Cardiovascular 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.
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.
Regulatory-first biostatistics
Support built specifically for FDA-facing programs, from early feasibility through submission and post-market requirements.
Direct communication, faster turn around
Our biostatisticians write the SAP and run the analysis. One person owns both — no separate programmer, no project manager in between.
Versatile Solutions
Engage us for a focused analysis or a full submission, We size the work to the problem.
Proven FDA Experience
Hands-On Experience with FDA Pathways, statistical reviews, and regular interactions, reducing risk and rework.
WHAT CLIENTS SAY
“They listen the first time. I’ve never had to go back and respell out what I needed."
”They work to understand the problem and leverage the information that is already there.”
Former FDA Regulator
WHAT CLIENTS SAY
"Battle ground tested."
"There is nothing that David and team haven’t seen over the years – the good, bad, and ugly.”
Vice President, Clinical Operations
WHAT CLIENTS SAY
"Get stuff done when you have to do something no one else has done before."
"They aren’t afraid to tackle difficult scenarios in compressed timelines."
CEO, Medical Device Company