Trice Medical has received FDA 510(k) Clearance for the Tenex® 2nd Generation System, featuring a revamped console with improved usability and durability while expanding the available length of the MicroTip for use in deeper tissue applications. Tenex 2nd Generation takes the treatment of chronic refractory tendinopathy, bone spurs, and diabetic foot ulcers to the next level.
MALVERN, Pa., Dec. 4, 2024 /PRNewswire-PRWeb/ -- Trice Medical has received FDA 510(k) Clearance for the Tenex® 2nd Generation System, featuring a revamped console with improved usability and durability while expanding the available length of the MicroTip for use in deeper tissue applications. Tenex 2nd Generation takes the treatment of chronic refractory tendinopathy, bone spurs, and diabetic foot ulcers to the next level.
"The Tenex technology was truly transformative, allowing for safe and effective treatment of multiple challenging musculoskeletal pathologies in a precise and efficient manner," said Dr. Mederic M. Hall, Sports Medicine Physician at the University of Iowa Healthcare. "This 2nd Generation device will allow us to further move the field of ultrasound guided surgery forward with more efficient treatment and expanded applications. Years of user and patient feedback have informed substantive improvements in a device that has already shown significant clinical benefit. This is an exciting time for those of us helping patients with chronic tendinopathy."
Launched in 2012, the predicate Tenex Health TX® System established a breakthrough standard of care for tendon disease through effective and early intervention. Today, over 200,000 patients have been treated. Tenex technology is well supported by more than 90 independent, peer-reviewed studies and articles in medical journals, showing ≥ 85% clinical efficacy in soft tissue.
"Tenex technology is validated by its wide adoption and has proven to be a trusted standard of care for its indicated uses," said Mike Steen, President and Chief Operating Officer at Trice Medical. "While the modes of action in the 2nd Generation remain substantially equivalent to the legacy Tenex system, we have now developed a more advanced, dynamic platform that will enable the technology to go even further."
"Dancers and athletes have short off-seasons, and Tenex provides a definitive solution for getting back quickly. The longer MicroTips broaden treatment possibilities for all my patients with varied body types," said Dr. Julia L. Iafrate, Sports Medicine Physician and tendinopathy specialist at NYU Langone Health. "Tenex is a powerful tool that has also helped my firefighter and first responder patients perform at their very best, individuals who truly hold our lives in their hands."
Tenex 2nd Generation will soon launch in a limited user release, with wider commercial availability planned for later in 2025.
About Trice Medical:
Trice Medical, in Malvern, PA, and Lake Forest, CA, is a leader in minimally invasive medical technologies. The company offers innovative and clinically proven solutions that allow physicians the flexibility to treat in a procedure room, ambulatory surgery center, or hospital setting. Trice Medical's portfolio includes Seg-WAY™ Endoscopic Release Systems and Tenex® for treating chronic tendinopathy and bony prominences, including diabetic foot ulcers. More information is available at https://tricemedical.com.
Media Contact
Lyly Hoang Wight, VP Marketing, Trice Medical, 1 (610) 989-8080, [email protected], https://tricemedical.com
SOURCE Trice Medical; Trice Medical
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