A Comprehensive Guide to Clinical Investigations: Content and Modifications in the EU – MDCG Guidance

A Comprehensive Guide to Clinical Investigations: Content and Modifications in the EU – MDCG Guidance Introduction: Clinical investigations play a...

Deadline for Submission of Medical Device Companies’ Annual Self-Inspection Report: March 31 Medical device companies play a crucial role in...

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FDA approves SurGenTec’s TiLink-L system for sacroiliac joint fusion

The sacroiliac joint is a crucial joint in the human body that connects the sacrum to the ilium. This joint is responsible for transferring weight and forces from the upper body to the lower body. However, when this joint becomes damaged or degenerated, it can cause severe pain and discomfort in the lower back, hips, and legs. In such cases, sacroiliac joint fusion surgery may be necessary to alleviate the pain and restore mobility.

Recently, the US Food and Drug Administration (FDA) approved SurGenTec’s TiLink-L system for sacroiliac joint fusion. This innovative system is designed to provide a minimally invasive approach to sacroiliac joint fusion surgery, which can reduce patient discomfort and recovery time.

The TiLink-L system consists of a titanium implant that is inserted into the sacroiliac joint to fuse the joint together. The implant is designed to be inserted through a small incision, which reduces the amount of tissue damage and scarring that occurs during surgery. Additionally, the implant is coated with a proprietary surface treatment that promotes bone growth and fusion.

One of the key benefits of the TiLink-L system is its ability to provide immediate stability to the sacroiliac joint. Unlike traditional sacroiliac joint fusion surgery, which can take several months for the bones to fuse together, the TiLink-L system provides immediate stability to the joint. This can help patients experience relief from their pain and discomfort much sooner than with traditional surgery.

Another benefit of the TiLink-L system is its compatibility with a variety of surgical techniques. The system can be used with both open and minimally invasive surgical approaches, which allows surgeons to choose the best technique for each individual patient.

The FDA approval of the TiLink-L system is a significant milestone for SurGenTec and for patients suffering from sacroiliac joint pain. The system provides a safe, effective, and minimally invasive approach to sacroiliac joint fusion surgery, which can help patients experience relief from their pain and discomfort much sooner than with traditional surgery. As more surgeons adopt this innovative system, it is likely that we will see a significant increase in the number of successful sacroiliac joint fusion surgeries performed each year.

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