Key result
Cardiovascular device postmarket surveillance requires integrated registry pathways to ensure long-term safety.
Why the study?
The regulation and surveillance of vascular devices in real-world practice presents challenges during each product's life cycle regarding safety, appropriate use, and efficacy.
Real-world surveillance using registries and quality reporting is essential to identify safety signals and ensure appropriate use of vascular devices post-FDA approval.
Clinicians should scrutinize new device data amid surveillance gaps; leaves open optimal registry integration for long-term cardiovascular safety monitoring.
Cardiovascular devices are essential for the treatment of cardiovascular diseases including cerebrovascular, coronary, valvular, congenital, peripheral vascular and arrhythmic diseases. The regulation and surveillance of vascular devices in real-world practice, however, presents challenges during each individual product's life cycle. Four examples illustrate recent challenges and questions regarding safety, appropriate use and efficacy arising from FDA approved devices used in real-world practice. We outline potential pathways wherein providers, regulators and payors could potentially provide high-quality cardiovascular care, identify safety signals, ensure equitable device access, and study potential issues with devices in real-world practice.
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Pyun et al. (2024) conducted a review in Cardiovascular diseases. Cardiovascular devices was evaluated. Postmarket surveillance of cardiovascular devices faces significant challenges, highlighting the need for integrated pathways using registries and long-term outcome evaluation to ensure safety.
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