A US Food and Drug Administration (FDA) advisory committee (AdCom) has recommended approval of Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system.
The Circulatory System Devices Panel of the Medical Devices Advisory Committee voted 13 to 1 in favour of the system, stating that the benefits of the TriClip TEER system outweighed the risks for the treatment of people with tricuspid regurgitation.
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The TriClip TEER system is a first-of-its-kind minimally invasive device designed as a treatment for patients who require tricuspid valve repair but are not able to withstand open heart surgery. The device has been approved in multiple countries including Europe and Canada.
The AdCom’s positive recommendation was based on the data from the TRILUMINATE trial (NCT03904147), in addition to expert testimony. In the trial, 87% of patients treated with the TriClip TEER system had a significant reduction in tricuspid regurgitation, to moderate or less, at 30 days compared to 4.8% of patients in the control group. Furthermore, 50% of the patients who received the device achieved significant improvement in quality of life.
The FDA’s Circulatory System Devices Panel, which does not directly approve or reject a device but makes recommendations based on questions posed by the agency, voted unanimously that the data from the TRILUMINATE trial was enough to support device approval. The panel also voted 12 to two in favour of the trial data’s veracity in providing reasonable assurance of the TriClip TEER system’s effectiveness.
GlobalData expects the transcatheter tricuspid valve replacement market to grow from being worth $10m in 2023 to more than $2bn in 2033. The growth will be driven by the increased adoption of these devices and surgeons becoming more familiar with these procedures.
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By GlobalDataOther cardiac devices included in Abbott’s portfolio include an FDA-approved Epic Max stented tissue valve to treat aortic valve disease, Navitor transcatheter aortic valve implantation (TAVI) system for the treatment of aortic stenosis, and a CE-marked MitraClip transcatheter mitral valve repair system for minimally invasive repairs.
