Docs express concern over recommendation on nonroller pumps

01/7/2013 | MedPage Today (free registration)

If the FDA follows a panel recommendation, the manufacturers of certain nonroller blood pumps for hemodynamic support will have to to go through the full premarket approval process, something that worries clinicians. "If the FDA reclassified these devices and required a premarket approval, it might put a taint on them and doctors would be less comfortable using them and patients would question them," said SCAI Past President Dr. George Vetrovec, who spoke on behalf of the organization.

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