RIVANNA Secures Significant NIH Funding for Innovative Pediatric Solution
RIVANNA®, a pioneer in imaging-based medical technologies, has recently been granted a $2.21 million Small Business Innovation Research (SBIR) grant. This funding from the National Cancer Institute (NCI) supports their groundbreaking work on an ultrasound guidance system designed to aid pediatric lumbar punctures on the Accuro® 3S platform.
The Importance of Lumbar Punctures in Pediatric Care
Lumbar punctures are critical procedures in the treatment of acute lymphoblastic leukemia (ALL), which is recognized as the most prevalent childhood cancer, accounting for about 25% of pediatric cancer cases. These procedures are vital for confirming diagnoses and administering intrathecal chemotherapy. Due to the nature of the disease, children undergoing treatment may need to have up to 20 lumbar punctures over a typical two-year period.
Challenges Associated with Traditional Lumbar Punctures
Despite their significance, traditional lumbar punctures are often fraught with challenges, leading to traumatic lumbar punctures (TLPs) that occur when cerebrospinal fluid is contaminated with blood. Research indicates that as many as 38% of lumbar punctures may result in TLPs, which are typically associated with adverse patient outcomes. These complications are often exacerbated by procedural difficulties, especially for very young children or those with a higher body mass index (BMI).
To enhance the success rates of lumbar punctures, fluoroscopy is sometimes employed. However, the use of fluoroscopic guidance introduces risks from cumulative radiation exposure, a particularly concerning issue for pediatric patients who undergo numerous procedures. Although studies have shown that ultrasound guidance can significantly lower TLP rates while eliminating radiation exposure, traditional training and workflow complexities have kept blind palpation and fluoroscopy as the standards of care.
The Innovative Accuro 3S Platform
In response to this ongoing challenge, RIVANNA is developing advanced pediatric features within their Accuro 3S imaging platform—an innovative, compact, and AI-enabled ultrasound system. The Accuro 3S integrates state-of-the-art hardware with intelligent algorithms to automatically identify spinal anatomy and pinpoint the optimal needle insertion site, even in patients with challenging anatomies.
This advanced platform boasts novel Dual-Array™ transducer technology, which facilitates a “through-the-probe” needle trajectory. Additionally, RIVANNA is working on a single-use, sterile accessory that will secure the ultrasound probe in place on the patient's back. This innovation allows clinicians to devote their full attention to controlling the needle and providing necessary tactile feedback during the procedure.
Tailored for Diverse Pediatric Needs
The Accuro 3S system is being engineered to cater to a wide variety of pediatric body sizes, ranging from infants with delicate anatomies to adolescents who might have a higher BMI. The design minimizes the learning curve for healthcare professionals, facilitating proficiency in ultrasound guidance after just a few supervised attempts. By reducing both failed attempts and the occurrence of TLPs, the company aims to enhance treatment outcomes and improve survival rates for children with ALL, while also boosting satisfaction for both patients and providers.
Dr. Paul Sheeran, Director of Research and Development at RIVANNA, expressed optimism about the project, stating that it is a significant advancement towards providing safer, more effective spinal interventions for pediatric patients facing cancer treatments. He highlighted that the Accuro 3S utilizes proprietary AI-BoneEnhance® imaging and SpineNav-AI™ technologies, making it a precisely adapted solution for pediatric ALL cases.
Collaborative Development and Future Goals
The preclinical development phase will focus on incorporating AI features that meet the unique needs of pediatric patients. Collaborative studies aimed at evaluating usability, accuracy, and the procedural learning curve will be pivotal in ensuring that the Accuro 3S effectively addresses clinical requirements. Acknowledging their clinical collaborators is essential for RIVANNA, reflecting the teamwork involved in this vital initiative.
About RIVANNA
RIVANNA® stands at the forefront of medical device innovation, specializing in the development and manufacturing of pioneering imaging-based technologies. The company’s base in Charlottesville, VA, propels RIVANNA's commitment to enhancing global healthcare standards. Their focus spans early to late-stage imaging solutions tailored for point-of-care spinal needle interventions and musculoskeletal diagnostics. Innovation drives RIVANNA to continuously uplift the quality of patient care through advanced medical technologies.
Frequently Asked Questions
What is the purpose of the $2.21 million NIH grant awarded to RIVANNA?
The grant will support the development of an ultrasound guidance system for pediatric lumbar punctures on the Accuro® 3S platform.
How do lumbar punctures impact children with acute lymphoblastic leukemia?
Lumbar punctures are vital for diagnosing and administering treatment for ALL, and children may undergo multiple procedures throughout their treatment.
What challenges do pediatric patients face during traditional lumbar punctures?
Traditional lumbar punctures can lead to traumatic lumbar punctures, affecting up to 38% of cases, particularly for younger patients or those with higher BMI.
How does the Accuro 3S platform improve lumbar puncture procedures?
The Accuro 3S uses AI and innovative technology to enhance precision, reduce complications, and streamline the learning curve for clinicians.
What does RIVANNA aim to achieve with this project?
RIVANNA aims to provide safer, more effective interventions for pediatric oncology patients, improving treatment outcomes and enhancing patient and provider experiences.
