SurGenTec has received clearance from the US Food and Drug Administration (FDA) for its posterior sacroiliac joint fusion system, TiLink-P.
Said to be the first-of-its-kind, the new minimally invasive implant is intended for the treatment of patients with chronic sacroiliac (SI) joint pain.
It combines compression across the sacroiliac joint with a posterior implantation approach, allowing doctors to stabilise the painful area and offering patients a path to healing.
Unlike current methods, which involve multiple incisions and large bulky implants, the new minimally invasive technology only needs a single small incision and integrated implant.
Furthermore, TiLink-P facilitates the delivery of a substantial quantity of bone graft in and around the implant. It will help improve fusion and surgical outcomes.
Designed to require no additional hardware support for supporting the procedure, TiLink is approved as a stand-alone device that transfixes the ilium and sacrum.
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The company is presently collaborating with several navigation companies to use platforms that work in line with TiLink.
The 3D-printed titanium implant features Nanotex surface technology along with a trellis system for promoting osteointegration.
SurGenTec CEO Travis Greenhalgh said: “By combining the power of compression across the SI joint with the muscle-sparing posterior approach and the ability to reinforce with bone graft, TiLink offers surgeons a new and efficient way to enhance healing in patients.
“We anticipate that this groundbreaking technology will have a profound impact on patient outcomes and improve the overall quality of care.”
Earlier, the company received approval from the FDA for its Tilink lateral sacroiliac fusion system.