LAKE FOREST, Calif.--(BUSINESS WIRE)--Tenex Health has received a new Food and Drug Administration (FDA) 510(k) clearance for use for its novel TX1 Tissue Removal System. The award of this clearance allows the company to use the TX1 System in a broad range of applications and surgical procedures where tissue fragmentation and aspiration is desirable including General Surgery, Orthopedic Surgery, Laparoscopic Surgery, and Plastic and Reconstructive Surgery. The FDA clearance also recognizes the technical components of the TX1 System as single use and completely disposable.
The company is currently marketing the TX1 system to address damaged tendon tissue associated with chronic tendonosis 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. Each year in the United States, over 10 million persons suffer from tendon injuries with associated chronic pain and loss of function. Physicians can now utilize the TX1 Tissue Removal System for removal of pain-generating degenerated tissue and restoration of natural tendon and soft tissue function for their patients.
The scope of the indications awarded in this new FDA clearance allows the company to bring to market technologies within its rich product pipeline. The company is developing minimally invasive instruments and tools that will be used to treat soft tissue damage associated with bursitis (i.e. hip, knee, shoulder), carpal tunnel release and painful post-surgical adhesions.
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. 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.”
About Tenex Health, Inc. Tenex Health, Inc. (www.tenexhealth.com) develops and markets innovative therapies for the treatment of tendon pain due to trauma or repetitive motion injuries. These tendon injuries affect more than 10 million persons in the US alone every year. The company’s proprietary TX1 Tissue Removal System is used to safely and specifically cut and debride diseased soft tissue in an outpatient setting using only local anesthetic (www.fast-technique.com). Since the surrounding healthy tendon tissue is not disturbed, patients enjoy less discomfort and faster recovery times versus traditional open surgical procedures. The one-time procedure is usually completed within 20 minutes and with no need for follow-up treatments.