Defining the Broader CHD Conduit Market
Congenital Heart Disease (CHD) refers to a range of structural problems with the heart that are present at birth. It is the most common type of birth defect. In many complex CHD repairs, surgeons use conduits—specialized tubes—to create or reconstruct pathways for blood flow.
The overall "CHD conduit market" encompasses various devices used in these procedures. The pediatric pulmonary valve market is a critical subsegment, specifically addressing defects of the Right Ventricular Outflow Tract (RVOT), the pathway that controls blood flow from the heart to the lungs.
Market Subsegment View
Illustrative breakdown of the pediatric CHD conduit market.
Key Statistics (United States)
Born with CHD Annually
~40,000
Born with RVOT Lesions Annually
~6,200
Children Living with CHD
~1 Million
Addressable Annual Procedures
~3,800
References:
- Mai CT, et al. Birth Defects Research. (2019). [Source for RVOT Lesion cohort size]
- Hoffman JL, Kaplan S. J Am Coll Cardiol. (2002). [Source for overall CHD incidence]
- Gilboa SM, et al. Circulation. (2016). [Source for CHD prevalence]
- Procedure volume is a derived estimate based on clinical registry data and intervention rates.
Breaking Down the ~6,200 Annual RVOT Cohort
The ~40,000 annual CHD births represent the total patient pool. The target market is a specific ~16% subset of these births involving lesions of the pulmonary valve or the Right Ventricular Outflow Tract (RVOT). This cohort is comprised of several distinct, separately-coded defects.
Key Insight
This isn't one disease; it's a clinical cohort. These distinct defects all require intervention in the same anatomical location (the RVOT), creating a unified market for pulmonary valve technologies.
~3,600 / year
Pulmonary Atresia/Stenosis
The pulmonary valve itself is malformed, being either completely sealed (atresia) or too narrow (stenosis).
~1,700 / year
Tetralogy of Fallot
A complex condition of four related defects, which critically includes pulmonary stenosis.
~630 / year
Double-Outlet Right Ventricle
Both the aorta and pulmonary artery connect to the right ventricle, often requiring RVOT reconstruction.
~250 / year
Truncus Arteriosus
A single large blood vessel leaves the heart; surgical repair involves creating a new RV-to-PA conduit.
Source: Defect-specific birth prevalence from Mai CT, et al. (2019), based on NBDPN 2010–2014 data, applied to a ~3.7M U.S. births baseline.
Market Sizing Methodology
A credible market model requires a defensible, bottom-up approach. Our methodology moves from broad epidemiological data to specific, addressable procedure volumes, ensuring a transparent data lineage from primary sources to final revenue projections.
Epidemiological Foundation
Start with peer-reviewed data on disease incidence (e.g., CDC, Mai et al.) to establish the total patient population (~6,200 births/yr).
Procedure Volume Analysis
Refine the patient pool by analyzing clinical registries (e.g., STS) for actual intervention rates, yielding the addressable market (~3,800 procedures/yr).
Revenue Projection
Calculate market size by applying average selling prices (ASPs) to the addressable procedure volume.
U.S. Pediatric Pulmonary Valve Market Model
This interactive model demonstrates the bottom-up market sizing. Adjust the sliders to see how changes in annual procedures and average selling price (ASP) affect the total addressable market (TAM).
Total Addressable Market (TAM)
$133.0M
Competitive Landscape & Incumbents
The market is a concentrated duopoly between Medtronic and Edwards Lifesciences, who leverage established platforms. Autus Valve aims to disrupt this by addressing the unmet need of somatic growth in the youngest patients.
Autus Valve
Disruptor / New Entrant
Key Product: Growth-accommodating surgical valve
Strategy: Target the youngest pediatric patients (18 mos - 16 yrs) with a surgical valve that can be expanded via transcatheter dilation as the child grows, aiming to reduce lifetime reoperations.
Medtronic
Market Leader
Key Products: Melody™ & Harmony™ TPVs
Strategy: Purpose-built pulmonary valves for different anatomies. Melody for existing conduits; Harmony for native RVOTs, covering a broad older patient segment.
Edwards Lifesciences
Primary Challenger
Key Products: SAPIEN™ Valve + Alterra™ Stent
Strategy: Leverage the dominant SAPIEN platform. The Alterra pre-stent remodels the RVOT to fit a SAPIEN valve, expanding its use.
Abbott
Niche & Surgical Player
Key Products: Amplatzer™ Plugs, Surgical Valves
Strategy: Peripheral in the TPV space; competes with surgical valves and structural heart occluders in adjunctive procedures.
Detailed Comparison: Patient Population & Indications
Autus Valve
Indicated for young pediatric surgical PVR (18 mos - 16 yrs). Targets a critical care gap in the youngest patients requiring a valve that can grow with them.
Medtronic Melody™ TPV
For patients with existing dysfunctional RVOT conduits or bioprosthetic valves (≥16 mm). Not for native RVOTs.
Medtronic Harmony™ TPV
For patients with native or repaired RVOTs suffering from severe pulmonary regurgitation. Serves a large segment with anatomy unsuitable for balloon-expandable valves.
Detailed Comparison: Procedural Access & Delivery
Autus Valve
Initial surgical implant bypasses vascular access size limitations in small children. Subsequent interventions are minimally invasive transcatheter dilations.
Medtronic Melody™ TPV
Requires large 22 Fr venous access, a primary factor limiting its use in small children whose femoral veins cannot accommodate the sheath.
Medtronic Harmony™ TPV
Requires very large ~25 Fr venous access, similarly restricting its application in the youngest pediatric patients.
Detailed Comparison: Growth Accommodation
Autus Valve: Yes
Core design principle. The valve can be serially expanded via balloon dilation from ~12.7 mm up to 22 mm to match the patient's somatic growth into adulthood.
Medtronic Melody™ TPV: No
The device has a fixed frame size and cannot be expanded beyond its deployment diameter to accommodate patient growth, necessitating future reoperations.
Medtronic Harmony™ TPV: No
The self-expanding frame is also of a fixed size and does not possess any capacity for growth, leading to the same limitation.
Investment Thesis: Key Takeaways
Focused, High-Value Market
The market is not multi-billion dollar, but a focused $120-150M segment. Success hinges on capturing premium value, not unrealistic share of an inflated estimate.
Unmet Clinical Need
Existing devices are not designed for growth, leading to repeat surgeries. A growth-accommodating valve would be a paradigm shift, commanding premium pricing.
Clear Competitive Differentiation
Autus Valve's ability to accommodate growth and its surgical access for small children directly addresses the key limitations of incumbent transcatheter devices.
Achievable Exit Potential
Capturing 15-20% market share could yield $20-30M in annual revenue, supporting a $150-250M exit valuation based on typical medtech multiples.