--- title: "Structural Heart, Definition | MedTech Terms" description: "Transcatheter therapies for valvular and structural heart disease. 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This pathway demands extensive clinical evidence of safety and effectiveness." } }, { "@type": "Question", "name": "How does the EU MDR impact structural heart device manufacturers?", "acceptedAnswer": { "@type": "Answer", "text": "The EU MDR mandates stricter clinical evidence requirements, enhanced post-market surveillance, and re-certification of Notified Bodies, leading to longer and more complex conformity assessment processes for structural heart devices." } }, { "@type": "Question", "name": "Are software components in structural heart devices subject to special regulations?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, software as a medical device (SaMD) or software components within structural heart devices must comply with specific regulations and guidance, including FDA guidances on medical device software and considerations for cybersecurity detailed in IMDRF SaMD guidance." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Market Segments](/terms?cat=Market%20Segments) 6. / 7. Structural Heart [All terms](/terms) Market Segments [Strategic Landscape](/ecosystems/strategic-landscape) # Structural Heart Transcatheter therapies for valvular and structural heart disease. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition 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. What the regulation says Structural heart devices, encompassing technologies like transcatheter aortic valve replacement (TAVR) and devices for repairing or replacing other cardiac valves or closing structural defects, are subject to stringent regulatory oversight by bodies such as the FDA in the United States and under the [EU Medical Device Regulation](/terms/mdr) (EU [MDR](/terms/mdr-reporting)) in Europe. Manufacturers must demonstrate safety and effectiveness through robust clinical trials, adhering to requirements outlined in documents like 21 CFR Part 812 for investigational device exemptions and EU MDR Annex I for [general safety and performance requirements](/terms/gspr). Specific guidance documents may exist for particular device types within this segment, addressing pre-market approval ( [PMA](/terms/pma)) or conformity assessment pathways. ## What this means in practice 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. ## Examples - A company developing a new transcatheter mitral valve replacement (TMVR) device conducts a pivotal clinical trial to gather safety and efficacy data for its PMA submission to the FDA. - A manufacturer of an atrial septal defect (ASD) closure device updates its technical documentation to align with the new general safety and performance requirements of the EU MDR, undergoing a conformity assessment with a Notified Body. - Prior to market release, a structural heart device with remote monitoring capabilities undergoes a thorough cybersecurity vulnerability assessment to comply with FDA pre-market submission requirements for medical device cybersecurity. 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. ## Frequently asked questions What is the primary regulatory pathway for novel structural heart devices in the US? Most novel structural heart devices require a [Premarket Approval](/terms/pma) (PMA) application to the FDA, due to their high-risk classification. This pathway demands extensive clinical evidence of safety and effectiveness. How does the EU MDR impact structural heart device manufacturers? Are software components in structural heart devices subject to special regulations? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Market Segments Cardiovascular Devices Devices for diagnosing, monitoring, or treating cardiovascular disease. ](/terms/cardiovascular)[ Reimbursement New Technology Add-On Payment(NTAP) Supplemental Medicare payment for inpatient use of qualifying new technologies. ](/terms/ntap) ### More in Market Segments · Same category [ Market Segments Aesthetic & Energy-Based Devices Lasers, RF, ultrasound, cryolipolysis, and IPL systems used for medical and cosmetic indications, body contouring, hair removal, skin tightening, vascular lesions. ](/terms/aesthetics-energy-devices)[ Market Segments AI Imaging Software Software that analyzes medical images to triage, detect, or quantify disease. ](/terms/ai-imaging)[ Market Segments Cardiac Rhythm Management(CRM) Implantable and external devices that monitor and treat cardiac arrhythmias, pacemakers, ICDs, CRT devices, and insertable cardiac monitors. ](/terms/cardiac-rhythm-management)[ Market Segments Clinical Laboratory Improvement Amendments(CLIA) U.S. federal standards that govern clinical laboratory testing. ](/terms/clia) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Strategic Landscape](/ecosystems/strategic-landscape) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ACC· 1 AdvaMed· 1 MedTech Europe· 1 1. [1 ACC structural heart hub Verified ACC · acc.org ](https://www.acc.org/) 2. [2 AdvaMed - Industry Reports Verified AdvaMed · advamed.org ](https://www.advamed.org/our-work/) 3. [3 MedTech Europe - Facts & Figures Verified MedTech Europe · medtecheurope.org ](https://www.medtecheurope.org/datahub/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Building a connected device in this segment? Blue Goat Cyber specializes in MedTech cybersecurity across imaging, cardiac, IVD, surgical, and other connected segments. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Market Segments Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=structural-heart) Learn in 60 seconds Card Lesson Quiz Transcatheter therapies for valvular and structural heart disease. - · 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. Remember this Watch out: 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. Related terms - [Cardiovascular Devices ](/terms/cardiovascular) - [New Technology Add-On Payment(NTAP) ](/terms/ntap) You may also need Auto-suggested from Market Segments and shared keywords. - [Electrophysiology(EP) ](/terms/electrophysiology) - [Cardiac Rhythm Management(CRM) ](/terms/cardiac-rhythm-management) - [Renal Care Devices ](/terms/renal-care-devices) - [AI Imaging Software ](/terms/ai-imaging) - [Digital Therapeutic(DTx) ](/terms/samd-dtx) - [Digital Therapeutics(DTx) ](/terms/digital-therapeutics) [All Market Segments terms](/terms?cat=Market%20Segments) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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