Our Structural Heart Development Capabilities
Successful structural heart medical device engineering requires a deep understanding of large-profile, highly functional implants interact with complex tracking and deployment systems. Our core capabilities span the entire development lifecycle:
Concept Development and Feasibility
We translate clinical goals into practical engineering architecture. Our team evaluates early-stage concepts for tracking mechanics, push-pull dynamics, and implant retention, establishing a clear technical baseline before progressing to detailed design and development.
Catheter-Based Delivery System Design
A structural heart implant is only as good as its delivery platform. We excel in structural heart catheter development and structural heart delivery system development, engineering multi-lumen shafts, steerable mechanisms, and handle architectures that provide physicians with precise positioning and reliable deployment control.
Finite Element Analysis (FEA)
Structural heart implants and delivery components endure significant cyclic fatigue and mechanical stress. We utilize advanced FEA modeling to simulate stress, strain, radial force, and fatigue life. This digital validation improves optimization before physical parts are built.
Material Selection and Biocompatibility
Navigating the material demands of transcatheter device development requires specialized expertise. We design using advanced materials, balancing optimal trackability with strict biocompatibility, radiopacity, and thromboresistance requirements.
Prototyping and Design Iteration
Accelerating development timelines requires fast physical feedback. Our in-house lab allows us to rapidly prototype complex catheter handles, deflection mechanisms, and distal configurations, giving your engineering team tactile and visual proof-of-concept models without delay.
Bench, Simulated-Use, and V&V Support
We subject delivery platforms and implants to rigorous verification testing. Our team builds models to simulate tortuous vascular paths, evaluating trackability, deployment forces, particulate generation, and recapture capabilities to build a robust data package for regulatory submission.
Controlled Builds and Low-Volume Manufacturing
Consistency is critical when preparing for animal studies or clinical trials. We provide controlled build services within our quality management framework, developing repeatable assembly processes, custom fixtures, and inspection methods that eliminate build variability all within our class 7 & 8 cleanroom.
Contact Rev.1 Engineering for Structural Heart Device Development Services
Rev.1 Engineering Structural Heart Development Services
Rev.1 Engineering specializes in structural heart device development, providing the technical expertise needed to build sophisticated implants and their accompanying catheter-based delivery systems. We partner with startups and established OEMs to engineer systems for valve repair, valve replacement, left atrial appendage closure, septal occlusion, and more.
Our cross-functional team delivers the precision design, rapid prototyping, and controlled build support necessary to navigate early feasibility, animal studies, and regulatory validation.
Engineering Challenges We Solve
Structural heart procedures often have thin margins for error. Rev.1 Engineering resolves the critical technical hurdles that frequently stall structural heart device design:
Achieving Controlled Delivery Through Challenging Vascular Access
Navigating large-profile delivery systems through tortuous femoral or transeptal access routes risks vessel trauma or kinking. We balance shaft support and flexibility to ensure smooth tracking without sacrificing pushability.
Balancing Shaft Support, Steerability, and Torque Response
Catheters must transmit user inputs perfectly from the handle to the distal tip. We optimize braid density, liner materials, and pull-wire configurations so the system responds predictably during multi-axis deflection.
Supporting Precise Positioning, Recapture, and Deployment Control
Implants must be placed with absolute accuracy. To ensure this, we engineer internal tensioning systems and release mechanisms that provide smooth, jump-free deployment and reliable recapture if repositioning is required.
Designing for Imaging-Guided Workflows
Physicians rely heavily on fluoroscopy and echocardiography during structural heart cases. We integrate radiopaque markers, echocardiogenic materials, and ergonomic handles to fit seamlessly into the physician’s operating environment.
Reducing Build Variability for Pilot and V&V Builds
Hand-building complex multi-lumen catheters often introduces subtle variations that skew test data. Our disciplined manufacturing transition stabilizes assembly workflows early, ensuring your V&V and animal study builds are highly repeatable.
Why Partner with Rev. Engineering?
When developing a structural heart platform, you need an engineering partner that understands how the delivery system, handle, and implant function as a unified system.
The Rev.1 Advantage
✔ Specialization in complex catheter delivery systems.
✔ Integrated FEA modeling and material science expertise.
✔ Rapid, hands-on prototyping and controlled clinical build support.
✔ Focus on manufacturability.
✔ Collaborative team acting as a direct extension of your internal R&D.
Rev.1 Engineering has the team and the infrastructure to move your project forward safely and efficiently.
Developing a complex structural heart platform requires a partner with deep interventional experience, precision engineering tools, and a clear understanding of the clinical environment.
Whether you need to optimize a deflection handle, run FEA on a new design, or produce controlled builds for your next study, our team is ready to execute.
Start Your Structural Heart Development Project
Whether you need to optimize a deflection handle, run FEA on a new design, or produce controlled builds for your next study, our team is ready to execute.
Contact Rev.1 Engineering Today to schedule a consultation, discuss your transcatheter design goals, or plan your upcoming prototyping and validation phase.