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Given the FDA approvals only happened in Q3 2019 and the CE mark approval only happened in Q4 2019, their impact on the respective US and European markets is unknown. However, assuming that they will lead to an increased use of TAVI (and an increased use of TAVI in low-risk patients) would be reasonable. TAVI is already a growing market. The BIBA MedTech Insights TAVI Monitor, which tracks data on a quarterly basis, shows that the number of TAVI implants in Western Europe increased from 13,677 in Q3 2018 to 16,306 in Q3 2019—a 19.2% increase (see Figure 1). Therefore, if the TAVI market does continue to grow, the key questions are whether the rate at which it is growing will increase and how much is attributable to low-risk patients.

The proportion of TAVI procedures performed in low-risk patients also increased between Q3 2018 and Q3 2019: from 4.6% to 5.2%. Going forward, again, (assuming this growth continues) a question is whether the rate at which this proportion is growing will increase.

Another unknown is how getting the CE mark for low-risk will affect Edwards Lifesciences’ market share. The company is already the market leader and is likely to remain in this position, so the question is whether its share of the market (43% in Q3 2019) will increase. This is more difficult to predict given Medtronic may soon receive CE mark approval for CoreValve to be used in low-risk patients (like Edwards, Medtronic has positive data for low-risk patients) and other valves may come onto the market.

The end.

Source. CardiovascularNews

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