Abbott’s MitraClip and TriClip Devices Supported by New Safety and Effectiveness Data

August 28, 2022—Abbott announced the presentation of late-breaking data that reinforce the safety and effectiveness of the company’s MitraClip and TriClip devices in treating leaky valves in patients with mitral regurgitation (MR) and tricuspid regurgitation (TR).

The findings included the first report of the TriClip in patients with severe TR from the TRILUMINATE pivotal clinical trial and real-world outcomes from the COAPT postapproval study (PAS) of the MitraClip in patients with secondary MR. The data were presented at the European Society of Cardiology’s ESC Congress 2022 held August 26-29 in Barcelona, Spain.

According to Abbott, the TRILUMINATE pivotal study is the first randomized controlled clinical trial evaluating the effectiveness and safety of transcatheter edge-to-edge repair with TriClip in patients with severe TR.

As outlined by the company, the data through 30 days showed the following:

• A 99% implant success rate
• At least a one-grade TR reduction in 91% of patients, with moderate or less residual TR achieved in 74% of patients
• An approximately 17-point average improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score

The company advised that COAPT PAS is the largest observational study to report real-world outcomes for 5,000 patients treated with MitraClip who have secondary MR.

Abbott stated that the COAPT PAS data through 1 year demonstrated the following:

• Significant MR reduction to ≤ 2+ in 91% of patients
• Improvements in New York Heart Association class and KCCQ score
• High freedom from all-cause mortality and heart failure hospitalization rates