Robotic Access System for Central Venous Catheterization Wins FDA Breakthrough Nod

Obvius Robotics, a company developing a technology platform to democratize vascular access, has earned U.S. Food and Drug Administration (FDA) breakthrough device status for its CERTA access system for central venous catheterization (CVC).
 
The company’s CERTA access system leverages robotics and imaging to boost the accuracy, safety, and consistency of accessing targeted anatomy. Its first clinical application is CVC placement, which is a high-volume procedure where it believes CERTA could help clinicians of varying training and experience levels achieve vascular access.
 
Obvius cited the varied outcomes based on CVC procedure training experience as the clinical need for CERTA. The procedure involves getting access to one of the great veins 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%, reinforcing a 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,” said William Cohn, MD, chief medical officer for 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.”
 
“The goal of Obvius Robotics is to become the new standard of care for CVC access,” added Russell Seiber, president and CEO of Obvius Robotics. “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.”