Published: August 02, 2011
Tornier Announces First Implant in U.S. Clinical Study for the SimplicitiTM Stemless Shoulder Joint Replacement System
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.
About Tornier
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.

Tornier N.V.
Kirsten Harrison, +1-952-426-7600
Copyright © 2012, Business Wire, Inc., All rights reserved.
Copyright © 2012, NewsBlaze,
Daily News