New FDA 510(k) Clearance For Tenex Health’s TX1 Tissue Removal System

TENX sell-sheet graphicIn short

California’s Tenex Health has received a new FDA 510(k) clearance for use for its novel TX1 Tissue Removal System. 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.

Background

Tenex Health, Inc. develops and markets innovative therapies for the treatment of tendon pain due to trauma or repetitive motion injuries that affect more than 10 million persons in the US alone every year. The size of a writing pen, 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.

By selectively avoiding damage to surrounding healthy tendon tissue, patients suffer 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.

Tenex Health is currently marketing the TX1 system to address damaged tendon tissue associated with chronic tendonosis pain. 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.

Company comments

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.”

Source: Tenex Health , Inc., Business Wire