VGI Medical, LLC, an innovative company focused on design, development and manufacturing of spinal fixation devices, announces the success of the initial series of cadaver labs using its SiJoin® Triangular Trabecular Titanium (T3) Transfixing Device for sacroiliac (SI) joint fixation. The lab was performed by Dr. Steven Anagnost, MD in preparation for the product launch later this year.
Largo, FL (PRWEB)May 23, 2023
The patented, minimally invasive, SiJoin® T3 Transfixing Device is made from Ti-6AI-4V ELI titanium alloy using an additive manufacturing process, where the trabecular construction is engineered to mimic cancellous bone structure. The SiJoin® T3 Implant is engineered with a dual geometric shape designed to be implanted within the plane of the SI joint, simultaneously positioned within the ilium and sacrum, through the respective cortical wall, providing high surface area contact for fixation. The novel design of the SiJoin® T3 Device fixes the ilium and sacrum relative to one another, maintaining the anatomical spacing of the SI joint, providing mechanical support by transfixing the SI joint while biologic fusion occurs.
The SiJoin® T3 cadaver lab was a great success. The lab challenged the design of the implants, custom instruments and the surgical technique used in the SI joint fixation surgery. Overall, the lab was a great success in the validation of the SiJoin® T3 System design and provided critical data requested by the FDA for the 510(k) clearance in March 2023.
Dr. Steven Anagnost, a Board-Certified Orthopedic Spine Surgeon in Tulsa, OK, commented, “Overall very easy to access the SI without any distraction of the joint. Implants felt very solid on insertion with very good fixation. After insertion dissection showed no impingement of any neurovascular structures.”
Further, Dr. Anagnost commented “…very pleased at the implants ability to transfix the SI joint across both the sacrum and ilium.”
VGI Medical sincerely appreciates Dr. Anagnost’s assistance, expertise and support in the development of the SiJoin® T3 Transfixing Device.