The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Obvius Robotics Inc.’s Certa Access System for central venous catheterization (CVC). This decision aligns with the apparent need for advancements in the field of vascular access. The designation aims to accelerate the development and review of the system, which Obvius believes will significantly improve patient outcomes. Alongside its robotic technology, Certa aims to reduce complications in a procedure that is critical for numerous emergency medical conditions.
Past reports on similar advancements in medical technology have highlighted the ongoing efforts to enhance the safety and efficiency of vascular access procedures. While there have been incremental improvements, the high complication rates have remained a persistent issue. This new breakthrough designation indicates a strong potential shift in how these procedures might be conducted in future, offering hope for reduced risks and better outcomes.
Certa’s Potential Impact on CVC Procedures
Obvius Robotics Inc., based in Sunrise, Fla., emphasizes that CVC procedures are essential for rapid blood volume replacement, emergency medication administration, and hemodynamic monitoring. The company cites a complication rate ranging from 4% to 11%, underscoring the need for more reliable solutions.
“CVC procedures are required for a wide variety of conditions and patients for life-saving care every single day,” stated William Cohn, M.D., chief medical officer of Obvius Robotics. “Despite this fact, the procedure still has high complication rates, and many health systems lack the expertise to reliably conduct the procedure on critically ill patients in a timely manner. A breakthrough is truly needed to improve care.”
Development and Market Prospects
Obvius Robotics has designed the Certa Access System to improve the accuracy, safety, and consistency of vascular access procedures. The company aims to support clinicians of varying skill levels in safely and effectively achieving vascular access. Having completed initial clinical cases for the handheld device in June 2023, the company is preparing for FDA market clearance.
Obvius Robotics president and CEO Russell Seiber expressed optimism about the system’s potential to become the new standard of care.
“We are excited that the FDA has recognized the potential of the Certa access system to be a breakthrough for patients and clinicians,” he said. “We believe this technology could improve care in critical care settings by democratizing vascular access procedures.”
Obvius Robotics was founded in 2020, inspired by Seiber’s experience with a critical situation involving a liver-failure patient needing a central line. Despite significant expertise, the critical care physician faced challenges due to the patient’s difficult anatomy. This experience led Seiber to conceptualize a system that could address these common issues in vascular access.
Globally, over 20 million central lines are placed annually, making it one of the most common medical procedures. However, between 200,000 and 550,000 patients still suffer from preventable complications each year. The FDA designation of Certa as a breakthrough device suggests a future direction toward minimizing these complications.
