BioStable Science & Engineering Completes Direct De Novo Application to FDA for the HAART™ 300 Aortic Annuloplasty Device

BioStable Science & Engineering, Inc. announced today that it has completed a direct de novo application to the U.S. Food and Drug Administration (FDA) for Class II designation of the HAART 300 Aortic Annuloplasty Device. Submission of the de novo request is an important milestone in BioStable’s efforts to bring the potential benefits of valve repair to U.S. patients suffering with aortic valve insufficiency. (read more)