FDA clears Tenex Health's TX1 Tissue Removal System

Tenex Health today announces FDA 510(k) clearance of the TX1 Tissue Removal System. This portable, self-contained system offers precise soft tissue removal for tendons and other soft tissues with intended use in the elbow, knee, ankle, foot, and shoulder. Each year, over 8 million people in the United States suffer from tendon injuries with associated chronic pain and loss of function. Physicians can now utilize the TX1 Tissue Removal System in the FAST procedure—Focused Aspiration of Soft Tissue—for removal of degenerated tissue and restoration of natural tendon and soft tissue function for their patients.

"I am particularly excited about the proposed treatment with ultrasound debridement and aspiration," said Bernard Morrey, MD, University of Texas Health Science Center, San Antonio and Professor Emeritus at the Mayo Clinic. "It offers the possibility of addressing the problem definitively, with very little morbidity or potential for complication. The FAST procedure allows for consideration of intervention at an earlier date, which reduces the morbidity for the patient and allows more rapid return to full activity."

Based on technology developed in collaboration with Mayo Clinic and licensed to Tenex Health, the TX1 System delivers proprietary ultrasonic energy to debride, emulsify, and aspirate degenerated tissue through the pen-like ultrasonic handpiece. The TX1 Handpiece is activated through foot-pedal technology allowing for superb control throughout the procedure. The TX1 System provides a unique advantage to both physicians and patients—a procedure that is minimally invasive, safe, and effective with expected recovery time less than more invasive procedures.

"I am excited about providing a truly innovative technology to address soft tissue injuries for patients under the care of sports medicine or orthopaedic physicians," says Jagi Gill, CEO and founder of Tenex Health. "The TX1 Tissue Removal System is a breakthrough in soft tissue therapies as it provides physicians a tool to remove pain-generating pathologic tissue in a quick and minimally invasive manner."

Tenex Health is preparing for a commercial launch in early Q2 of 2011 in the United States.