Obvius Robotics announced today that the FDA granted breakthrough device designation for its Certa access system for central venous catheterization (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. According to a news release, complication rates vary, ranging from 4% to 11%. Obvius Robotics said this underscores a significant need for better and more consistent outcomes.
Sunrise, Florida-based Obvius designed the system to incorporate robotics as well. It aims to improve the accuracy, safety and consistency of accessing targeted anatomy. In CVC, the company believes Certa could aid clinicians of varying levels of training and experience. The company said it should assist in safely and effectively achieving vascular access.
Certa remains investigational as Obvius readies a submission to the FDA for market clearance.
President and CEO Russell Seiber says the company wants to become the new standard of care for CVC access.
“We are excited that 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,” Seiber said.
