[Amsterdam, June 4^th, 2025] – According to a new study by Clearview Market Insights (CVMI), the global Transcatheter Pulmonary Valve (TPV) market will soar from USD 880 million in 2024 to USD 2.05 billion by 2031, registering a CAGR of 12.8 %.

“Transcatheter valve therapy has moved beyond the aortic position,” said Dr. Marieke Janssen, Structural Heart Analyst at CVMI. “With self-expanding platforms now approved for native outflow tracts, TPV is poised for the next wave of growth.”

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Growth Catalysts

• Rising adult CHD population needing redo interventions.
• Avoidance of repeat sternotomy reducing morbidity and cost.
• Device portfolio expansion – larger diameters and repositionable frames.
• Robust reimbursement across U.S., EU, and Japan.
• Technological synergy with 3D imaging and embolic protection.

Segmentation Snapshot (2024)

By Valve Type           Share

• Self Expanding XX%
• Balloon Expandable XX%

By Patient Group      Share

• Surgically Placed Conduits XX%
• Native RVOT XX%

By End User  Share

• Adult Congenital Centers 51 %
• Pediatric Cardiology Hospitals XX%

• Academic Hospitals    XX%

Self-expanding valves lead the market and are projected to achieve a 60% share by 2028 as native RVOT devices gain traction. The segment for surgically placed conduits currently dominates, but the native RVOT segment is expected to grow at a CAGR exceeding 15%, highlighting an unmet need in larger outflow tracts.

Regional Momentum

• North America – 41 % share; Medicare coverage for Harmony; ACH network expansion.
• Europe – XX%; CE‑MDR approvals broaden valve choice; Germany tops implant volume.
• Asia‑Pacific – XX%; China’s national CHD registry drives referrals; Japan expands specialist centers.
• LATAM & MEA –XX% combined; Brazil’s SUS pilot and UAE Heart Center pave adoption.

Competitive Highlights

Medtronic retains leadership with its Melody and Harmony portfolios, now covering diameters of 22–30 mm. Edwards Lifesciences increases competitive pressure with larger-diameter trials of the SAPIEN Pulmonic. Venus MedTech has secured a CE mark for its VenusP Valve, addressing the native RVOT gap, while JenaValve and Meril Life advance their pipeline technologies.

Innovation Trends

• Polymeric & tissue-engineered leaflets for extended durability.
• Steerable delivery catheters reduce fluoroscopy by 25 %.
• AI planning software auto-segments RVOT and simulates valve fit.
• Embolic protection devices adapted from TAVI enter TPV trials.
• Hybrid OR–cath lab integration enables complex redo cases.

Looking Ahead to 2031

Year    Milestone

2026 - Native RVOT valves represent 45 % of EU implants

2027 - First polymer leaflet TPV gains CE mark

2028 - Global TPV annual implants exceed 25,000

2029 - U.S. FDA approves larger diameter SAPIEN Pulmonic 35 mm

2030 - Endocarditis rates decline 30 % with antibiotic eluting stents

2031 - >70 % of RVOT re interventions managed transcatheterly worldwide

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About Clearview Market Insights

Clearview Market Insights delivers data‑driven foresight across structural heart and congenital cardiology markets.Media contact:

Bhavani K
Marketing and Sales Head
ClearView Market Insights
Mail: sales@clearviewmarketinsights.com
Phone: +1 917-993-7369