MitraClip (mitral valve treatment system)

2022: Serious marriage found in devices

In early September 2022 Ministry of Health USA , he warned medical workers about problems in the MitraClip heart valves from. Abbott Laboratories The company issued an urgent fix about the issue, saying there had been an increase in complaints that the clip opens when it is fixed before and after deployment.

MitraClip, a mitral regurgitation treatment, is an important part of the structural heart disease portfolio from Abbott. In July 2022, the company's chief executive, Robert Ford, told investors that the market was still fairly underperformed and there was plenty of room for growth, with Ford predicting that the performance of the structural heart business would improve in the coming quarters.

MitraClip Mitral Valve Treatment System

Abbott estimates that the cumulative incidence of pre-deployment clip fixation problems rose from 0.51% in 2021 to 0.80% between February and July 2022. The company tracked an increase in post-deployment malfunctions from 0.28% to 0.50% over the same period. In more than 90% of pre-deployment failures and 60% of post-deployment failures of MitraClip, the problem had no consequences for the patient. However, for some patients, there are still consequences, as a rule, this is a recurrence of mitral regurgitation during the procedure.

Abbott warns that a botched MitraClip procedure could potentially lead to consequences such as cardiogenic shock and death in some patients, although the percentage of successful procedures remains unchanged even with increased malfunctions. As a result of the malfunction, there were no cases of immediate transition to open mitral valve surgery, but in 0.53% of malfunctions, disease persistence subsequently led to surgery.

The affected MitraClip devices remain on the market as Abbott works to reduce risk and reduce fault frequency. Having identified the change in the material properties of one of the components as the cause of the problem, the company is working on the release of new batches with updated processes and raw materials. The developers advise doctors to take certain actions to reduce risk if the device needs to be operated.^[1]

2019: Announcement

In mid-July 2019, Abbott Laboratories introduced a new version of the MitraClip device to perform minimally invasive mitral valve repair procedures.

Called the MitraClip G4 (fourth generation), the new device offers an expanded range of clips of different sizes, alternative door grip technology, and a function to integrate with the pressure monitor to assess the patient's condition in real time.

Abbott unveils catheter system for mitral valve operations

First introduced in the US in 2013, the MitraClip catheter system has become an alternative to open heart surgery for mitral valve regurgitation. Over the years, MitraClip has been used in the operation of more than 80,000 patients worldwide. Together with the FreeStyle Libre glucose monitoring device and Alinity blood and plasma screening systems, the MitraClip catheter system is one of Abbott's key long-term growth drivers.

MitraClip was initially approved for the treatment of patients with primary mitral regurgitation. In March 2019, Abbott achieved expanded indications for MitraClip in a broader population of patients with heart failure and secondary mitral regurgitation. MitraClip G4 can help patients with both primary and secondary mitral regurgitation. The device has clips of four sizes, including variants with a wider grip area.

Another innovation is independently controlled clamps, which allow the physician to grip one or both valve flaps during the procedure. The upgraded G4 catheter includes a pressure monitor allowing continuous evaluation of the left atrium during implantation. The monitor confirms a decrease in mitral regurgitation and allows the doctor to find the optimal exposure point.^[2]

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