Medacta Receives CE Marking for its Long Diaphysis and Stemless Metaphysis Implants for Shoulder Joint Replacement
CASTEL SAN PIETRO, 03 June 2020 - Medacta today announced it has obtained CE marking for its Long Humeral Diaphysis and Stemless Humeral Metaphysis implants for shoulder joint replacement.
Long Humeral Diaphysis and Stemless Metaphysis: More Options in Shoulder Arthroplasty
The Long Humeral Diaphysis, which has recently obtained clearance from the Food and Drug Administrations (FDA) for use in the U.S., can help surgeons facing complex cases of shoulder replacement, particularly when there is a need for extended distal fixation.
The Stemless Humeral Metaphysis is intended for use in anatomic configuration and enables a minimally invasive approach at the humeral level, preserving the humeral canal. The Stemless Humeral Metaphysis features Medacta's 3D Metal surface, an advanced, 3D-printed structure designed to improve the metal-bone mechanical bond.
Medacta collaborated with several expert surgeons to develop its new options for shoulder replacement. Prof. Dr. Bernhard Jost, Chief of Department / Head Shoulder-Elbow, Department of Orthopaedics and Traumatology, Kantonsspital St. Gallen, Switzerland, is one of the designers and has worked closely with Medacta's engineers on the successful development of both the Long Humeral Diaphysis and Stemless Humeral Metaphysis.
'With these two additional components, the Medacta Shoulder System becomes more complete, allowing surgeons to widen their clinical use of the system by addressing more patient morphologies and pathologies,' said Prof. Jost.
Francesco Siccardi, CEO of Medacta has stated: 'Since its founding in 1999, Medacta has focused on developing new and improved products, technologies and methodologies for the orthopaedics market. In the intervening 20 years, Medacta has become a pioneer in developing new offerings based on minimally invasive surgical techniques that help support faster recovery and an improved patient experience. With the new Stemless Humeral Metaphysis, Medacta is now able to offer a minimally invasive solution for shoulder arthroplasty and continue our commitment to improve the care and well-being of orthopaedic patients around the world'.
Responsible Introduction to the Market for a Complete and Innovative Shoulder Portfolio
The Long Humeral Diaphysis and Stemless Metaphysis will be introduced in select hospitals following the guidelines of Medacta's M.O.R.E. Excellence Clinical Program. With the goal of responsibly introducing innovative products to the market, Medacta releases new products on a restricted basis to conduct voluntary clinical programs in order to further document and confirm their efficacy.
Both implants are part of the Medacta Shoulder System, an innovative shoulder replacement system that features a broad range of options and allows surgeons to choose the best implant for their patients. As a modular system, the Medacta Shoulder System offers the flexibility to move, if necessary, from a hemi-arthroplasty to a total or reverse arthroplasty. Since the implants are compatible and work in conjunction with each other, this innovative system is complete and convertible. With these new implants, the Medacta Shoulder System becomes even more robust with a comprehensive range of stemless, short, standard and long stems.
To learn more about Medacta's shoulder portfolio, please visit shoulder.medacta.com.
Medacta International SA
Senior Director Global Marketing
Phone: +41 91 696 60 60
Medacta is an international company specialized in the design and production of innovative orthopaedic products and the development of accompanying surgical techniques for joint replacement, spine surgery, and sports medicine. Established in 1999 in Switzerland, Medacta's products and surgical techniques are characterized by innovation. Medacta is a pioneer in developing new offerings on the basis of minimally invasive surgical techniques, in particular its Anterior Minimally Invasive Surgery ('AMIS') technique for hip replacements. Medacta has leveraged its orthopaedic expertise and comprehensive understanding of the human body to develop the sophisticated 'MySolutions' technology, which offers surgeons highly personalized pre-operative planning and implant placement methodologies by creating advanced personalized kinematic models and 3D planning tools for use in hip, knee, shoulder and spine procedures.