3D Systems receives FDA approval for Vantage Ankle PSI

3D Systems, one of the oldest additive manufacturing companies, announced that the American Food and Drug Administration (FDA) approved its Vantage Ankle PSI for medical use. The product is a collection of patient-specific total ankle surgical planning and 3D printed instruments that guide resections in the tibia and talus for total ankle replacement surgery. 3D Systems paired its product with Exactech‘s Vantage Total Ankle System to increase operating room efficiency and reliability. The product will also help preserve soft tissues around the affected joint. The system is in a pilot launch, with full market availability projected to occur in late 2021.

Exactech is partnered with 3D Systems under a distribution agreement for its and 3D’s Vantage products. One system will be sold with the other.

3D Systems is recognized as a pioneer in the personalized medicine space. The Company has manufactured more than 1 million medical device implants and supports 85+ CE-marked and FDA-cleared products. 3D Systems’ VSP surgical planning solutions include a service-based approach to personalized surgery, combining expertise in medical image processing, surgical planning, and 3D printing. The company has a long history in surgical planning with more than 10 years of expertise in craniomaxillofacial applications. To date, 3D Systems has worked with surgeons to plan and guide more than 140,000 patient-specific procedures.

Patient-specific orthopedic instruments are an enabling technology that helps surgeons prepare the skeletal anatomy to receive an implant. The Vantage Ankle PSI product, the only solution to facilitate direct patient-specific osteotomies in the ankle, 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. Features unique to the product include a large footprint that helps to reliably seat the guide on the bone anatomy, 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, EVP, healthcare solutions, 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.”