SANTA CLARA, Calif., Aug. 20, 2024 (GLOBE NEWSWIRE) — SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical system firm devoted to offering surgical options for sacropelvic issues, proclaims FDA 510(ok) clearance of the iFuse TORQ TNT™ Implant System (TNT). The TNT implant system is designed to satisfy the precise anatomical and bone mineral density wants of the sacrum and ilium and can function the following technology expertise for pelvic fragility fracture fixation and sacroiliac joint fusion.
TNT features a porous threaded implant with lengths able to spanning the posterior pelvis, passing by means of the ipsilateral ilium, sacrum, and into the contralateral ilium (by means of and thru, “TNT”). TNT was awarded Breakthrough Gadget Designation (BDD) by the FDA. In designating TNT as a Breakthrough Gadget, the FDA decided that it has the potential to offer more practical remedy of pelvic fragility fractures than the present customary of care, cannulated screws. TNT is designed to enhance early fixation and scale back the speed of screw backout, which can permit for early affected person weight-bearing and mobilization.
In response to Charles Moon, MD, Director of Orthopedic Trauma at Cedars-Sinai, “The present easy stainless-steel cannulated screws we’re utilizing within the pelvis have been designed many years in the past for fixing hip fractures. When trauma surgeons started modernizing their strategies for pelvic fracture fixation, they merely began utilizing longer screws. Quite a few scientific research have proven important points with this technique, particularly within the geriatric inhabitants. Screw loosening may cause ache, which might gradual a affected person’s progress postoperatively and should require a second surgical procedure. As surgeons we actually wish to keep away from second surgical procedures within the aged. With TNT, there may be now a system designed particularly for the sacropelvic anatomy which will scale back the speed of screw backout on this affected person inhabitants. The implant is accompanied by instrumentation to match trendy surgical strategies. I’m very excited for the numerous sufferers who will profit from this new expertise.”
“We’re happy the FDA acknowledged TNT as a Breakthrough Gadget. The variety of folks bedbound from ache associated to pelvic fragility fractures is giant and rising,” stated Laura Francis, CEO of SI-BONE. “Because the chief within the sacropelvic house we’re honored to have the ability to assist surgeons get their frail and aged sufferers again to mobility sooner, by offering the primary anatomy-specific system designed to satisfy the biomechanical challenges introduced by pelvic fragility fractures. After iFuse Bedrock Granite, which additionally was a Breakthrough Gadget, that is our second system to obtain the designation. This highlights our potential to develop a platform of distinctive options that focus on giant unmet scientific wants.”
About SI-BONE, Inc.
SI-BONE (NASDAQ: SIBN) is a world chief in expertise for surgical remedy of sacropelvic issues. Since pioneering minimally invasive surgical procedure of the SI joint in 2009, SI-BONE has supported over 3,900 surgeons in performing a complete of greater than 100,000 sacropelvic procedures. A novel physique of scientific proof helps the usage of SI-BONE’s applied sciences, together with two randomized managed trials and over 135 peer reviewed publications. SI-BONE has leveraged its management in minimally invasive SI joint fusion to commercialize novel options for adjoining markets, together with grownup deformity, spinopelvic fixation, and pelvic trauma.
For extra data on the corporate or the merchandise together with dangers and advantages, please go to www.si-bone.com.
iFuse TORQ, iFuse Bedrock Granite, and SI-BONE are registered emblems, iFuse TORQ TNT is a trademark of SI-BONE, Inc. ©2024 SI-BONE, Inc. All Rights Reserved.
Investor Contact: Saqib Iqbal buyers@si-bone.com
Discussion about this post