Obvius Robotics announced today that it successfully completed the first human cases with its Certa Access System.
Led by Dr. Adrian Ebner, a team at The Sanatorio Italiano in Asuncion, Paraguay, conducted the cases. The team successfully placed central venous catheters (CVC) during 19 procedures using Certa.
Weston, Florida-based Obvius Robotics designed its Certa system to combine image guidance and precise, targeted needle placement. The handheld device enables clinicians to quickly and reliably identify target structures such as blood vessels. They can then rapidly gain access for procedures such as CVC placement in the subclavian and jugular veins.
According to a news release, the team reported a median access time under three minutes.
“We know that early central venous catheter insertion yields the best results in reducing mortality and hospitalization in acutely ill ICU and ER patients,” said Dr. William Cohn, chief medical officer of Obvius Robotics and inventor of the Certa Access System. “Certa enables clinicians of various levels of experience to quickly and reliably treat these patients, and in so doing, democratizes and standardizes a common procedure that today requires a certain level of skill and experience.”
The development-stage device enables clinicians to single-handedly target anatomical structures. They can access these structures with the push of a button, using a proprietary targeting system and needle assembly. Certa remains unavailable commercially but Obvius Robotics has plans to pursue regulatory clearance and commercialization.
“This successful first-in-human study comes after two years of rigorous work proving the design and value proposition in a preclinical setting,” said Russell Seiber, CEO and president of Obvius Robotics. “We hope this will mark an important milestone in bringing this potentially groundbreaking technology to patients on a global scale.”
