SpineGuard's PsiFGuard Receives FDA Clearance for Sacroiliac Joint Fusion
核心洞察
SpineGuard (搜索)'s PsiFGuard (搜索), a smart drilling device for posterior sacroiliac fusion (PsiF), has received FDA 510(k) clearance for commercial use in the United States.
The PsiFGuard (搜索) device utilizes SpineGuard (搜索)'s Dynamic Surgical Guidance (DSG®) technology to enhance the accuracy of implant placement in SI joint fusion procedures.
Developed in partnership with Omnia Medical (搜索), PsiFGuard (搜索) aims to address the challenges of locating the SI joint, which is critical for successful fusion outcomes.
SpineGuard (搜索), in collaboration with Omnia Medical (搜索), has announced FDA 510(k) clearance for its PsiFGuard (搜索) device, a new smart drilling system designed to improve the precision of posterior sacroiliac fusion (PsiF) procedures. This clearance marks a significant milestone for SpineGuard's expansion in the United States and the deployment of its Dynamic Surgical Guidance (DSG®) technology.
The PsiFGuard (搜索) device leverages SpineGuard (搜索)'s proprietary DSG® technology, which uses real-time local conductivity sensing to guide the placement of bone implants. The device is specifically designed to address the challenges associated with accurately locating the sacroiliac (SI) joint during fusion surgery, a critical factor for successful outcomes.
Clinical Significance
Sacroiliac joint dysfunction (搜索) is estimated to affect more than 15% of patients with chronic lower back pain, leading to debilitating pain and reduced quality of life. The global sacroiliac joint (搜索) fusion market is substantial, reaching over $539 million in 2021 and projected to grow at a CAGR of 19% from 2022 to 2030, according to Grandview Research. The introduction of a new payment code in the United States in January 2024 for posterior sacroiliac joint fusion surgery is expected to further accelerate market growth.
Expert Commentary
Stéphane Bette, Deputy CEO and Co-Founder of SpineGuard (搜索), stated, "We are very pleased by this new clearance that will help us accelerate our growth as we continue to deliver consistently on our new product road map. The efficacy of our PsiFGuard (搜索) device in locating the SI joint was clearly demonstrated in the submitted pre-clinical testing which allowed for a smooth clearance process."
Troy Schifano, CEO and Co-Founder of Omnia Medical (搜索), added, "We’ve seen that proper placement of the implant is essential to a successful SI Joint fusion. Locating the joint is critical for this to occur but can be very challenging. However, the data SpineGuard (搜索) provided to the FDA during the clearance process has confirmed PsiFGuard (搜索) drastically enhances the accuracy of the placement of the wire guiding the implant."
Technology and Future Directions
SpineGuard (搜索)'s DSG® technology has been utilized in over 100,000 surgical procedures worldwide, with 34 peer-reviewed studies demonstrating its benefits for patients, surgeons, and hospitals. The company is focused on expanding the application of its DSG® technology to other areas, including scoliosis treatment, dental implantology, and surgical robotics. SpineGuard also plans to accelerate sales growth in the United States, roll out PsiFGuard (搜索) and other new products, and register its full product line in China during the second half of 2024.