Company achieves major milestone with its groundbreaking hand-held image-guided percutaneous access device
WESTON, Fla., June 8, 2023 /PRNewswire/ — Obvius Robotics, Inc., a medical device company that has developed an innovative technology platform for performing percutaneous access, today announced the successful completion of its first human cases.
The cases were conducted at The Sanatorio Italiano in Asuncion, Paraguay under the supervision of principle investigator Adrian Ebner, MD. The clinical team successfully placed central venous catheters (CVC) during 19 procedures using the company’s CERTA Access System™. This system combines image guidance and precise, targeted needle placement in a hand-held device that enables clinicians to quickly and reliably identify target structures such as blood vessels, and rapidly gain access for procedures such as CVC placement in the subclavian and jugular veins. The median time for access was under 3 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,” stated William Cohn, MD, 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 Obvius Robotics CERTA Access System is a development stage device that enables clinicians to single-handedly target anatomical structures and access them with the push of a button using a proprietary targeting system and needle assembly. While the product is not yet available for sale, the company is preparing for 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,” stated 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.”
About Obvius Robotics
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. Note: The CERTA Access System is not approved or cleared for use in patients in any geography at this time.
SOURCE OBVIUS Robotics, Inc.
