Key Issues in Clinical Development for Interventional CV Devices | Page 2

Key Issues in Clinical Development for
Interventional Cardiovascular Devices
Introduction »

In an analysis of 78 CV devices approved
via the FDA premarketing authorization
(PMA) process between 2000 & 2007,
36% had no US study sites. 5

Cardiovascular disease (CVD), already the leading cause of death worldwide,
continues to become more prevalent in both developed and emerging nations. 1
In the US and Europe, CVD is driven by a rapidly aging population and everincreasing rates of obesity and/or type 2 diabetes. In low- and middle-income

Figure 1. Interventional
Cardiovascular Device Overview

2, 3

countries, growing economies, the popularization of a “Western” lifestyle, and
high rates of tobacco use have contributed to significant increases in several
chronic diseases, including CVD.
The prevention and treatment of CVD are big business, projected to generate
worldwide revenue of approximately $194 billion in 2012. While much of the total
can be attributed to cardiovascular (CV) drugs, CV devices contribute an estimated
$50 billion annually.2 Despite their common goal of addressing CVD, drugs and
devices are very different entities with separate approval processes and distinct
needs within a clinical development program.
Compared with pharmaceuticals, interventional CV devices tend to have shorter
technology cycles (and, thus, become obsolete much faster) and typically require
far less clinical data for marketing approval.3
In this paper, we discuss clinical development for high-risk interventional CV devices
(eg, valves, stents, heart failure assistance devices) by focusing on 5 key issues:

• Regulatory considerations

• Site selection

• Data management and monitoring

• Global standards of care

• Operational considerations

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