SI-BONE, Inc. is a medical device company, which engages in the provision of a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint for treatment of musculoskeletal disorders of the sacropelvic anatomy. It offers a proprietary minimally invasive surgical implant system, called iFuse, used to fuse the sacroiliac joint to treat sacroiliac joint dysfunction that often causes severe lower back pain. The company was founded by Mark A. Reiley and Jeffrey W. Dunn on March 18, 2008 and is headquartered in Santa Clara, CA.
相关临床试验
13
4 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2008
进行中（未招募）
3
23.1%
已完成
6
46.1%
尚未招募
1
7.7%
招募中
1
7.7%
终止
2
15.4%
暂无批准数据
- Smith+Nephew has signed a distribution agreement with SI-BONE to offer the innovative iFuse TORQ portfolio for percutaneous pelvic fracture fixation procedures. - The partnership centers on iFuse TORQ TNT, which received FDA Breakthrough Device Designation for more effective pelvic fracture treatment compared to traditional cannulated screws. - The collaboration expands Smith+Nephew's trauma portfolio and strengthens its position in high-frequency, high-impact trauma procedures through SI-BONE's established technology platform. - iFuse TORQ TNT is eligible for Medicare New Technology Add-on Payment, potentially providing up to $4,136 in additional reimbursement per procedure for hospitals.
- SI-BONE's iFuse TORQ TNT implant system has received FDA 510(k) clearance, offering a novel solution for pelvic fragility fractures. - The TNT system is designed to address the specific anatomical and bone mineral density needs of the sacrum and ilium, potentially improving treatment outcomes. - TNT's design aims to enhance early fixation and reduce screw backout, facilitating earlier patient weight-bearing and mobilization post-surgery. - The sacroiliac joint fusion market is projected to grow significantly, with SI-BONE's advancement positioning it well to address unmet clinical needs.
