Tenex Health Inc. recently announced the completion of a clinical evaluation of the FAST procedure—Focused Aspiration of Soft Tissue—utilizing the TX1 Tissue Removal System’s second-generation TX1 MicroTip. The FAST procedure uses proprietary ultrasonic energy to precisely debride, emulsify, and aspirate degenerated tissue in tendons and other soft tissues through the pen-like ultrasonic TX1 MicroTip. The second-generation MicroTip provides a percutaneous needle-like tip that is two times the length of the original tip, providing greater and easier access to targeted tissues. Along with its accompanying cartridge and collection bag, the second generation TX1 MicroTip is completely disposable. Investigators view it as a breakthrough in performing tissue removal procedures with efficiency and precision with little to no discomfort to the patient. “The FAST procedure appears to hold the possibility that we can treat one of the most common afflictions of the elbow in a definitive manner, and we can offer this treatment justifiably early in the course of the disease process,” said Bernard Morrey, MD, lead investigator of the clinical evaluation. Dr. Morrey is emeritus chairman and professor of Orthopedics at Mayo Clinic and the University of Texas Health Science Center, San Antonio. “In our experience, the technology was seen to be safe and provided no discomfort to the patients during the procedure. The initial clinical results are very impressive, and if the evidence for safety and efficacy continues to develop, this is a real game-changer.”
Ranging in age from 33 to 50, 10 patients (six men/four women) with chronic elbow pain lasting for at least three months participated in the evaluation. In addition to symptoms consistent with tendinosis, all patients underwent a diagnostic ultrasound that revealed damaged tendon. With ultrasound guidance, patients were treated with the TX1 MicroTip under local anesthesia to remove the damaged and diseased tendon tissue. Pain scores (VAS), disability/quality of life measures (DASH), adverse events, and total procedure times were captured at baseline and one month. No physical therapy or medication was used during this period. A summary of the clinical results is provided below:
• All patients pain-free at one month (average pain score reduced from baseline of 6 to 2.7)
• Significant improvement in disability/quality-of-life measures (over 50% absolute change)
• No device or patient complications
• Total procedure time (cleaning skin to adhesive bandage placement) under 13 minutes
• Total FAST energy time of 35 seconds (average)
“We now have a safe, painless, effective, and very minimally invasive treatment for epicondylitis, commonly known as tennis or golfer’s elbow,” said Darryl E. Barnes, MD, staff physician in the Department of Orthopedics and Sports Medicine, Austin Medical Center in Minnesota. “I was impressed to see that the tissue removal portion of the procedure typically took 30 seconds.”
“I am very excited about the advancements we have made with the TX1 Tissue Removal System and the FAST Procedure,” says Jagi Gill, CEO and founder of Tenex Health. “The results of this clinical evaluation demonstrate the benefits of the improved technical design. It has shown that we are able to deliver an effective treatment with tremendous ease of use for physicians coupled with comfort and rapid return to activity for patients. This also provides us a solid foundation to pursue treatments of other joints.
Tenex’s technology has been FDA approved and is being rolled out in USA this year. There is no suggestion of European launch date nor gaining of CE mark at this time.
Source: Tenex Health