FDA Breakthrough Designation Awarded to Obvius Robotics’ CERTA Access System

Obvius Robotics’ CERTA Access System for central venous catheterization (CVC) has won U.S. Food and Drug Administration (FDA) Breakthrough Device Designation.

“The goal of Obvius Robotics is to become the new standard of care for CVC access,” Obvius Robotics President/CEO Russell Seiber said. “We are excited the FDA has recognized the potential of the CERTA Access System to be a breakthrough for patients and clinicians. We believe this technology could improve care critical care settings by democratizing vascular access procedures.”
 
Breakthrough Device Designation expedites the review of innovative technologies that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. To qualify for a Breakthrough Device Designation, a device and/or technology must show it has the potential to provide more effective treatment than current care standards. The program aims to give patients more timely access to these medical devices by expediting their development, assessment, and review.
 
CVC procedures are performed globally more than 20 million times annually, yet outcomes depend on clinician training and experience. The procedure involves gaining 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 vary significantly, ranging from 4% to 11%, underscoring 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,” Obvius Robotics Chief Medical Officer William Cohn, M.D., stated. “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.”
 
The CERTA Access System is not approved for clinical use, but the company is currently preparing its FDA submission.
 
Obvius Robotics is a privately held medical device company based in South Florida with clinical offices in the Center for Device Innovation at the Texas Medical Center, Houston, that is developing technology for image-guided access of structures within the body. The platform technology, the CERTA Access System, incorporates robotics and imaging to improve the accuracy, safety, and consistency of accessing targeted anatomy. The company’s first clinical application is central venous catheter placement, a high-volume procedure in which CERTA has the potential to aid clinicians of varying levels of training and experience in safely and effectively achieving vascular access.