Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting on the Edwards SAPIEN™ Transcatheter Heart Valve

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Transcatheter aortic valve replacement (TAVR) has been developed as a novel approach for the treatment of high-risk patients with aortic stenosis (AS). Although surgical aortic valve replacement is the standard of care for patients with symptomatic AS, it is associated with poor outcome when applied to patients with extreme operative risk. This subset of patients is usually deferred from surgery and has done poorly with medical therapy alone with or without balloon aortic valvuloplsty (BAV).1–4 The Edwards SAPIEN™ transcatheter heart valve (THV) technology aims to provide treatment for patients with severe, symptomatic AS who are deemed inoperable. On July 20, 2011, the Food and Drug Administration's (FDA) Circulatory System Devices Panel reviewed the first transcatheter aortic valve system, Edwards SAPIEN™ THV premarket approval application. Meeting materials can be accessed at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm240575.htm. The premarket approval application was based on data from the pivotal US randomized clinical trial, Placement of Aortic Transcatheter Valves (PARTNER),5,6 which comprised two independent cohorts of patients (high-risk and inoperable patients). For the purpose of the application, only patients in the inoperable cohort (Cohort B) who were randomized to standard therapy versus TAVR were submitted and subsequently presented to the FDA seeking device approval. Following is a summary of the discussions and recommendations made during the Circulatory System Devices Advisory Panel meeting, along with some important insights regarding the clinical use of the Edwards SAPIEN™ THV in a postapproval era. The proposed indication of use stated, “The Edwards SAPIEN Transcatheter Heart Valve, model 9000TFX, sizes 23 mm and 26 mm, and RetroFlex 3 Delivery System are indicated for transfemoral delivery in patients with severe AS who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing comorbidities would not preclude the expected …