Cardiovascular Devices Lead FDA Breakthrough Device Designation
The U.S. Food and Drug Administration (FDA) stated cardiovascular devices make up the largest number of technologies accepted into the FDA Breakthrough Devices Program. Created in 2018, the Breakthrough Devices Program provides for certain medical devices to be available for patients and healthcare providers in a timely manner by speeding up their development, assessment and regulatory review.
According to the FDA, it speeds up the review process while preserving statutory standards for premarket approval (PMA), 510(k) clearance and De Novo marketing authorization. The Breakthrough Devices Program designation replaces the Expedited Access Pathway and Priority Review for medical devices. The FDA considers devices granted designation under the Expedited Access Pathway to be part of the Breakthrough Devices Program.
Devices are eligible for this program if they are considered breakthrough technology; no approved alternatives exist; they offer significant advantages over existing alternatives; and they provide more “effective treatment or diagnosis of life-threatening or irreversibility debilitating human disease or conditions.”
The list of 50 Breakthrough Devices authorized for marketing includes 10 cardiovascular devices. Of interest is the GORE® TAG® Thoracic Branch Endoprosthesis (TAG).
