KING OF PRUSSIA, Pa., Dec. 2, 2022 /PRNewswire/ — VYRSA Applied sciences, a specialty medical machine agency, introduced immediately the FDA clearance of the VYRSA V1™ SI Fusion System. After an intensive two 1/2-year biomechanical testing protocol, VYRSA Applied sciences submitted a complete information set to the FDA exhibiting overwhelming proof of biomechanical stability within the sacroiliac joint after implantation of the VYRSA V1™ SI Fusion System.
In line with information from the biomechanical testing stories for SI joint fixation, “We discovered no important variations between the Take a look at, VYRSA V1™, and Management implant teams with respect to any of the end result measures investigated.” The report concluded, “The shortage of a statistically important distinction between the 2 strategies evaluated on this research is in keeping with earlier research evaluating the lateral and posterior approaches to SIJ fusion.”
Terry Harvey, president of VYRSA Applied sciences, feedback, “The entry of the VYRSA V1™ implant into the U.S. market represents an enormous step for VYRSA in persevering with to supply revolutionary, physician-friendly options for the therapy of sacroiliac joint dysfunction. The FDA 510k clearance is a really thrilling step ahead for sufferers who are suffering from ache on account of sacroiliac joint disruptions and degenerative sacroiliitis.”
The VYRSA V1™ titanium implant is a fusion machine consisting of a 3D-printed titanium physique with a roughened floor that encourages bone development onto the surfaces of the machine. The V1 implant surfaces are designed and engineered with pores that common 500 microns in diameter, the optimum surroundings for bone to develop and totally incorporate the implant inside the sacroiliac joint. VYRSA V1™ has a number of openings to permit a big quantity of autogenous bone graft to be simply packed into the implant to facilitate fusion. The machine options two sharpened anchor plates housed inside the 3D-printed physique till they’re deployed into the ilium and sacrum to supply fixation.
About VYRSA Applied sciences
VYRSA Applied sciences, Inc., is a specialty medical machine agency primarily based in King of Prussia, PA. VYRSA Applied sciences is a frontrunner in know-how for the surgical therapy of musculoskeletal issues of the sacropelvic anatomy. With an revolutionary portfolio of MIS allograft implants and revolutionary transfixing medical gadgets, VYRSA Applied sciences is uniquely positioned as an trade chief in sacroiliac fusion.
Be taught extra at www.vyrsatech.com.
Media Contact: Terry Harvey firstname.lastname@example.org
Investor Contact: Dan Pontecorvo email@example.com