FDA Clears 3D Systems Patient-Specific 3D Printed Surgical Guides for Ankles

Leading additive manufacturing solutions partner 3D Systems announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s 3D printed Vantage Ankle PSI (patient-specific instrumentation) surgical cutting guides. Manufactured by 3D Systems, the product will be distributed only in the United States by medical device company Exactech and includes a pre-surgical planning and patient-specific 3D printed instrument set that guides resections in the tibia and talus for total ankle replacement surgery using Exactech’s Vantage Total Ankle System.

The Vantage Ankle PSI 3D-printed cutting guides are designed for patients’ unique anatomies, and allow surgeons to pre-plan tibia and talar resections to align and cut in one step. Delivered within just two weeks, the instruments are designed for a reproducible fit as part of Exactech’s Active Intelligence initiative and are used exclusively with the Vantage Total Ankle System, an easy-to-use solution designed to conserve bone that allows for both stability and mobility in total ankle replacement. The product increases operating room (OR) efficiency, reliability, and improves soft-tissue preservation around the joint.

The Vantage Ankle PSI provides patient-specific surgical planning and 3D printed instruments for tibia and talar resections. Image courtesy of Exactech

Since 2013, the use of 3D printing in surgery has increased exponentially. Based on 3D medical imaging of the actual patient anatomy, the technology has been helping produce the tools necessary to perform better operations, and in the case of 3D printed patient-specific guides, it means fewer procedural steps and OR time. PSI surgical guides have proven extremely helpful in surgical outcomes and patient health, mainly by increasing the predictability, reliability, and accuracy of the surgery, as well as providing better chances of a quick recovery.

Customized orthopedic instruments, in particular, are an enabling technology that helps surgeons prepare the skeletal anatomy to receive an implant. The new Vantage Ankle PSI product is designed to increase surgical efficiency by allowing the surgeon to reduce the number of steps required to prepare the anatomy with a patient-matched 3D printed instrument set. Moreover, 3D Systems claimed it is the only solution to facilitate direct patient-specific osteotomies in the ankle.

The Vantage Ankle PSI 3D printed tibia and talar cutting guides. Image courtesy of Exactech

The jointly developed end-to-end solution collaboration resulted in a product with unique features. According to 3D Systems and Exactech, these include a large footprint that helps to reliably seat the guide on the bone anatomy offering a more stable fit; improved visibility to alignment, and a corrugated design on the cutting slots that aid surgical irrigation. This is complemented by soft tissue offsets which are designed to preserve the periosteum, the outer fibrous layer of the bone which aids in its healing and recovery.

“3D Systems was founded on a spirit of innovation, and we are constantly looking for opportunities to expand the applications that can be addressed with our VSP® surgical planning solutions to benefit the medical community,” said Menno Ellis, Executive Vice President (EVP) of healthcare solutions at 3D Systems. “Through our collaboration with Exactech, we drew upon our collective expertise in orthopedics to develop an end-to-end solution for total ankle replacements that is unique to the market. The combination of pre-surgical planning and 3D-printed, patient-specific instruments allows the surgeon to visualize the patient anatomy and surgical approach in three dimensions, and then perform the surgery more efficiently with improved surgical outcomes.”

The innovation is the latest in a series of pioneering personalized medical solutions by 3D Systems. The Rock Hill, South Carolina-based company has already engineered surgical planning products as part of its service-based approach to personalized surgery. By combining expertise in medical image processing, surgical planning, and 3D printing, and working with surgeons to plan and guide more than 140,000 patient-specific procedures, the company has been bridging the gap between 3D printing and medicine. 3D Systems also said it has manufactured more than one million medical device implants and supports over 85 CE-marked (required for many products in the European Union) and FDA-cleared products.

Vantage Total Ankle System. Image courtesy of Exactech

“Our collaboration with 3D Systems represents a meaningful advancement that will accelerate the success of our Vantage Ankle prosthesis,” said Exactech’s CEO Darin Johnson. “Their expertise in surgical planning, as well as medical device design, regulatory, and manufacturing was invaluable in developing this patient-specific solution. The Exactech team is eager to bring this solution to market to simplify ankle arthroplasty’s surgical technique and enhance the patient and surgeon experience.”

The Gainesville, Florida developer and producer of innovative implants, instrumentation, and computer-assisted technologies for joint replacement surgery, has been addressing clinical challenges since 1985. This latest creation adds to a growing portfolio of customized solutions for treating injuries or joint diseases, that already includes 3D printed stemless shoulder implants, the FDA approved 3D printed acetabular cups and lumbar interbody fusion cages.

3D Systems and Exactech’s Vantage Ankle PSI product will be offered exclusively with Exactech’s Vantage Total Ankle System. The Vantage Ankle PSI is currently in a pilot launch with full market availability expected in late 2021, but the companies are encouraging interested surgeons to contact their Exactech sales representative directly, visit Exactech’s website or join a live webinar on December 1, 2020, to learn more about the product.