SAN JOSE, Calif., Feb. 12, 2016 /PRNewswire/ -- SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System® ("iFuse"), a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that National Government Services, Inc. (NGS), the Medicare Administrative Contractor (MAC) covering the states of Connecticut, Illinois, Maine, Massachusetts, Minnesota, New Hampshire, New York, Rhode Island, Vermont and Wisconsin has issued a positive local coverage determination (LCD) for MIS SI joint fusion that will become effective on April 1, 2016.
This positive coverage policy is based on the combination of more than two dozen SI-BONE clinical publications demonstrating the safety and effectiveness of iFuse that "consistently show improved pain scores with fewer complications than open fusion in patients with non-infectious, non-traumatic related SI pain"1 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). iFuse is the only MIS SI joint fusion device cleared by the FDA with an indication citing clinical studies that demonstrate 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. There are a total of 8 MACs responsible for over 50 million Medicare lives across the United States and NGS becomes the 7th MAC to provide coverage for MIS SI joint fusion, adding 9.5 million Medicare beneficiaries who will have access to iFuse. This will bring the total number of Medicare beneficiaries with access to iFuse to over 45 million in 49 states and the District of Columbia leaving First Coast Service Options of Florida the only MAC yet to provide coverage for iFuse.
"The decision by NGS is a positive step forward for Medicare beneficiaries in the NGS service area who will soon have access to the iFuse procedure and it is gratifying to know that Medicare recipients in all but one state will soon have coverage. Some doctors have said iFuse can be a life-changing procedure for properly diagnosed patients and our studies demonstrate that many people treated with iFuse have shown meaningful improvements in their quality of life and have been able to return to their normal activities of daily living following the procedure," 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.
SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2016 SI-BONE, Inc. All Rights Reserved. 9471.021216
1 NGS Administrators, LLC LCD L36406
SOURCE SI-BONE, Inc.