SI-BONE, Inc. Gains FDA Clearance for New Implant System
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SI-BONE, Inc. Gains FDA Clearance for New Implant System
SI-BONE, Inc. (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to providing surgical solutions for sacropelvic disorders, announces FDA 510(k) clearance of the iFuse TORQ TNT™ Implant System (TNT). The TNT implant system is designed to meet the specific anatomical and bone mineral density needs of the sacrum and ilium and will serve as the next generation technology for pelvic fragility fracture fixation and sacroiliac joint fusion.
Innovative Design of the TNT Implant System
TNT includes a porous threaded implant with lengths capable of spanning the posterior pelvis, passing through the ipsilateral ilium, sacrum, and into the contralateral ilium (“through and through”). This innovative design aims to improve early fixation and reduce the rate of screw backout, allowing for early patient weight-bearing and mobilization.
Expert Insights on the TNT Device
Charles Moon, MD, Director of Orthopedic Trauma at Cedars-Sinai, states that the current cannulated screws are outdated, originally designed for hip fractures. The adaptation of longer screws for pelvic fractures has led to significant issues, particularly among geriatric patients, including screw loosening and postoperative pain. With the introduction of TNT, a system specifically designed for sacropelvic anatomy, the risk of screw backout may be reduced, which should decrease the need for additional surgeries.
FDA Breakthrough Device Designation
The FDA has awarded the TNT designation as a Breakthrough Device, recognizing its potential to provide more effective treatment for pelvic fragility fractures than the traditional methods. Laura Francis, CEO of SI-BONE, highlighted the significance of this designation and shared how it reflects their commitment to developing solutions addressing critical clinical needs.
About SI-BONE, Inc.
SI-BONE (NASDAQ: SIBN) is a global leader in technology for surgical treatment of sacropelvic disorders. Since pioneering minimally invasive surgery of the SI joint in 2009, it has supported over 3,900 surgeons in performing over 100,000 sacropelvic procedures. The company has established a strong body of clinical evidence, including randomized controlled trials and numerous peer-reviewed publications, positioning itself at the forefront of surgical innovation.
Contact Information
For additional information about SI-BONE and its products, reach out to investor contact Saqib Iqbal at investors@si-bone.com.
Frequently Asked Questions
What does the FDA clearance mean for SI-BONE, Inc.?
The FDA clearance allows SI-BONE to market the iFuse TORQ TNT Implant System, enhancing treatment options for pelvic fractures.
How does the TNT implant system differ from previous devices?
The TNT system is specifically designed for sacropelvic anatomy, using a porous threaded structure to improve fixation and reduce complications.
What is Breakthrough Device Designation?
It is a designation by the FDA indicating that a device has the potential to offer significant benefits over existing treatments.
Who benefits from the new TNT system?
Primarily patients with pelvic fragility fractures, especially the elderly, will benefit from improved surgical outcomes and recovery times.
How many surgeons have used SI-BONE’s technologies?
Over 3,900 surgeons have utilized SI-BONE’s surgical solutions, demonstrating the company’s strong presence in this medical field.
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