Tenex Health wins 510(k) for TX2 MicroTip

Tenex Health said today it won FDA 510(k) clearance for its TX2 MicroTip designed to treat tendinosis of the shoulder and hip.

The Lake Forest, Calif.-based company said that the new TX2 MicroTip is 2 inches longer than the previous TX1 incarnation, allowing for easier access to both the shoulder and hip.

“The TX System using the TX1 MicroTip has been used by physicians for the past few years and demonstrated to be effective in treating chronic tendinosis in a variety of body parts. The longer needle associated with the TX2 product will provide physicians the needed technology to definitively treat chronic tendinosis in the shoulder and hip. Soft tissue injuries in both of these body parts are well suited to be treated through a minimally invasive approach using the TX2 product,” Dr. James Andrews of the Andrews Institute said in a press release.

The TX2 MicroTip is a disposable device that uses ultrasonic energy to cut and remove targeted soft tissue. The company said the length of the device will allow physicians to complete percutaneous tenotomies in regions previously not accessible by the earlier, shorter version.

“The TX1 MicroTip has enjoyed tremendous clinical success in treating over 35,000 patients in the US since its introduction in 2012. 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,” CMO Dr. Bernard Morrey said in a prepared statement.

The post Tenex Health wins 510(k) for TX2 MicroTip appeared first on MassDevice.

from MassDevice http://ift.tt/22Ltl4b