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This article was originally published in Clinica
Italian cardiovascular specialist Sorin has taken a step closer to FDA approval of its Perceval S sutureless aortic tissue valve by getting the go-ahead for a US trial of the device. The non-randomized study will enroll patients with aortic stenosis in up to 25 US centers and, if successful, will be used to support a premarket approval (PMA) application.
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