This article is more than 5 years old. Information may no longer be current.
Tenex Health receives 510(k) clearance for surgical instrument for management of tendinosis
Click Here to Manage Email Alerts
Tenex Health Inc. received FDA 510(k) clearance for the TX2 MicroTip for the management of tendinosis of the shoulder and hip.
According to a press release from the company, this disposable surgical instrument uses ultrasonic energy to cut and remove soft tissue. The 2-inch long TX2 MicroTip is longer than the original TX1 and reportedly allows physicians to complete a percutaneous tenotomy in regions that may have been inaccessible with the earlier version of the device.
“The TX1 MicroTip has enjoyed tremendous clinical success in treating over 35,000 patients in the [United States] U.S. since its introduction in 2012,” Bernard Morrey, MD, chief medical officer of Tenex Health, said in the release. “Of these patients, only a small portion have been treated with shoulder or hip tendinosis due to the inaccessibility of the deeper tissues to the TX1 MicroTip. The length and design of the TX2 MicroTip is well poised to effectively treat a large number of patients with a spectrum of conditions in these anatomic areas. We anticipate providing a favorable safety and efficacy profile to a broader group of patients using this ultrasound-guided treatment.”
Reference: