device success
Achievement of successful deployment and positioning of a medical device (such as a stent) according to predefined technical criteria without device-related complications.
Full Definition
Device success is a procedural endpoint commonly used in cardiovascular device trials, particularly for percutaneous coronary interventions and structural heart procedures. The definition typically includes successful device delivery, deployment, and positioning with achievement of intended performance parameters such as residual stenosis <30%, no device malfunction, and absence of device-related adverse events during the procedure. Device success rates are distinguished from procedural success, which may include additional clinical criteria, and clinical success, which encompasses longer-term outcomes. Standardized definitions of device success enable consistent reporting and comparison across different studies and devices.
Usage
Usage note: Define specific criteria for device success in methodology section as definitions may vary between device types.
In Context
- "Device success was achieved in 96.8% of attempted procedures with no cases of device malfunction." — Procedural outcomes
- "The primary safety endpoint included device success rate and freedom from device-related adverse events at 30 days." — Study endpoints