Company Profile
VDyne is a US-based manufacturer of structural heart devices, headquartered in Maple Grove, Minnesota, USA. Founded in 2017, the company operates as an independent, privately-held entity backed by Jean Boulle Group, serving interventional cardiologists and cardiac surgeons in the structural heart market.
Core Products ＆ Technologies
Transcatheter Tricuspid Valve Replacement Systems
• VDyne TTVR System: Investigational dual-frame nitinol prosthesis housing a 30-mm porcine trileaflet valve, designed to preserve the asymmetric morphology of the tricuspid annulus; accommodates annular perimeters up to 180 mm (diameters 42 to 56 mm) with minimal oversizing
• VDyne Delivery System: 28-Fr femoral delivery catheter enabling full recapture and repositioning after intracardiac deployment; features anchoring independent of native leaflet visualization
Market Position ＆ Certifications
VDyne holds a pioneering position in the global transcatheter tricuspid valve replacement market, competing with Edwards Lifesciences (EVOQUE) and Medtronic (Intrepid) in TTVR. Key strengths include:
• Asymmetric frame design: Preserves right ventricular shape and minimizes annular oversizing
• Regulatory progress: FDA Breakthrough Device Designation previously granted; FDA IDE G210172 approved in April 2026 for the TRIVITA1 pivotal trial; CMS IDE study approval granted April 2026
• Clinical evidence: First-in-human use in November 2023; 100+ successful procedures across 15 countries; VISTA early feasibility study data presented at EuroPCR 2025
• Global development: Advancing TRIVITA1 pivotal trial and registrational studies to support CE Marking
Corporate Timeline
2017 — Founded in Maple Grove, MN to develop transcatheter valve replacement technologies
2018 — Closed $5.2M Series B financing
2020 — Closed Series C1 financing and received grant funding
2022 — Closed $47M later-stage financing to accelerate clinical development
2023 — First-in-human use of the VDyne TTVR system completed in November
2025 — VISTA-US and VISTA-Global early feasibility study data presented at EuroPCR
2026 — Mike Buck appointed Chairman and CEO in March; FDA IDE G210172 approved in April for TRIVITA1 pivotal trial; CMS IDE study approval granted in April
Target Markets ＆ Applications
• Severe tricuspid regurgitation: TTVR system for symptomatic patients at high surgical risk
• Functional tricuspid regurgitation: Valve replacement for annular dilatation with severe coaptation defect
• Combined valve disease: Adjunct therapy for patients with concurrent mitral and tricuspid valve disease
Contact Information
Global Headquarters
Address: Maple Grove, Minnesota, USA
Parent Company
VDyne operates as an independent, privately-held entity backed by
Jean Boulle Group, with no publicly traded stock.
Website: vdyne.com
Investor Relations: Private company; contact investor@vdyne.com
