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The US heart valve device market is large and growing, driven by the continued adoption and launch of THV devices, as well as an aging population. The accumulation of positive clinical trial data is also driving the uptake of THV devices into populations usually treated with surgical devices or were not treated with device intervention. The competitive landscape for the heart valve market continues to shift: small companies with unapproved, innovative devices are acquired by established market players, whereas new competitors and novel types of THV devices are expected to become available in coming years.
This Medtech 360 Report provides comprehensive data and analysis on the current state of the market for heart valve devices in the US across a 10-year period.
In 2018 Boston Scientific entered the US heart valve device market by acquiring Claret Medical and its FDA-approved Sentinel cerebral EPD
How does this influence the competitiveness of Boston Scientific's entrance into the TAVR market in 2019?
What is the expected uptake of cerebral EPD's in the US market?
Positive results from the COAPT trial will result in strong growth for Abbott Laboratories's MitraClip TMVR device.
What additional US patient populations are now accessible by the positive COAPT trial results?
How does this influence the uptake of other TMVR devices that are expected to earn FDA approval over the forecast period?
The market and competitive landscape for the transcatheter mitral valve device market is in flux.
When are TMVI devices expected to enter the US market? Which company is most likely to be first to earn FDA approval?
How will TMVI coexist with TMVR?
How will the development of the transcatheter mitral valve device market affect the development of the future TTVR market?
Tissue heart valves and surgical annuloplasty repair devices face competition from THV devices.
How will the new transcatheter technologies affect the surgical repair and replacement device markets?
What are some strategies that manufacturers have used to mitigate the impact of THV devices on surgical heart valve product lines?
How will the future availability of TTVR devices affect surgical tricuspid repair procedures?
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Erik J. Bracciodieta is a senior analyst within the Cardiovascular Medtech Insights team, specializing in cardiac rhythm management and structural heart closure device markets, as well as medical device pricing and regulations in Japan. Erik holds a Master's degree in Biotechnology from the University of Toronto. Follow Erik on Twitter: @ErikB_DRG.