May 19, 2016
LUGANO, Switzerland–(BUSINESS WIRE)–Medacta today announced new data that speak to the ability of its products to positively impact the orthopedic surgery experience. The company also announced new milestones in the number of implants used and procedures performed. The announcements follow the 8th M.O.R.E. International Symposium, a clinical educational meeting encompassing more than 1,000 surgeons from around the world, held last month near the company’s global headquarters in Lugano, Switzerland.
“The high adoption rate of Medacta’s surgical products and promising clinical data reviewed at the M.O.R.E. Symposium are testaments to the work we’re doing to improve the orthopedic experience both for patients and surgeons,” said Francesco Siccardi, Executive Vice President of Medacta International. “The positive feedback we’ve received for AMIStem and continued enthusiasm for GMK Sphere, MyKnee and MySpine suggest there is a clear need for products that combine meticulous design, responsible innovation and a commitment to health-economic sustainability.”
More than 200,000 AMIS® procedures completed and 100,000 AMIStem implants used, as new data demonstrate ODEP quality
During the 8th International M.O.R.E. Symposium, Richard Field, MD, Professor of Orthopaedic Surgery at St George’s University of London, reported on the clinical results of Medacta’s AMIStem hip implant from a multi-center study designed to comply with the UK Orthopaedic Data Evaluation Panel (ODEP) recommendation – a verified assessment of an implant’s performance and an important factor surgeons consider in selecting appropriate implants for joint replacement procedures.
The study of 421 patients found the five-year survival rate of AMIStem implants to be 97.75 percent and scored the implant a 5A rating from ODEP, which according to ODEP, puts AMIStem on track to have outcomes in-line with a 10A rating, for which a 10-year follow-up is required. Based on these results, Medacta’s AMIStem provides a safe and reliable solution for cementless total hip arthroplasty and good medium-term results for implant survival and clinical outcomes evaluations.
The AMIStem system is often utilized with Medacta’s Anterior Minimally Invasive Surgery (AMIS) approach to total hip replacement. To date, AMIStem has been used more than 100,000 times, while the AMIS technique itself has been performed over 200,000 times. Supported by Medacta’s M.O.R.E. Educational Platform, more than 85 percent of the company’s hip replacement surgeries are now performed through AMIS.
More than 40,000 MyKnee® procedures performed to date, providing superior function and accuracy
Also at the M.O.R.E. Symposium, Dr. Stefan Buchleitner, from Krankenhaus Barmherzige Schwestern Wien in Austria, compared the clinical and radiologic outcomes of Medacta’s CT-based MyKnee instrumentation, a system of patient-matched cutting blocks that personalizes total knee replacement (TKR) procedures through preoperative 3D planning based on each patient’s unique anatomy. More than 40,000 MyKnee procedures have been performed to date with many peer-reviewed publications evaluating the quality and potential benefit of this innovation. This represents roughly 60 percent of all Medacta knee implantations.
In this specific study of 222 consecutive total knee arthroplasties, patients from the MyKnee study group saw a significant improvement in Knee Society Function score and VAS pain score compared to patients in the conventional instrument group. Dr. Buchleitner also reported greater alignment accuracy compared to conventional instruments, demonstrating important benefits that Medacta’s CT-based MyKnee Patient Matched Technology can provide.
Over 15,000 GMK® Sphere knees implanted since 2011, comparing favorably against other ODEP-rated implant designs
At the Symposium, Dr. Field also presented clinical results of Medacta’s GMK Sphere total knee replacement from a multi-center study designed to comply with ODEP recommendation. The study followed 280 patients receiving a GMK Sphere knee replacement from eight different surgeons, tracking preoperative and postoperative outcomes via multiple measurement systems, including EQ 5D Scores, Knee Society Score, and the Oxford Knee Score. Dr. Field concluded that the overall GMK Sphere revision rate was consistent with ODEP criteria and that the improvement in patient outcome scores with GMK Sphere at one and three years compared favorably against other ODEP-rated implant designs.
The GMK Sphere is an innovative total knee implant designed to deliver maximum functional stability with the goal of increasing patient satisfaction and decreasing postoperative knee pain. More than 15,000 GMK Sphere knees have been implanted since 2011.
MySpine pedicle screw placement yields promising results
Pedicle screws are the gold standard for the correction of spine degenerative disease, deformity and trauma; however, the procedure is demanding and complications can result from inaccurate screw placement. A study authored by Prof. Claudio Lamartina, Head of Operational Spine Unit at the Istituto Ortopedico Galeazzi IRCCS in Milan, Italy, and presented at the symposium examined Medacta’s MySpine patient-matched pedicle screw placement guide in three cadaveric spine specimens operated on by three surgeons. Of 46 inserted screws eligible for assessment, 91.3 percent were fully inside the pedicle. The findings indicate pedicle screw placement with Medacta’s MySpine technology is highly accurate and should be investigated in larger in vivo studies.
Medacta® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS®system and total knee replacement with MyKnee® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a holistic approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.
For Medacta International, Inc.
Jill Bongiorni, 516-729-2250