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Sen. Grassley Seeks More Documents From Northwestern On Edwards’ Valve Inquiry

The Iowa Republican says Northwestern Memorial Hospital may have held back materials in response to his 2008-launched inquiry into use of an Edwards Lifesciences heart valve repair device without FDA clearance or proper patient consent.

Sen. Chuck Grassley, R-Iowa, says Northwestern Memorial Hospital may have withheld certain documents in response to his investigation into allegations that patients were implanted with a non-FDA-approved or -cleared heart valve device without proper consent, and now he wants the documents to be released.

In a March 4 letter to the presidents of Northwestern University and the hospital, Grassley asked for the additional documents tied to a clinical study at the hospital...

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