Navigating high-stakes regulatory pathways for life-critical devices
BSC brings proven cardiovascular trial experience to support your FDA strategy, from early feasibility through PMA approval. Our regulatory insight helps you anticipate FDA questions, optimize endpoint selection, and build compelling evidence packages for transcatheter valves, vascular interventions, and cardiac rhythm devices.
Cardiovascular Devices
Overview
BSC® supports cardiovascular device development from early feasibility through pivotal trials and post-market studies. Our cardiovascular expertise includes structural heart devices, coronary interventions, heart failure management systems, and vascular access technologies.
Specialized Capabilities
Time-to-event analyses for MACE endpoints. Adjudication committee integration and CEC oversight. Bayesian hierarchical models for device performance across patient subgroups. Non-inferiority margin justification for cardiovascular devices. Sequential monitoring with alpha-spending functions for cardiovascular outcomes trials.
Regulatory Experience
We have deep experience with CDRH cardiovascular device expectations, including appropriate historical controls, blinded endpoint assessment, and handling of competing risks. Our team understands the nuances of different cardiovascular indications -- from coronary artery disease to structural heart disease to heart failure.
Representative Studies
Transcatheter heart valve systems (TAVR, TMVR).
Coronary stents and drug-eluting devices.
Cardiac ablation systems.
Heart failure monitoring and management devices.
Peripheral vascular intervention devices.