SI-Bone's iFuse Implant System Cleared by the US FDA.
M2 PHARMA-November 9, 2015-SI-Bone's iFuse Implant System Cleared by the US FDA
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- The US Food and Drug Administration has cleared US-based medical device company SI-Bone, Inc.'s iFuse Implant System, a minimally invasive surgical device indicated for fusion for certain disorders of the sacroiliac joint, to include in its indication statement that "Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function and quality of life at 12 months post-implantation," the company said.
This addition was based on prospective and retrospective clinical studies demonstrating consistent improvement in pain, patient function and quality of life at 12-months in patients treated with iFuse.
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.
The company develops, manufactures and markets minimally invasive products for patients with these disorders.
SI-Bone received original 510(k) clearance in November 2008from the Food and Drug Administration to market its iFuse Implant System.
The CE mark for European commercialisation was obtained in November 2010.
SI-Bone's 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.
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 six months.
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