Success Story
Minimizing Blood Loss
A success story with FlexSeal® Hemostasis Valve
A global medical device company sought to improve its hemostatic introducer used in minimally invasive cardiovascular procedures. The Gen1 valve could not withstand arterial pressure requirements defined in ISO11070, lacked tactile control, and was inefficient in supporting multiple catheter sizes. The new solution needed to optimize sealing, ease of use, and compatibility, while maintaining scalability for global production.
Advancing Next-Generation Delivery
Freudenberg Medical led the redesign of the hemostasis valve, delivering a next-generation introducer to meet high clinical and manufacturing performance standards. The valve features an innovative geometry and material combination using dual-durometer liquid silicone rubber (LSR).
This achieves a “gel-cushion” effect, providing robust sealing with improved tactile feedback.
Our Support
Vertical Integration and Collaboration
A custom-designed 2-shot molding process was implemented, enabling direct bonding between hard and soft components using a single machine. This minimizes production steps, supports tight tolerances, and ensures a scalable solution without specialized equipment.
Design, development, and manufacturing are made possible through vertically integrated capabilities across multiple Freudenberg sites:
- Beverly, Massachusetts: 2-shot LSR molding and material expertise
- Minnetonka, Minnesota: Device design and development
- Jeffersonville, Indiana: Scalable device assembly
- Kaiserslautern, Germany: Silicone molding, tool support and validation
- Aachen, Germany: Hydrophilic coating
Freudenberg Technology Innovation, Weinheim, Germany: Digital modeling, design simulations, and CT analysis
Freudenberg Technology Innovation created a digital twin of the valve and surrounding housing, enabling 20+ virtual design iterations. This eliminated the need for multiple introducer SKUs and ensured compatibility with high-pressure arterial applications.
FlexSeal® Hemostasis Valve is a true team effort. Cross-functional teams from four countries combined expertise in silicone molding, coatings, and catheter design to deliver a device that performs reliably in the most demanding procedures. We’re proud to offer our customers a fully integrated solution they can build on - developed in-house, proven in the lab, and trusted in the field.
Dave Ruder
Director Product Development at Freudenberg Medical
The Result
Improving Patient Outcomes
The FlexSeal® Hemostasis Valve offers strong clinical benefits, including reliable hemostasis across a wide range of catheter sizes and improved safety through reduced risk of air embolism and blood loss. Single-handed operation enhances workflow and tactile control, while the design meets ISO11070 arterial pressure standards for high-pressure use, eliminating the need to switch introducers mid-procedure.
Manufacturing efficiency is achieved through an innovative 2-shot molding process on a single machine with cold runner technology, minimizing waste and enabling scalable production. A single device now supports multiple use cases, reducing inventory needs and procedural waste. The use of durable materials extends shelf life and helps hospitals reduce scrap and streamline operations.
