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“The FDA continues to work with manufacturers through our Breakthrough Devices Program to provide patients and healthcare providers with timely access to medical devices that have the potential to lead to a clinical improvement in patients, such as those with this irreversibly debilitating condition, while ensuring these devices meet our regulatory requirements for safety and effectiveness.” About 5.7 million people in the United States have heart failure, a condition in which the heart cannot pump enough blood to meet the body’s needs

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Scenario 2: Wrong vial assumption