VYRSA Technologies has announced US Food and Drug Administration (FDA) clearance of its VYRSA V1 sacroiliac (SI) fusion system.
According to a press release, after an extensive two-and-a-half-year biomechanical testing protocol, the company submitted a comprehensive data set to the FDA showing overwhelming evidence of biomechanical stability in the sacroiliac joint after implantation of the VYRSA V1 system.
According to data from the biomechanical testing reports for SI joint fixation, the report noted that: “We found no significant differences between the Test, VYRSA V1, and Control implant groups with respect to any of the outcome measures investigated.” It concluded: “The lack of a statistically significant difference between the two techniques evaluated in this study is consistent with previous studies comparing the lateral and posterior approaches to SI joint fusion.”
Terry Harvey, president of VYRSA Technologies, said: “The entry of the VYRSA V1 implant into the US market represents a huge step for VYRSA in continuing to provide innovative, physician-friendly solutions for the treatment of sacroiliac joint dysfunction. The FDA 510(k) clearance is a very exciting step forward for patients who suffer from pain due to sacroiliac joint disruptions and degenerative sacroiliitis.”
The VYRSA V1 titanium implant is a fusion device consisting of a 3D-printed titanium body with a roughened surface that encourages bone growth onto the surfaces of the device. The V1 implant surfaces are designed and engineered with pores that average 500 microns in diameter, the optimal environment for bone to grow and fully incorporate the implant within the sacroiliac joint, say VYRSA Technologies.
VYRSA V1 has multiple openings to allow a large volume of autogenous bone graft to be easily packed into the implant to facilitate fusion and the device features two sharpened anchor plates housed within the 3D-printed body until they are deployed into the ilium and sacrum to provide fixation, adds they company.