SAN JOSE, Calif., December 21, 2015 — SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System®, a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that CGS Administrators, LLC (CGS) the Medicare Administrative Contractor (MAC) covering the states of Kentucky and Ohio has issued a positive local coverage determination (LCD) for MIS SI joint fusion that will become effective on February 1st, 2016. This positive coverage policy is based on the combination of a number of clinical publications demonstrating the safety and effectiveness of the iFuse Implant System that “consistently show improved pain scores with fewer complications than open fusion in patients with non-infectious, non-traumatic related SI pain” combined with positive medical professional society coverage recommendations from the North American Spine Society (NASS) and the International Society for the Advancement of Spine Surgery (ISASS). The iFuse Implant System is the only MIS SI joint fusion device cleared by the FDA with an indication citing clinical studies that demonstrated improved pain, patient function and quality of life out to 12 months post-implantation and, to our knowledge, the only commercially available MIS SI joint fusion device in the United States with published clinical evidence demonstrating safety and effectiveness for SI joint fusion. CGS becomes the 6th MAC to provide coverage for MIS SI joint fusion adding 2.8 million Medicare beneficiaries who now have access to MIS SI joint fusion bringing the total number of Medicare covered lives to almost 30 million.
“This is a welcomed decision by CGS Administrators and not only continues to validate the safety and effectiveness of the iFuse Implant System, but also creates access for numerous Medicare beneficiaries in need of this treatment,” said Michael Mydra, Vice President, Health Outcomes & Reimbursement, SI-BONE.
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading sacroiliac joint medical device company dedicated to the development of tools and products for patients with low back issues related to certain SI joint disorders. The company develops, manufactures and markets minimally invasive products for the SI joint. SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November 2010.
The iFuse Implant System is a minimally invasive surgical option that uses titanium implants coated with a porous, titanium plasma spray (TPS) that acts as an interference surface, designed to help decrease implant motion, and allow for biological fixation to support long term fusion. The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life at 12 months post-implantation. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks.