With transcatheter mitral valve repair (TMVR) heart surgery being one of the fastest-growing fields in the realm of heart surgery at the moment—leading data and analytics company GlobalData expects the market to more than double in size to $3.4bn by 2030—it would appear to be plain sailing for Abbott as its TMVR therapy MitraClip is the current leader of the pack. However, the US Food and Drug Administration’s (FDA) recent warning about MitraClip clip lock malfunctions may mean physicians will turn elsewhere.

According to modelling based on GlobalData’s latest report, ‘Transcatheter Mitral Valve Repair Market Size, 2015-2030’, the malfunctions, reported by the FDA to occur in 1.3% of MitraClip procedures, affect around 600 people worldwide.

James Spencer, Data Scientist at GlobalData, comments: “This recent spate of malfunctions is a new development resulting from a change in material in one of the components of the MitraClip device. Abbott is not issuing a recall for the current products, instead opting to inform physicians of the issue and how to work around it. This lackadaisical approach to fix structural issues with an incredibly expensive device may shake the faith of physicians and cause them to look elsewhere.”

GlobalData notes that the malfunctions can result in relapse of the conditions as the implant fails to fulfil its purpose. In worst-case scenarios, this can result in the patient needing to undergo surgery to both remove the implant and correct the surgical pathology, potentially doubling the cost of treatment. Untreated, this could result in arrhythmia, edema and eventually escalate into life threatening conditions such as heart attacks or strokes.

Abbott, as a large multinational and early entrant to the TMVR space, currently sits comfortably at the head of the TMVR market, with the company estimated to have a 99% market share.

Spencer adds: “Currently, there are several competitors in the TMVR market such as Cardiac Dimensions, NeoChord, and, most significantly, Edwards Lifesciences Corp with its Pascal device. If these other companies can showcase the relative efficacy and safety of their products, they may win market share in a niche that is set to explode in growth in the coming years.”