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SI-Bone News

03
Jan

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 Blue Cross Blue Shield Association (BCBSA), after an extensive review of all existing peer-reviewed published clinical safety and effectiveness data, has assigned triangular implants for SI joint fusion a “Moderate” quality evidence recommendation.

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19
Jun

SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, today announced FDA clearance and full U.S. commercial launch of the iFuse-3D™ Implant (“iFuse-3D”), the first-ever 3D-printed titanium implant for use in the SI joint.
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03
Apr

SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that the highly respected journal Spine has published the 50th peer-reviewed iFuse paper titled Predictors of Outcome in Conservative and Minimally Invasive Surgical Management of Pain Originating from the Sacroiliac Joint – a Pooled Analysis.

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01
Sep

SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a patented triangular-shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced the publication of two-year results from INSITE (Investigation of Sacroiliac Fusion Treatment – NCT01681004) a landmark prospective, multicenter, randomized controlled trial (RCT) of MIS SI joint fusion with iFuse compared to non-surgical management (NSM).

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19
Jul

SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), announced the publication of the 40th peer-reviewed paper on SI joint fusion with iFuse. The paper, titled Durable intermediate to long-term outcomes after minimally invasive transiliac sacroiliac joint fusion using triangular titanium implants, shows mean 3.7-year follow-up for minimally invasive SI joint fusion was associated with improved pain, low disability scores, improved ability to perform activities of daily living and low revision rates.

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20
Jun

SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System®, a triangular-shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced the closing of a $20 million round of growth capital financing. New investor Arboretum Ventures led the round and all of SI-BONE’s existing major investors participated.

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14
Jun

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 the U.S. Food and Drug Administration (FDA) has cleared a 510(k) to allow modification of its indication statement noting that clinical studies have demonstrated that treatment with the iFuse Implant System improve pain, patient function and quality of life. The revised indication statement is based on extensive safety and effectiveness data from retrospective studies as well as three prospective clinical trials.

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