US Medicare Administrator to Cover Si-Bone Implant System.
M2 PHARMA-January 5, 2015-US Medicare Administrator to Cover Si-Bone Implant System
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US-based Medicare administrative contractor Noridian Healthcare Solutions, LLC has begun covering MIS SI joint fusion, including use of US-based implant system provider Si-Bone, Inc.'s iFuse Implant System, the company said on Monday.
The change by Nordian enables more than 9m Medicare beneficiaries to have access to the iFuse procedure, if it is medically necessary, in the US states of 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.
Si-Bone said it received original 510(k) clearance in November 2008 from the Food and Drug Administration 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 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.
Si-Bone is a sacroiliac joint medical device company focused on the development of tools and products for patients with low back issues related to certain SI joint disorders.
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