Medical & Dental

3D Systems’ Vantage Ankle PSI awarded FDA clearance, distribution partnership signed with Exactech

3D printer manufacturer 3D Systems has received 510(k) clearance from the Food and Drug Administration (FDA) for its Vantage Ankle PSI patient-specific 3D printed surgical ankle instrument.

The Vantage Ankle PSI aids in total ankle replacement surgery carried out by medical device manufacturer Extactech’s Vantage Total Ankle System, through guiding resections in the tibia and talus. A collaboration between the two firms led to the conception of the Vantage Ankle PSI, which is claimed to be the only currently available method of facilitating direct patient-specific osteotomies (surgical operations whereby a bone is cut to shorten or lengthen it or to change its alignment) in the ankle.

“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 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 Vantage Ankle PSI is used exclusively with the Vantage Total Ankle System and provides patient-specific surgical planning and 3D printed instruments for tibia and talar resections. Image via Exactech.
The Vantage Ankle PSI is used exclusively with the Vantage Total Ankle System and provides patient-specific surgical planning and 3D printed instruments for tibia and talar resections. Image via Exactech.

3D Systems and the medical sector

In August, 3D Systems’ CEO Jeffrey Graves announced that the firm would be imminently restructured to focus on its ‘core business’ – its healthcare and industrial sectors. The news that the company has agreed to sell its Cimatron business and related subsidiaries to global technology-focused investment firm Battery Ventures for $65 million, further confirmed the importance of the medical 3D printing sector for 3D Systems.

3D Systems has an extended history in combining personalized medicine and 3D printing, having manufactured more than a million medical device implants. The firm has also contributed significantly to the advancement of surgical procedures through 3D printing and 3D scanning technologies. In October, the firm received 510(k) clearance from the FDA to 3D print maxillofacial surgical guides using its LaserForm Ti and DuraForm ProX PA materials. The materials will aid users in 3D printing innovative surgical guide designs as part of its Virtual Surgical Planning (VSP) service.

In September last year, 3D Systems received FDA approval for its VSP Orthopaedics platform, used for the virtual surgical planning of complex procedures. The platform is part of 3D Systems’ strategic approach to continue forging a strong position within the 3D healthcare sector.

Elsewhere, the firm has embarked upon accelerating breakthroughs in the biomedical industry through a partnership with bioprinting material developer CollPlant, and has helped ACS Custom upgrade its production of hearing aids through its Figure 4 offering.

Surgical marking guides are used to precisely guide drilling and cutting operations. Image via 3D Systems.
3D Systems is consolidating its business to focus on its healthcare and Image via 3D Systems.

The Vantage Ankle PSI

Born out of the partnership between 3D Systems and Exactech, the Vantage Ankle PSI aims to increase operating room efficiency with a patient-matched 3D printed instrument set. The product consists of pre-surgical planning and a 3D printed personalized instrument, which enables a surgeon to reduce the number of procedural steps needed to prepare a patient’s anatomy for surgery.

The Vantage Ankle PSI has a large footprint to enable the guide to be reliably seated on the bone anatomy and features a corrugated design on the cutting slots to facilitate surgical irrigation. Designed to improve soft-tissue preservation around the ankle joint, the instrument has soft tissue offsets engineered to preserve the fibrous layer of bone, called the periosteum, to aid in healing and recovery.

“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,” said Ellis.

ACS Custom's in-ear device built using 3D Systems' Figure 4 Standalone. Image via 3Dsystems.
ACS Custom’s in-ear device built using 3D Systems’ Figure 4 Standalone. Image via 3Dsystems.

3D Systems and Exactech’s partnership

The two firms have agreed a distribution partnership for 3D System’s Vantage Ankle PSI to be offered exclusively with Exactech’s Vantage Total Ankle System. At present, Exactech’s system is in the midst of a pilot launch with full market availability expected in late 2021.

“Our collaboration with 3D Systems represents a meaningful advancement that will accelerate the success of our Vantage Ankle prosthesis,” said Exactech 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.”

Exactech recently transitioned the manufacturing process of its Equinoxe Stemless Shoulder to laser based additive manufacturing. Prior to switching processes, Exactech was a customer of GE Additive acquired Arcam, which holds propriety EBM patents, and in 2010 was one of the first to get FDA approval for an implant product made using Arcam’s EDM technology.

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Featured image shows the Vantage Ankle PSI is used exclusively with the Vantage Total Ankle System and provides patient-specific surgical planning and 3D printed instruments for tibia and talar resections. Image via Exactech.