Tenex Health Announces 510(k) US FDA Clearance for TX®-Bone, the Latest in Cutting-Edge Ultrasonic Technology to Help Patients Restore Musculoskeletal Function Without Invasive Surgery
Lake Forest, CA – May 13, 2019 – Tenex Health, Inc., a privately held U.S.-based medical technology company providing healthcare professionals with minimally invasive technologies to treat chronic pain in soft and hard tissue, received 510(k) clearance from the United States Food and Drug Administration (FDA) to commercialize the newest addition to its growing Tenex Health TX® System family, TX-Bone.
TX-Bone is a minimally invasive technology, specifically designed for healthcare professionals to remove pain-causing bone and calcific tissue, thereby helping patients restore musculoskeletal function.
The technology is specifically designed to be used through a small incision, using a very simple, ultrasound or palpation guided technique. This distinctive combination allows physicians to identify and simultaneously perform selective cutting and debriding of pain-generating bone and calcific tissue, with optimized ultrasonic energy.
“FDA clearance for Tenex Health’s new product, TX-Bone, represents a major advancement in the management of patients with tendinopathy, including those who suffer from bony spurs,” said Bernard Morrey, MD of the Mayo Clinic in Rochester, MN. “TX-Bone is extremely efficient for treating soft tissue, but also very effective at removing pain-causing bone and calcific tissue. The data that we have obtained suggests that these additional capabilities have the same benefits and safety of Tenex Health’s other minimally invasive technologies.”
TX-Bone was designed to easily remove painful bone (spur and osteophyte formations) and calcific tissue. Applications include rotator cuff, triceps, the gluteus/trochanteric region, Achilles tendon insertion, Haglund’s deformity, and plantar fascia insertion spurs.
To date, Tenex Health’s TX technology has successfully been used in over 90,000 cases.
Tenex Health will be showcasing its full portfolio of products, including TX-Bone, at the upcoming AOSSM meeting in Boston, MA, July 11-14, 2019 at Booth #330.
About Tenex Health
Tenex Health, Inc. is a privately held medical technology company, focused on delivering healthier and more pain-free lifestyles for active patients. We are able to achieve this by providing healthcare professionals with a cutting edge, minimally invasive technology that eliminates chronic tendon pain, precisely targeting and removing damaged tissue, without the need for conventional surgery. For more information regarding Tenex Health, please visit www.tenexhealth.com.
“TENEX HEALTH® and TENEX HEALTH TX®” are registered trademarks of Tenex Health, Inc.