SUNRISE, Fla., June 4, 2024 /PRNewswire/ — Obvius Robotics, a medical device company developing an innovative technology platform for democratizing vascular access, today announced its move into a new development and operations facility. The South Florida facility will enable Obvius Robotics to support its growth as the company prepares for clearance and commercialization.
Obvius Robotics has developed technology that can be used with minimal training or experience, initially targeting central venous catheterization (CVC) procedures. The CERTA Access System is a hand-held, image guided 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. Early clinical use of the CERTA has demonstrated a 100% access success rate (link).
As the most common interventional procedure performed in the United States, CVC is a key platform from which to launch critical medical interventions for acutely ill patients and patients requiring surgery. 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. Despite the broad use of CVC, these procedures carry a complication rate between 4% and 11% due to a lack of training and experience.
“The goal of Obvius Robotics is to democratize access, improve outcomes, and become the new standard of care in CVC,” said Russell Seiber, president and CEO of Obvius Robotics. “The new facility will not only support development and production of the CERTA Access System for CVC, but will also be a center of innovation to expand the CERTA platform into new applications”.
The CERTA Access System is not approved for clinical use at this time, but the company is currently preparing its submission to the U.S. Food and Drug Administration (FDA) for market clearance.
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.
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