FDA Clears New Soft Tissue Debridement Tool
TendoNova Corporation, specializing in microinvasive sports medicine procedures, has received U.S. Food and Drug Administration (FDA) clearance for its new microinvasive Ocelot surgical tool.
The tool can be used for the fragmentation or debridement of soft tissue.
The company says it is changing the treatment game for tendinopathy which includes chronic pain conditions like tennis elbow, plantar fasciitis, and jumper’s knee. These conditions are prevalent in professional athletes, weekend warriors, and anyone who engages in repetitive tasks.
With more than 30 million people in the U.S. suffering from chronic tendon pain and half of those having little to no relief from current treatment options, this new tool could be a game changer. The FDA found it to have improved clinical outcomes, decreased cost of care and improved patient and physician experience.
The FDA said that the Ocelot TDS 1000 was equivalent to the Tenex TX1 which was recently acquired by Trice Medical. Tenex TX1 is used for percutaneous tenotomy in orthopedics, sports medicine, pain management, and podiatry.
The Ocelot system’s form factor and price point make it an exciting alternative to existing tools, TendoNova said.
The new tool uses technology licensed from Georgia Institute of Technology and Emory University School of Medicine. It will facilitate procedures that require fragmentation and debridement of soft tissue under external image guidance in a simple hand-held format.
The Ocelot was developed through grants and investor backing of groups such as the Georgia Research Alliance and the National Football League Players’ Association.
“The Ocelot is the company’s first product and was conceived in response to a request by Atlanta Hawks head team physician Dr. Ken Mautner for an improved tool,” said TendoNova CEO Mark A. Samuels.
Dr. Mautner, who practices at Emory, added, “After 15 years of treating elite and recreational athletes for tendinopathy, I have been frustrated by the tools we have had to help heal these injuries. The TendoNova device could be a game changer in getting our athletes back to the healthiest level possible.”
Mechanical fragmentation or debridement of a targeted area is a common way to treat painful pathologic tendon tissue, which if left untreated, can lead to months or years of pain and even career-ending injuries.
TendoNova plans to manufacture the Ocelot in Georgia. It is expected to be available to physicians in the second half of 2022.