correction System and the other products in the Company’s development pipeline. We consider this our first step in delivering the highest levels of quality and innovation to the rapidly growing foot and ankle surgery market.” About Nextremity Solutions, LLC Nextremity Solutions is a privately held medical-device company offering a novel approach to the surgical correction of small bone deformity, degeneration and trauma, founded by surgeons who are committed to the development of medical implants that will provide repeatable and superior patient outcomes. Nextra™ Hammertoe Correction System and Nextra™ Hammertoe Correction Implant are trademarks of Nextremity Solutions, LLC. For further information, visit www.nextremitysolutions.com or call 574-635-3023.