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Stratasys Direct Manufacturing
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3D Printed Surgical Tool Transforms ACL Reconstruction
DanaMed collaborated with Stratasys Direct Manufacturing to bring its breakthrough Pathfinder ACL device to market
VALENCIA, Calif.—A 3D printed surgical tool may be a medical breakthrough that high-performance athletes have been waiting for to repair damaged ACLs.
The Pathfinder™ ACL Guide is a biocompatible surgical device enabling surgeons to better reconstruct partially or fully torn anterior cruciate ligaments (ACL) and reduce the risk of re-tearing. DanaMed Inc.’s surgical device is manufactured using 3D printing by Stratasys Direct Manufacturing, a large provider of additive and conventional manufacturing in North America. Stratasys Direct Manufacturing builds the metal tool using Direct Metal Laser Sintering (DMLS™) technology.
“Pathfinder illustrates how 3D printing is uniquely capable of enabling breakthroughs in medical technology that otherwise would not be possible,” said John Self, project engineer at Stratasys Direct Manufacturing, in a press release. “And by offering DanaMed 97 percent cost savings over conventional manufacturing methods, 3D printing has demonstrated its business value in bringing complex, high-quality parts to market.”
With a broad range of additive and conventional manufacturing services, Stratasys Direct Manufacturing assists companies at all stages of product development to bring better products to the market faster. Stratasys Direct Manufacturing has more than 600 employees across seven manufacturing facilities in the United States.
Dr. Dana Piasecki, an orthopedic surgeon at OrthoCarolina Sports Medicine, in Charlotte, N.C., developed the Pathfinder System, comprising the Pathfinder ACL Guide and Guide Pins, after experimenting with surgical techniques that would improve graft positioning. The key, he discovered, is using a surgical tool specially shaped to match the anatomy of the knee. After refining the design using Fused Deposition Modeling™ (FDM®), Dr. Piasecki and DanaMed Inc. needed a manufacturing process that could efficiently produce the complex surgical instrument at an affordable price and provide the freedom necessary to make design changes on the fly. Stratasys Direct Manufacturing met these requirements by using DMLS.
The Pathfinders are printed with Inconel 718 material, which achieves the necessary biocompatibility, surface finish, oil resistance, and mechanical requirements. After extensive testing, the Pathfinder System was registered with the FDA as a Class 1 Medical Device. Pathfinders are now on the market and being used by orthopedic surgeons across the country.
To read more about DanaMed’s use of 3D printing, visit www.stratasysdirect.com/case-studies/dmls-surgical-guide/. To learn more about Stratasys Direct Manufacturing’s metal capabilities, go to www.stratasysdirect.com/solutions/direct-metal-laser-sintering/.
With a 95 percent success rate of anchoring grafts in their native ACL locations, DanaMed’s Pathfinder System is a potential game-changer for ACL repair surgeries. Anchoring grafts in this way may allow repaired ACLs to handle stress similar to what a natural ACL can handle. Other methods are more difficult to perform and can increase both the potential for surgical complications and risk of reinjuring the knee.
Like DanaMed, more and more companies are manufacturing metal parts via 3D printing. In fact, a recent survey sponsored by Stratasys Direct Manufacturing, “3D Printing’s Imminent Impact on Manufacturing,” found additive metal usage in the U.S. is expected to nearly double over the next three years. To meet the mounting market demand for metals, Stratasys Direct Manufacturing has nearly tripled its additive metals capacity over the past 18 months, the company said.
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