Structural heart refers to minimally-invasive, catheter-based therapies that repair or replace cardiac valves and close structural defects - TAVR, transcatheter mitral and tricuspid repair/replacement, left atrial appendage closure (LAAC), and PFO/ASD closure. Most of these are Class III devices that need PMA approval, and coverage often relies on national coverage determinations with registry requirements. Heart team evaluation and operator training are central to adoption.

Why it matters

TAVR (Edwards SAPIEN, Medtronic CoreValve) transformed aortic stenosis treatment. Mitral and tricuspid programs are the next major growth drivers. Reimbursement is generally favorable through MS-DRGs and dedicated NTAPs early in launch.

Common pitfalls

•A common pitfall is underestimating the complexity of clinical trial design and execution required for novel structural heart devices, leading to significant delays in market access.
•Failing to adequately address post-market surveillance requirements, such as those under 21 CFR Part 822 for postmarket surveillance studies or EU MDR Article 83 for post-market surveillance systems, can result in regulatory actions.
•Inadequate cybersecurity considerations for connected structural heart devices can lead to vulnerabilities, posing risks to patient safety and data integrity, and potentially violating regulations like those concerning medical device security.
•Manufacturers sometimes overlook the need for comprehensive risk management, as mandated by standards like ISO 14971:2019, specifically addressing the unique risks associated with implantable and life-sustaining structural heart devices.
•Another mistake is not anticipating the evolving reimbursement landscape and its impact on market adoption, even with favorable initial coverage.

Sources

ACC structural heart hub · ACC
AdvaMed - Industry Reports · AdvaMed
MedTech Europe - Facts & Figures · MedTech Europe
FDA Division of Circulatory Support, Structural and Vascular Devices · FDA

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Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
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