A meeting of the Circulatory System Devices Panel was held on March 17 & 18, 2004. On March 17, 2004, the Panel discussed, made recommendations, and voted on a premarket approval application supplement (P030011) for the Syncardia Systems, Inc., CardioWest Total Artificial Heart.
The device is indicated for bridge to transplant usage in cardiac transplant-eligible candidates at risk of imminent death from non-reversible biventricular failure and replaces the patient’s native ventricles and valves. The device is intended for use inside the hospital.
The Panel voted (10-1) that the application be found ‘approvable with conditions’. The Panel’s conditions included a year long postmarket study, limiting use of the device to cardiac transplant centers and adding a contraindication that the device should not be used in patients in whom it would not fit. The Panel recommended a contraindication for patients who cannot receive anticoagulant therapy and a warning that safety was not assessed in those patients who are not candidates for antiplatelet therapy. The Panel further recommended that surgeons be required to view a human transplant with the device before attempting their own procedure.
On March 18, the panel heard presentations by FDA and numerous public speakers regarding Aortic Anastomotic Devices. The FDA requested recommendations from the Panel regarding the type of data and study required to effectively evaluate performance of these devices. The panel suggested that the safety and effectiveness data required for sutures should also be applied to these devices with patency evaluated by angiography as the primary requirement for evaluation of effectiveness. The Panel felt that one year postmarket follow up of devices was appropriate and recommended against patients serving as their own controls in these studies. The Panel further suggested that Data Safety Monitoring Boards and Core Labs would be helpful in analyzing data for these studies.
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