Abbott Vascular has received tepid approval from FDA's Circulatory Systems Devices Panel for its MitraClip heart implant. While the device won regulatory approval for its premarket application, panelists shared differing opinions on the efficacy of the device.
Panelists at the FDA had no concerns about the device’s safety, voting 8-0 that the MitraClip heart implant was safe based on clinical trials. In addition, the panel voted 5-3 that the potential benefits of the MitraClip implant outweighed any potential risks. However, the panel was split 4-4 on the efficacy of the device.
Since there was a tie when voting on the efficacy of the device, the panel chair voiced an opinion to break the tie. According to the panel chair, available data did not adequately demonstrate the efficacy of the device.
John Carroll at CardioSource shared his opinion on the panel’s actions. He stated, “On one hand, there was much discussion surrounding the importance of clinical judgment, access to new treatments for inoperable patients, and potential acceptability of solid and consistent observational data with imperfect comparators. On the other, there was concern regarding the lack of strong, well-executed randomized trial data of the target patient population. The patient testimonials were compelling and in line with the data showing enhanced quality of life.”
Wednesday's Qmed Daily reported that FDA recommended against Abbott's PMA application for the MitraClip. Indeed, an FDA Executive Summary dated March 20 stated: "PMA approval is not appropriate at this time as major questions of safety and effectiveness, as well as the overall benefit-risk profile for this device, remain unanswered per the regulatory standards set forth in 21 CFR 860.7 (c)2, (d)1 and (e)1." However, the vote by the Circulatory Systems Devices Panel appears to upend this recommendation.
More news on Abbott and the MitraClip:
- Linearity Measurements for MEMS Pressure Sensors - Supplier Resource
- Dual Die Compensation for MEMS Pressure Sensors - Supplier Resource
- Special Considerations for Mounting and Handling Pressure Sensors - Supplier Resource
- Special Kind of Plastic V3 - Video
- Visimobile v6 - Video
- Corporate Video - Video