Obvius Robotics Inc. this week said that the U.S. Food and Drug Administration has granted breakthrough device designation for its Certa Access System for central venous catheterization, or CVC.
CVC procedures require access to one of the great veins -- internal jugular, subclavian, or femoral -- to place a multi-lumen catheter for rapid replacement of blood volume, administration of emergency medicines and analgesics, and hemodynamic monitoring.
Complication rates can range from 4% to 11%, noted Obvius Robotics. The Sunrise, Fla.-based company said this underscores a significant need for better and more consistent outcomes.
"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," he added. "A breakthrough is truly needed to improve care."
Register now.
Obvius said it designed Certa to incorporate robotics as well. It aims to improve the accuracy, safety, and consistency of accessing targeted anatomy.
For CVC procedures, the company said that its system could aid clinicians of varying levels of training and experience. Obvius said it will assist in safely and effectively achieving vascular access.
Certa remains investigational as Obvius readies a submission to the FDA for market clearance. The company completed initial clinical cases for the handheld device in June 2023. It says the system allows users to quickly visualize the target vessel and advance a needle to the target location in seconds.
The company wants Certa to become the new standard of care for CVC access, said Russell Seiber, president and CEO of Obvius.
"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 critical care settings by democratizing vascular access procedures."
Obvius Robotics was founded in 2020. Seiber said he conceived the idea for Obvius Robotics when an emergent liver-failure patient required a central line placed to stabilize very low blood pressure. This is a life-saving procedure that can be challenging for physicians.
Despite significant expertise in placing these lines, the critical care physician could not successfully gain vascular access with the difficult anatomy of the patient. While the line was eventually placed, Seiber wanted to find a system to address this common problem.
Over 20 million central lines are placed globally each year, making it one of the most common medical procedures in the world, said Obvius. However, between 200,000 and 550,000 patients currently suffer from preventable complications each year, it noted.