August 2, 2011
Simpliciti System Also Recently Launched in Europe at Prestigious Annecy Shoulder Course
AMSTERDAM--(BUSINESS WIRE)-- Tornier N.V. (NASDAQ:TRNX), a leading global medical device company focused on serving extremities specialists who treat orthopaedic conditions of the shoulder, elbow, wrist, hand, ankle and foot, today announced two milestone events for the Company's new SimplicitiTM stemless shoulder joint replacement system. Tornier announced that the first patient has been enrolled and treated successfully with the Simpliciti prosthesis as part of an FDA Investigational Device Exemption (IDE) clinical study. The Company also announced the commercial release of the Simpliciti system outside of the United States at the Annecy Live Surgery International Shoulder Advanced Course, held in Annecy, France, June 2-5, 2011.
The first patient in the Simpliciti IDE study was treated on July 29, 2011, at Saint Agnes Hospital in Fresno, Calif., by Thomas W. Thomas, MD, an orthopaedic surgeon specializing in shoulder surgery. Tornier is the first orthopaedic company to participate in a multi-center, prospective FDA-approved clinical trial for a stemless shoulder prosthesis. The trial is designed to enroll 157 patients who will be followed for two years.
Thomas commented, "Simpliciti is an exciting alternative for patients needing a shoulder replacement that preserves humeral bone, simplifies the surgical approach and renders potential future interventions much less complicated. I was impressed with the straightforward nature of the Simpliciti operation, the intuitive instrumentation, and, in particular, the humeral metaphyseal fixation."
Prior to the commercial launch outside of the U.S., Tornier received European CE Mark clearance on February 28, 2011. The first Simpliciti implant procedure was completed on April 7, 2011, by Mr. Gavin Tait, consultant surgeon and clinical director at Crosshouse Hospital, Ayrshire & Arran NHS in Glasgow, Scotland.
Tornier's Simpliciti stemless shoulder system bridges the gap between humeral bone resurfacing and traditional shoulder arthroplasty systems. The Simpliciti system has been designed to provide the bone-preserving benefits of stemless resurfacing implants while also providing total joint system clinical benefits and necessary surgical access. The Simpliciti system, featuring the preservation of the humeral canal and cementless "press fit" fixation, has been designed to facilitate revision surgery for younger patients who may require a further shoulder joint replacement procedure.
Tornier is a global medical device company focused on serving extremities specialists who treat orthopaedic conditions of the shoulder, elbow, wrist, hand, ankle and foot. The Company's broad offering of over 80 product lines includes joint replacement, trauma, sports medicine, and biologic products to treat the extremities, as well as joint replacement products for the hip and knee in certain international markets. Since its founding nearly 70 years ago, Tornier's "Specialists Serving Specialists" philosophy has fostered a tradition of innovation, intense focus on surgeon education, and commitment to advancement of orthopaedic technology stemming from its close collaboration with orthopaedic surgeons and thought leaders throughout the world. For more information regarding Tornier, visit www.tornier.com.
Kirsten Harrison, +1-952-426-7600
Source: Tornier N.V.
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