JointMedica, a global leader in orthopedic innovation, announces the commencement of an Investigational Device Exemption (IDE) study for its Polymotion® Hip Resurfacing (PHR®) device. The IDE study aims to evaluate the safety and clinical effectiveness of the Polymotion® Hip Resurfacing System to address the challenges faced by younger, more active patients.
Polymotion® Hip Resurfacing conserves bone by removing less of the femoral head than traditional hip replacement, reshaping it to accommodate a metal cap that mirrors the natural anatomy. A cup made of Vitamin E polyethylene with a titanium coating is implanted into the patient’s acetabulum. A comprehensive range of sizes is offered to match most patients. Both components are designed to be permanently implanted to achieve reconstructive and functional hip joint replacement. The PHR® System is intended to offer benefits over total hip arthroplasties, such as bone conservation and restoration of more natural biomechanics, without a metal-on-metal articulating surface.
The IDE study has officially launched at seven esteemed clinical sites:
Mr. Ronan Treacy and Dr. Will Peckett– King Edward VII (Bermuda)
Dr. Thomas Gross and Dr. Coleman Fowble– Midlands Orthopaedics & Neurosurgery (Columbia, SC)
Dr. Stephen Raterman– Florida Medical Clinic Orlando Health (Tampa, FL)
Dr. William Macaulay, Dr. Scott Marwin, and Dr. Matthew Hepinstall- NYU Langone (New York, NY)
Dr. Craig Della Valle- Rush University Medical Center (Chicago, IL)
Dr. Michael Mont, Dr. Ronald Delanois, and Dr. James Nace- Sinai Hospital (Baltimore, MD)
Dr. Anthony Carter- Hampton Roads Orthopaedics (Newport News, VA)
Mr. Treacy stated, "It’s exciting to be part of such a valuable study with esteemed colleagues to allow us to evaluate this technology with the goal of making it available to a wider public over the next few years. I would like to thank the King Edward VII Hospital in Bermuda for their hard work and support in this venture.”
“Previously, some patients have shied away from hip resurfacing, fearful of metal wear debris. The Polymotion® implant has a metal-on-plastic bearing rather than a metal-on-metal bearing,” Dr. Gross said. “Women have often been denied a metal-on-metal hip resurfacing operation because they may be more sensitive to metal wear debris. We are encouraged that more patients may now have an alternative to traditional hip replacement surgery.”
“I am excited to be able to study the Polymotion® Hip Resurfacing implant which eliminates a metal-on-metal bearing and has a wider size range to include women,” said Dr. Raterman.
“These clinical investigations are crucial to evaluating the safety and effectiveness of the Polymotion® system. We are honored to collaborate with such renowned surgeons who bring unparalleled expertise to this study,” said Dr. Sharat Kusuma, President at JointMedica.
JointMedica is expanding the clinical study sites in the coming months to gather comprehensive data on the long-term safety and effectiveness of the Polymotion® Hip Resurfacing system.
For More Information
To learn more about the Polymotion® Hip Resurfacing System and the IDE study, please contact: cs@jointmedica.com
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About JointMedica
JointMedica will be the leading developer of transformative hip arthroplasty solutions, with dedication to the highest quality manufacturing and industry-leading clinical performance.
Leveraging over two decades of dedicated research and development, JointMedica focuses primarily on hip arthroplasty, prominently featuring the Polymotion® Hip Resurfacing System. With distinctive innovation, strategic partnerships with industry leading surgeon, and continuous expansion in manufacturing capabilities, JointMedica looks forward to providing solutions to patients and healthcare providers
Visit: www.jointmedica.com
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Mr. Treacy stated, "It’s exciting to be part of such a valuable study with esteemed colleagues to allow us to evaluate this technology with the goal of making it available to a wider public over the next few years."
