Structural Heart Delivery Systems
Designing and Manufacturing Precision Delivery Systems for Next-Generation Structural Heart Therapies.
Structural heart procedures demand exceptional precision, with delivery systems that must navigate a constantly moving anatomy while giving clinicians accurate, repeatable control during implant deployment. Arterex specializes in the user interface of these delivery systems, integrating usability engineering with industrial design and mechanical engineering to create intuitive, reliable handles and mechanisms trusted by clinicians. Combined with vertically integrated manufacturing, this expertise helps customers bring innovative structural heart therapies to market with confidence.
Areas of Expertise
- Heart Valve Delivery Systems
- Aortic Delivery Systems
- High-Pressure Valve Delivery Systems
- Minimally Invasive Delivery Systems
- Delivery System User Interface Design
- Precision Components and Sub-Assemblies
The Delivery System Defines the Procedure
As structural heart therapies reach lower-risk patient populations, the performance demands placed on delivery systems continue to rise, because the system must hold position within a highly dynamic anatomical environment while giving the clinician accurate and repeatable control over deployment.
The central engineering challenge lies in reconciling high operating forces with precise implant placement, since a system that resolves that tension poorly becomes physically demanding to operate at exactly the moment when accuracy matters most.
Our approach begins at the user interface, where we study how clinicians work and then engineer mechanisms and handles around that reality, reducing the input force required while improving deployment accuracy and preserving full control of the device.
Developing these systems also requires minimizing use error and complying with usability standards such as IEC 62366, so human factors and usability engineering guide our work from the earliest stages, identifying and resolving challenges early to deliver safer, more reliable devices, faster approvals, and intuitive, user-centered designs.
Case Study: Avance Heart Valve Delivery System
Background
A changing patient demographic driven by lower-risk cohorts has created the need for innovation in the structural heart space, where implanting a device through a delivery system requires precise and controlled placement within a highly dynamic anatomical environment. Existing systems placed excessive physical demand on the clinician while allowing only limited deployment accuracy.
Our Approach
The Avance™ Heart Valve Delivery System was developed around an innovative handle architecture featuring a dual-speed actuation mechanism. This design optimizes clinician input, enabling precise device control while reducing the force required during deployment.
Results
- The initial phase of deployment provides a 1:1 response, allowing the clinician to position and partially deploy the device with precision at the intended anatomical target.
- The second phase of deployment incorporates a faster travel, enabling efficient full deployment with minimal impact on patient hemodynamics.
- An engineered internal drive mechanism reduces delivery system length, opening the potential for streamlined workflows and single-user procedures in structural heart interventions.
The result is a delivery system that improves deployment accuracy, reduces clinician effort, and supports better procedural outcomes.
Design and Development in Ireland
Arterex’s Synecco facility in Ireland serves as our European Center of Excellence for structural heart and minimally invasive delivery systems. From early-stage research through commercialization, our team partners with customers to transform innovative concepts into manufacturable products.
Capabilities
- Concept Development and Industrial Design
- Brand Identity Through Product Design
- Human Factors and Usability Engineering
- Mechanical, Electrical, and Software Engineering
- Rapid Prototyping and Design Verification
- Design for Manufacturing (DFM) and Design for Assembly (DFA)
- Finite Element Analysis (FEA) for Mechanism and Material Optimization
Our multidisciplinary teams bring together clinicians, industrial designers, usability specialists, product engineers, and manufacturing experts from the beginning of every program. This collaborative approach ensures that usability, performance, manufacturability, and scalability are considered simultaneously, accelerating development and reducing risk as products move toward commercialization.
We create purposeful prototypes through strategic, traceable, and iterative cycles that capture insights, test assumptions, and refine concepts, reducing risk and accelerating progress toward safe, reliable performance. Our Brand Identity Through Product Design (BIPD) service goes beyond meeting product requirements, capturing each customer’s brand essence in a distinctive design language that sets them apart in the market.
Structural Heart Therapies and Specialized Solutions
We support a broad range of structural heart therapies, including valve repair and replacement systems such as TMVR (mitral), TTVR (tricuspid), TAVR (aortic), and valve-in-valve (VIV), as well as ventricular assist and left atrial appendage occlusion (LAAO) therapies.
Our expertise also extends beyond the user interface to specialized solutions, including valve implant loading (crimping and funneling), vascular access, catheter integration, vessel closure systems, hemostasis maintenance, and flushing solutions, along with full device builds that meet each program’s needs.
From Precision Components to Finished Assemblies
Extensive polymer engineering experience underpins robust and repeatable function at every level of the build, extending from individual precision components through to complete sub-assemblies.
Our Synecco operations run 32 molding machines across 52,000 square feet, including an ISO Class 8 cleanroom with the option to upgrade to Class 7 alongside a 22,000 square foot controlled non-cleanroom environment. Injection molding, blow molding, cleanroom assembly, and automated production lines operate together with an in-house metrology laboratory and tool maintenance workshop, all supported by dedicated project, process, tooling, validation, and quality engineers.
Vertically Integrated Component Manufacturing
The performance of a delivery system depends entirely on the components inside it, which is why Arterex manufactures those components across its own network rather than coordinating outside suppliers, removing the handoffs that add cost and lead time to Class II and Class III programs.
- Nitinol, titanium, and stainless steel fabrication
- Micro and circumferential laser welding
- Wire EDM and laser cutting
- Single and multi-lumen tubing extrusion
- Precision injection molding and micromolding
- Insert and overmolding
- Cleanroom assembly and joining
- Sterile barrier packaging, labeling, and sterilization
Sixteen facilities across four continents, more than 225 engineers, and more than 2,300 employees support programs from prototype through pilot and clinical builds and into commercial manufacturing, without requiring a change of partner at any stage.
Quality and Certification
Arterex operates under ISO 13485:2016 and ISO 14001 certification, maintains GMP and GDP compliance, and runs ISO Class 7 and Class 8 cleanroom environments under a single integrated quality system that is applied consistently across every site worldwide.
READY TO PARTNER?
A design challenge should never be allowed to compromise a procedure, so bring us your delivery system problem and our team will work through it with you.