Tenex Health has obtained FDA 510K clearance for its new TX2 MicroTip. The TX2 MicroTip will primarily be utilized to address tendinosis of the shoulder and hip, two areas that were more difficult to reach using the original TX1 MicroTip due to its length.
Tendinosis of the shoulder and hip affects approximately 5 million persons in the US alone every year. The company plans to make the TX2 MicroTip available in mid-2016 as a minimally invasive out-patient solution for patients who suffer from soft tissue pain.
The TX2 MicroTip is a disposable surgical instrument that uses ultrasonic energy to specifically cut and remove targeted soft tissue. The extended length of the TX2 MicroTip, at 2 inches long, will allow physicians to complete a percutaneous tenotomy in regions of the body not typically accessible by the shorter TX1 instrument.
"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," stated Dr. James Andrews of the Andrews Institute.
Dr. Bernard Morrey, Chief Medical Officer of Tenex Health and Past-President of the American Academy of Orthopedic Surgeons added, "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."
Tenex Health develops innovative therapies for the treatment of tendon pain due to trauma or repetitive motion injuries.
The minimally invasive technique utilizes the company’s proprietary TX System designed to cut and remove diseased soft tissue in a minimally invasive outpatient setting. Since the surrounding healthy tendon tissue is not disturbed, patients feel less discomfort and enjoy faster recovery times versus traditional open surgical procedures.