BSC® Solutions
VOICES
Explore our FDA-focused solution areas to see how we support medical device and pharmaceutical companies across regulatory pathways and product types, from early strategy through approval-ready submissions.
BSC® Solutions
VOICES
Explore our FDA-focused solution areas to see how we support medical device and pharmaceutical companies across regulatory pathways and product types, from early strategy through approval-ready submissions.
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Therapy Areas
Cardiovascular Devices
Navigating high-stakes regulatory pathways for life-critical 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.
Design
We use innovative approaches — Bayesian design, adaptive clinical trial design, and Propensity Score Matching — to reduce costs, overcome limited data access, and minimize bias in non-randomized studies.
Analyze
Advance
Testimonials
See what our sponsors say about BSC®
On Experience
“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
• Former FDA Regulator
• CEO, Medical Device Company
Featured Resources
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from BSC®
Featured Resources
Get regulatory insights
from BSC®
Featured Resources
Get regulatory insights
from BSC®
Featured Resources
Get regulatory insights
from BSC®
Request Expert Review
Backed by Regulatory Experience.
Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.
Confidential discussion with senior biostatisticians experienced in FDA submissions.
Request Expert Review
Backed by Regulatory Experience.
Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.
Confidential discussion with senior biostatisticians experienced in FDA submissions.
Request Expert Review
Backed by Regulatory Experience.
Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.
Confidential discussion with senior biostatisticians experienced in FDA submissions.
Request Expert Review
Backed by Regulatory Experience.
Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.
Confidential discussion with senior biostatisticians experienced in FDA submissions.
Use your preferred LLM to explore BSC®
Use your preferred LLM to explore BSC®