Si-Bone said this week it won updated 510(k) clearance indications for its iFuse implant system and reimbursement coverage for its minimally invasive surgery sacroiliac joint fusion systems through Medicare Administrative Contractor FCSO.
Si-Bone said the FDA modified the indication statement for its iFuse sacroiliac joint fusion system to include that clinical studies have demonstrated that treatment with the system can improve pain, patient function and quality of life.
“SI-BONE’s strong clinical evidence demonstrating consistently positive results across multiple clinical trials makes it much easier for our regulatory team and the Agency to process our regulatory applications, such as this premarket notification to update the indication statement,” quality and regulatory affairs veep Roxanne Dubois said in a press release.
The revised indication statement is based on safety and effectiveness data from retrospective studies and 3 prospective clinical trials, the San Jose, Calif.-based company said.
“This is a significant milestone in the evolution of the treatment of SI joint dysfunction and clearly sets iFuse apart from any other surgical treatment option. No other surgical treatment option for SI joint dysfunction is supported by prospective data and now with over 21,000 procedures performed worldwide, iFuse is clearly the surgical treatment of choice for SI joint dysfunction due to SI joint disruption or degenerative sacroiliitis,” CEO Jeffrey Dunn said in a prepared release.
Today, Si-Bone said that the FCSO changed the coverage criteria for the company’s MIS SI joint fusion devices, now considering coverage on a case by case basis for the treatment of chronic back pain for certain patients.
The reimbursement win is the 8th and final MAC that now provides access to coverage for its MIS SI joint fusion devices, according to Si-Bone.
“With this positive coverage decision by First Coast Service Options, iFuse is now covered by all Medicare Administrative Contractors. Hence, Medicare beneficiaries across the entire country have access to this life changing procedure. This is a major milestone and should help the many people who are affected by debilitating SI joint disease,” health outcomes & reimbursement veep Michael Mydra said in prepared remarks.
