Obvius RoboticsTM announced that U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for CERTATM Access System for central venous catheterization (CVC).
CERTATM breakthrough device expedites the innovative technologies that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The goal of this device is to help patients have more timely access to these medical devices by expediting their development, assessment and review.
Central venous catheterization (CVC) is performed over 20 million times worldwide each year, but the outcomes can differ based on the clinician's training and experience.
This procedure involves accessing a major vein (such as the internal jugular, subclavian, or femoral vein) to insert a multi-lumen catheter. This catheter is used for the rapid replacement of blood volume, administration of emergency medications and pain relief, and monitoring of hemodynamics.
Complication rates can vary widely, ranging from 4% to 11%, highlighting the critical need for improved and more consistent patient outcomes.
CVC procedures are required for variety of conditions and patients for life saving care every single day. This device will improve care settings by democratizing vascular access procedures.
Source: https://cdn.prod.websitefiles.com/644ffa2e8f0940f73eb77190/66cd5f89933840ec666d06c7_Breakthrough%20Press%20Release%20Final.pdf
