The US Food and Drug Administration (FDA) has granted 510(k) clearance to Tenex Health’s TX1 tissue removal system for use in general, orthopedic, laparoscopic, plastic and reconstructive surgical procedures where tissue fragmentation and aspiration is needed.
Using ultrasound image guidance and an outpatient setting under local anesthesia, the device delivers ultrasonic energy through a needle to remove pain-generating degenerated tissue, and restore natural tendon and soft tissue function.
The FDA clearance also recognises the technical components of the TX1 system as single-use and completely disposable, according to the company.
Tenex Health founder and CEO Jagi Gill said the FDA clearanceprovides the company with an opportunity to bring its platform technology and product pipeline to the market for other applications.
"We have observed through the successful launch of our TX1 System to address tendon injuries that the technology delivers a definitive treatment with very little potential for complication," Gill said.
"The technology also allows for consideration of intervention at an earlier date, which reduces the morbidity for the patient and permits a rapid return to full activity.
"The TX1 System provides a unique advantage to both physicians and patients – a procedure that is minimally invasive, safe, effective and with rapid recovery times."
The company is also developing minimally invasive instruments and tools to treat soft tissue damage associated with bursitis (i.e. hip, knee, shoulder), carpal tunnel release and painful post-surgical adhesions.
