EDINA, Minn.–(BUSINESS WIRE)–Tornier, Inc., a global leader in extremities and sports medicine orthopaedics, and LifeCell™ Corporation, a KCI Company (NYSE: KCI – News), announced today the first 13 patients have been enrolled in a multi-center clinical trial to document the clinical value of Conexa™ Reconstructive Tissue Matrix for the surgical repair of large rotator cuff tears. Conexa™ is a porcine-derived tissue matrix with both biologic and mechanical properties that are important to support the repair of injured or surgically reconstructed soft tissue. Launched by Tornier for orthopaedic applications in October of 2008, Conexa™ has been used successfully in approximately 1,500 patients.
The primary objective of the 65 patient, prospective Conexa™ clinical trial is to assess clinical outcomes following the surgical repair of large rotator cuff tears. In conjunction with these surgical procedures, Conexa™ is being utilized to reinforce the patient’s rotator cuff tissue that, especially in the case of large tears, may be atrophied or otherwise compromised. The primary clinical results of the study will be determined by comparing the pre-operative and post-operative measurements of functional metrics utilizing shoulder outcome scores. We will also be reviewing rotator cuff tissue healing using MRI images and shoulder strength. Study protocol and medical expert oversight are being provided by John Sperling, M.D. and Joseph Iannotti, M.D.
Dr. Sperling commented, “The clinical trial to investigate the potential benefits of Conexa represents a significant commitment from Tornier to support science-based clinical research. Dr. Iannotti and I look forward to working with leading shoulder surgeons nationally and internationally on this important project.”
Tears of the rotator cuff, the group of tendons and muscles that maintains the stability and range of motion of the shoulder, are among the most common of orthopaedic injuries. Large rotator cuff tears are especially challenging with research published in the Journal of Bone and Joint Surgery and other publications reporting re-tear rates that range from 29% to 94% and that increase dramatically with complicating factors such as advanced age, diabetes, and tobacco use. Patients with non-healed rotator cuff tears can face diminished function or permanent disability.
Conexa™ is a porcine-derived tissue matrix that was developed by LifeCell™ Corporation, a KCI Company, and licensed to Tornier for distribution to its orthopaedic surgeon customers. LifeCell™ Corporation’s extensive animal studies and early clinical experience have demonstrated that the Conexa™ tissue matrix supports regeneration. It has been designed to perform in a manner similar to AlloDerm® Regenerative Tissue Matrix, LifeCell™ Corporation’s flagship human tissue matrix. In addition, Conexa™ is available sterile, ready to use, and in several sizes and thicknesses that are ideal for orthopaedic soft tissue repair applications. Since the first Conexa™ orthopaedic surgical procedures were performed in October 2008 by Dr. Iannotti and Dr. Sperling, approximately 1,500 patients have been successfully treated for the repair and/or reinforcement of tears of the rotator cuff, Achilles tendon, and other orthopaedic soft tissues.
Tornier develops and markets orthopaedic medical devices designed to restore function and return patients to an active and healthy lifestyle. The company’s innovative extremity and sports products include the Aequalis® line of shoulder arthroplasty prostheses; the Salto™ and Salto Talaris™ total ankle prostheses; a broad portfolio of foot and hand products including the NexFix™ system for reconstructive foot surgery and CoverLoc™ system for wrist fracture repair; the Piton™ shoulder anchor system and ArthroTunneler™ system for rotator cuff repair; and the Conexa™ tissue matrix for tendon and ligament repair. Tornier has established collaborations with innovative technology companies such as BioSurface Engineering Technologies, Bioretec, and Tepha Medical Devices in order to access novel non-metal technologies that may better address unmet soft and hard tissue repair needs of orthopaedic surgeons and their patients.
For more information regarding Tornier, visit www.tornier-us.com.