Minnesota USA 

Minnetonka

Concept and Product Development, Human Clinical Build Support 

Minnetonka operates as the Balloon Development and Catheter Development Center of Excellence, focusing on concept and product development for minimally invasive surgical devices.

The site supports pre-production assembly, human clinical build support, and product lifecycle management. Rapid prototyping and a model shop are integral for design iteration and development efficiency. Minnetonka functions under ISO Class 8 cleanroom conditions, with certifications in ISO 13485, 14001, and 45001, underscoring its commitment to quality and environmental standards.

The site’s capabilities enable the development of advanced balloon catheters and related devices, facilitating seamless transitions from concept through clinical trials to production readiness.