3D Systems
3D Systems has announced the Food and Drug Administration (FDA) has provided 510(k) clearance for TOTAL ANKLE Patient-Matched Guides to be used with Smith+Nephew’s SALTO TALARIS Total Ankle Prosthesis and CADENCE Total Ankle System. The products feature individualised pre-surgical planning and a patient-specific 3D printed instrument set that ensures accurate implant alignment and sizing for tailored total ankle replacement surgery.
3D Systems says the collaboration achieved these patient-matched solutions that enable surgeons to prepare the bony anatomy of the tibia and talus for placement of implants intended to restore proper function of the ankle joint. These patient-matched guides are engineered and manufactured using 3D Systems’ VSP surgical planning solutions.
3D Systems’ personalised solutions are designed to enable surgeons to capitalise on benefits such as performing the operation with less procedural steps, shorter operating room (OR) time, and less intraoperative x-ray radiation as compared to procedures using standard non-patient-specific instruments.
Ben Johnson, 3D Systems’ Vice President, Portfolio & Regulatory said: “With over 25 years of experience, our solutions have supported more than 175,000 patient-matched cases with the goal of improving surgical outcomes and the overall patient experience. Our VSP surgical planning workflow including the expertise of our biomedical engineers, our Selective Laser Sintering technology, and our DuraForm ProX PA materials is a differentiator in the market and was instrumental in the success of this program within a short timeframe.”
“We are excited to partner with 3D Systems and unveil our new TOTAL ANKLE Patient-Matched Guides for total ankle replacement — a breakthrough to help transform the way healthcare professionals approach surgical precision and improved patient outcomes,” added Mark McMahan, Vice President of Marketing, Global Orthopaedics at Smith+Nephew. “This advanced system is designed to offer unparalleled efficiency and accuracy, ultimately enhancing the overall experience for both surgeons and patients.”
3D Systems says it has manufactured more than 2 million medical device implants and supported over 100 FDA-cleared and CE-marked devices to date. The company's VSP surgical planning solutions include a service-based approach to personalised surgery, combining expertise in medical image processing, surgical planning, and 3D printing.
As 3D Systems’ technology has evolved over the last several years, the company is expanding its expertise beyond craniomaxillofacial applications to other parts of the human skeleton such as large joints. The company says it also sees tremendous opportunity for its solutions in trauma environments where both quality and response time are extremely important to patient outcomes.
3D Systems’ additive manufacturing solutions are helping to drive innovation in the global orthopedic devices market that is growing at a CAGR of 11.2% and is anticipated to reach 5.3 billion USD by 2023 according to the company.
“3D Systems is a recognised leader in supporting the medical device industry and surgeon community with early adoption in craniomaxillofacial procedures,” said Gautam Gupta, Ph.D., general manager and senior vice president, medical devices, 3D Systems. “Over the last several years, we have continued to leverage our VSP surgical planning workflows to expand into other personalised total joint orthopedic applications like shoulders and ankles. Through our collaboration with an industry leader such as Smith+Nephew, we leveraged our collective expertise in orthopedics to develop an end-to-end solution for total ankle replacements that is helping surgeons perform surgeries more efficiently. This is yet another great example of how our personalised orthopedics business continues to grow.”
