Tenex Health Lands 510(k) Device Clearance

Tenex Health, of Lake Forest, California, has received 510(k) clearance from the Food and Drug Administration for its TX1 Tissue Removal System. The system is used in surgical procedures where tissue fragmentation and aspiration are required. The company reports that the components of the TX1 System are for single use and are completely disposable.

According to its March 25 press release, the company is currently marketing the TX1 system to address damaged tendon tissue associated with chronic tendonitis pain. The hand-held instrument is the size of a writing pen and allows physicians to deliver ultrasonic energy through a needle that specifically cuts and debrides diseased tendon tissue only. The entire procedure is completed through the use of ultrasound image guidance and in an out-patient setting under local anesthesia in less than 20 minutes. Company officials say that physicians can now utilize the TX1 Tissue Removal System for removal of pain-generating degenerated tissue and to restore natural tendon and soft tissue function for their patients.

Jagi Gill, founder and CEO for Tenex Health, said, “I am particularly excited about this FDA clearance as the expansive indications for use provides us an opportunity to bring our platform technology and product pipeline to the market for other compelling 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. 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.”