New Indications Embody Use with a Broad Class of Commercially Obtainable Rods
SANTA CLARA, Calif., Dec. 27, 2022 (GLOBE NEWSWIRE) — SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical gadget firm devoted to fixing musculoskeletal problems of the sacropelvic anatomy, at this time introduced an extra FDA clearance for iFuse Bedrock Granite®. New cleared indications embody use with all kinds of commercially obtainable pedicle screw system rods.
Grownup spinal deformity is a posh scientific downside to deal with, with lumbopelvic fixation failure charges reported at 24%.1 Surgeons have adopted completely different methods involving preoperative planning to enhance spinal alignment, biologics, and next-generation pelvic fixation implants to assist enhance surgical outcomes. SI-BONE launched iFuse Bedrock Granite in Might 2022 to handle a few of these points. The implant is usually used each to immobilize and fuse the sacroiliac (SI) joint and to function foundational assist on the base of a spine fusion assemble. The preliminary clearance included a sign to be used with a single producer’s pedicle screw system. The expanded indications embody use with a variety of rods which are generally utilized in multilevel spine fusion surgical procedures. The expanded indications will enable surgeons to make use of their most well-liked strategies and implant methods with confidence together with iFuse Bedrock Granite as the muse for his or her assemble.
“Many sufferers with spinal deformity require a radical surgical plan and a wide range of implant options to assist present the most effective consequence,” stated Robert Eastlack, MD, Orthopedic Surgeon, Scripps Hospital. “By utilizing iFuse Bedrock Granite on the base of my spinal constructs, I’m offering my sufferers with probably the most superior know-how obtainable.”
“Since launch, Granite has develop into the popular implant for surgeons as they incorporate SI joint fusion into their pelvic fixation constructs” stated Laura Francis, CEO of SI-BONE. “We consider that this expanded clearance will assist enhance the variety of surgeons who deal with their sufferers with this breakthrough gadget.”
References
- Eastlack RK, et al. Backbone. 2022 Jul 15;47(14):986-994.
SI-BONE, Inc. (NASDAQ: SIBN) is a world chief in know-how for surgical therapy of musculoskeletal problems of the sacropelvic anatomy. Since 2009, when SI-BONE launched the iFuse Implant System for minimally invasive surgical procedure of the SI joint, almost 3,000 surgeons have carried out a mixed complete of greater than 75,000 SI joint fusion procedures. A novel physique of proof, supporting the iFuse Implant System, together with two randomized managed trials and over 100 peer reviewed publications, has enabled a number of authorities and personal insurance coverage payors to determine near-universal protection of minimally invasive SI joint fusion, together with many payors that cowl the process completely when carried out with the iFuse Implant System. Supported by this proprietary reimbursement benefit, SI-BONE has actively leveraged its market management place lately to additional scientific analysis, and evolve and commercialize novel surgical therapy options for SI-Joint ache, sacropelvic and pelvic fixation, and pelvic trauma.
For extra info on the corporate or the merchandise together with dangers and advantages, please go to www.si-bone.com.
SI-BONE, iFuse Implant System, iFuse TORQ, Bedrock, and iFuse Bedrock Granite are registered emblems of SI-BONE, Inc. ©2022 SI-BONE, Inc. All Rights Reserved.
Ahead Wanting Statements
The statements on this press launch concerning expectations of future occasions or outcomes, together with SI-BONE’s expectations of continued growth of the marketplace for its iFuse Bedrock Granite product, contained on this press launch are “forward-looking” statements. These forward-looking statements are based mostly on SI-BONE’s present expectations and inherently contain vital dangers and uncertainties. These dangers embody SI-BONE’s means to broaden the marketplace for and user-base of iFuse Bedrock Granite, its means to introduce and commercialize new merchandise and indications, its means to keep up favorable reimbursement for procedures utilizing its merchandise, its means to handle dangers to its provide chain, and the longer term impression the COVID-19 pandemic can have on the power and need of sufferers and physicians to endure procedures utilizing the iFuse Bedrock Granite Implant System. Precise outcomes and the timing of occasions may differ materially from these anticipated in such forward-looking statements on account of these and different dangers and uncertainties, lots of that are described within the firm’s most up-to-date filings on Type 10-Ok and Type 10-Q, and the corporate’s different filings with the Securities and Trade Fee (SEC) obtainable on the SEC’s Web web site (www.sec.gov), particularly below the caption “Danger Elements”. SI-BONE doesn’t undertake any obligation to replace forward-looking statements and expressly disclaims any obligations or enterprise to launch publicly any updates or revisions to any forward-looking statements contained herein, besides as required by legislation.
Media Contact:
Nikolas Kerr, Sr. Vice President of Product, Enterprise Growth and Advertising and marketing
nkerr@si-bone.com
Investor Contact:
Saqib Iqbal
buyers@si-bone.com
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