A meeting of the Circulatory System Devices Panel was held on November 30, 2007. The Panel discussed the submission, made several specific recommendations, and voted on the premarket approval application (P060040) for the Thoratec HeartMate II Left Ventricular Assist System.
The sponsor was seeking the following indications for use statement for the device: “The HeartMate II Left Ventricular Assist System (LVAS) is intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. The HeartMate II LVAS is intended for use both inside and outside the hospital.”
The HeartMate II LVAS consists of an implanted continuous axial flow blood pump and external components. The blood pump has one moving part, the rotor assembly that spins on bearings located at either end of the assembly. Blood enters the pump from the apex of the left ventricle and exits the blood pump to the ascending aorta. One single moving impeller inside the blood pump imparts energy for the blood to be ejected to the systemic circulation. The HeartMate II can be powered by batteries or AC wall power.
The pivotal study consisted of a total of 133 patients at 26 investigational centers in the United States between March 2005 and May 2006. Enrollment was limited to end-stage, NYHA Class IV heart failure patients listed for transplant without severe end-organ damage that would preclude heart transplantation. Seven (7) patients with a body surface area (BSA) < 1.5 m2 were analyzed separately in the Small BSA Cohort group. Therefore, the 126 patients from this group with BSA ≥ 1.5 m2 represent the Primary Study Cohort.
The sponsor also presented data from their continued access protocol (CAP). This group of patients allowed investigators to continue implanting the device as the sponsor was analyzing their data and during FDA’s review of the data. Those patients enrolled in the CAP followed the identical protocol as those patients in the pivotal study. A total of 139 CAP patients were implanted from May 25, 2006 to March 16, 2007. All patients are included in the analysis except for one patient who had previously been implanted with the HeartMate XVE. Thus, the CAP cohort included 138 patients. As of March 16, 2007, 58 patients had reached an endpoint. Eight patients enrolled in the CAP were also considered small patients because their BSA was < 1.5 m 2. Thus, a total of 15 small BSA patients were enrolled with only 10 patients reaching an endpoint as of March 16, 2007.
Following presentations by the sponsor and the FDA, and after extensive deliberation, the Panel voted unanimously in favor of “Approvable with Conditions.” The recommended conditions of approval are summarized as follows:
- A post-approval study to include adequate collection of data regarding both gender and BSA.
- The post-approval study must have a concurrent comparator.
- Labeling changes to reflect the Primary Study Cohort, the Continued Access Protocol and the Small BSA Cohort Data.
- A contraindications statement to state that no patient shall receive this device if they cannot be on anticoagulation medications.
- The sponsor is required to capture bleeding and anticoagulation data in their post-approval study.
- A statement is to be placed in the label to show that this device has no data for BSA < 1.3m2.
Contact: James Swink, Executive Secretary,
(240) 276-4179 James.Swink@fda.hhs.gov
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