"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," 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. 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. 9470.061616
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/si-bone-inc-announces-medicare-administrative-contractor-first-coast-service-options-inc-fcso-establishes-coverage-for-mis-si-joint-fusion-300285653.html
SOURCE SI-BONE, Inc.