The Aortix system of Procyrion Inc. has secured the Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). It is a percutaneous circulatory support system for medical-controlled chronic heart failure patients hospitalized for acute decompensated heart failure (ADHF) with worsening renal function.
Breakthrough device designation is given to those medical devices and device-led combination products which provide a more efficient therapy of life-threatening or irreversibly debilitating illnesses. This helps the manufacturers to speed up the development, assessment and review of their medical devices to provide their timely access to patients and healthcare providers. Breakthrough device designation gives the benefit of frequent interactions and feedback from FDA during the premarket review phase.
Procyrion is now expecting prioritized review from FDA for its Aortix system’s submissions. They are also eligible for coverage and increased payments meant for Breakthrough designated devices after changes were introduced by the Centers for Medicare and Medicaid Services (CMS) for the same.
Aortix provides circulatory support of up to seven days for chronic heart failure patients hospitalized for ADHF, have worsening renal function and does not respond to medical management.
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