October 11, 2018
CASTEL SAN PIETRO, Switzerland–(BUSINESS WIRE)–Medacta® International, the privately owned, global leader in innovative joint replacement and spinal technologies, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for the Mpact 3D Metal™ Implants and Augments 3D Metal as enhancements to its Mpact® System for primary to complex hip revision procedures. The first stateside surgery utilizing the implant and augments was performed this summer by Tyler Goldberg, M.D., of Austin-based Texas Orthopedics, Sports & Rehabilitation Associates.
The new implants, Mpact 3D Metal Acetabular Two-Hole and Multi-Hole Shells, are hemispherical porous shells with multiple highly cross-linked polyethylene liner options. The implants’ ultra-porous material makes them ideal for more demanding primary patient cases or to address difficult revisions with compromised bone. They are complemented by the porous 3D Metal Augments, designed to act as a defect-filling implant in cases of severe bone loss to help increase implant stability. The augments come in a variety of shapes and sizes, giving surgeons intraoperative flexibility to address a wide variety of acetabular defects. Together, these additions strengthen Medacta’s Mpact System and provide surgeons with more options when addressing complex primary hip replacements, as well as revisions.
Dr. Goldberg’s primary case utilized the Mpact Two-Hole Shell. “I was impressed with how firm the Mpact 3D Metal Implant was upon initial impaction. The shell has exceptional grip, making primary fixation easy and solid,” Dr. Goldberg said of his experience. “Knowing the shell is of high porosity and solid nature gave me great confidence for durable bone ingrowth, and my patient is recovering very well.”
The Mpact 3D Metal Implants feature Medacta’s proprietary 3D Metal technology, constructed via additive manufacturing performed by a 3D printer. The result is enhanced initial stability due to a high coefficient of friction at the bone interface and favorable environment for bone without the need for an additional coating. The 3D Metal Shells and Augments have pore sizes of 600-800 micrometers and continuously interconnected open pores with a high-porosity level of 75 percent.
“Medacta continues to expand upon its product portfolios as we seek to help our surgeon partners address more patient cases than ever before, whether it’s a complex primary case or a difficult revision,” said Francesco Siccardi, Executive Vice President of Medacta International. “With the new Mpact 3D Shells and 3D Metal Augments, our Mpact System offers even greater versatility and continues to instill confidence, thanks to both the high-grade materials used and the built-in surgeon education and support system for which Medacta is well known.”
The Mpact 3D Metal Implants and Augments are compatible with several surgical techniques, including Medacta’s Anterior Minimally Invasive Surgery (AMIS®) approach to hip replacement. The muscle-sparing AMIS approach is supported by the Medacta Orthopaedic Research and Education (M.O.R.E.) Institute, which provides surgeons with educational resources, training and mentorship as well as dedicated tools and instruments as they transition and practice the technique.
For more information, visit Medacta’s Mpact System webpage.
About Medacta International
Medacta® International is a world leading company, developer and supplier, specializing in joint replacement, spine surgery, and sports medicine solutions. Medacta’s revolutionary approach and responsible innovation, focusing on Minimally Invasive Solutions and Personalized Medicine, have resulted in standard of care breakthroughs in hip replacement with the AMIS® system and total knee replacement with MyKnee® patient matched technology. Medacta has grown dramatically by taking a different 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, operates in over 30 countries around the globe, and employs more than 930 people. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter and LinkedIn.
For Medacta International
Jill Bongiorni, 516-729-2250