Breakthrough Device Designation expedites the review of innovative technologies that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. To qualify for a Breakthrough Device Designation, a device technology must show that it has the potential to provide more effective treatment than current standards of care. The goal of the program is to help patients have more timely access to these medical devices by expediting their development, assessment and review.

CVC procedures are performed over 20 million times per year globally, yet outcomes are varied dependent upon the training and experience of the clinician. 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. Complication rates vary significantly, ranging from 4% to 11%, underscoring a significant need for better and more consistent outcomes.