Monday, January 05, 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 the Medicare Administrative Contractor (MAC) Noridian Healthcare Solutions, LLC began covering MIS SI joint fusion, including use of the iFuse Implant System, effective January 1, 2015. The change by Nordian enables more than 9 million Medicare beneficiaries to have access to the iFuse procedure, if it is medically necessary, in the following thirteen states: Alaska, Arizona, California, Hawaii, Idaho, Montana, Nevada, North Dakota, Oregon, South Dakota, Utah, Washington, and Wyoming. This is the third of eight MACs in the United States to establish coverage for Medicare patients for MIS SI joint fusion.
"The decision by Noridian to cover MIS SI joint fusion further validates use of the iFuse Implant System for treating patients with SI joint dysfunction due to degenerative sacroiliitis or sacroiliac joint disruptions. More high quality clinical evidence is coming very soon and as a result, we believe that the remaining five MACs will give genuine consideration to covering SI joint fusion," said Michael Mydra, Vice President of Health Outcomes and Reimbursement.
Clinical publications have identified the SI joint as a pain generator in up to 30% of low back pain patients1,2,3,4 and the prevalence of SI joint pain in post-lumbar fusion, so called "failed back surgery" patients, has been shown to be 43%.5 Of these patients, some may have degenerative sacroiliitis or SIJ disruptions. Initial treatment options for patients with SI joint disorders typically involve non-surgical management and, when non-surgical treatment of the SI joint fails, surgical options such as the iFuse procedure may be considered.
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, provide immediate fixation and allow for biological fixation to support long term fusion. The iFuse System is intended for sacroiliac joint fusion for conditions including SI joint dysfunction that is a direct result of SI joint disruptions and degenerative sacroiliitis. As with all surgical procedures and permanent implants, there are risks and considerations associated with surgery and use of the iFuse Implant. Physicians should refer to the product labeling for a discussion of these risks and patients should talk with their doctors about these risks before deciding if the iFuse Implant is right for them.
Source : http://www.prnewswire.com/
