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Cathlete Plus TAVI Prosthesis Delivery System

Jenavalve Technology

Medical: Optimizing Usability and Workflow

This redesigned loading system simplifies a challenging set-up process, supporting minimally invasive heart surgery.

JenaValve Technology produces a transcatheter aortic valve implantation (TAVI) system that makes heart valve repair less invasive with fewer complications. With the only TAVI system worldwide with CE approval for the treatment of aortic valve stenosis and aortic valve insufficiency, JenaValve is poised to be a leader in a space now dominated by giants like Edwards Life Sciences and Medtronic.

Usability was a roadblock to the company’s upward ascent. The existing proof-of-concept system provided a poor user experience. It was difficult to set up and deploy, requiring 30 separate steps and, at times, three hands from two users.

Karten Design set out to simplify the procedure. By observing surgeries, we determined that the biggest challenge in the process was collapsing and loading the prosthesis onto a catheter for insertion into the patient. We returned to the studio and performed a detailed, step-by-step analysis of the loading procedure, mapping the difficulty of motion, force, and cognition. Visually quantifying the levels of force and cognition required throughout the procedure allowed us to see moments where physical and mental stressors converged, creating pain points in the user experience.

With a clear roadmap for improving usability, Karten Design employed a “Fail Forward Fast” strategy to quickly evaluate and refine solutions. The design team developed a volume of ideas via iterative CAD models, and quickly vetted the ideas with rapid prototypes, tested by our team and JenaValve’s, to hone in on the most successful solutions.

Our improvements create a more streamlined, intuitive experience. The new loading procedure reduces 30 steps to 27. We redesigned the loading system so that it automatically compresses both ends of the prosthesis to the correct desired diameter, without requiring manual effort or additional tools. The design also makes each individual step simpler. For example, where the proof of concept required a series of complex actions—gripping, squeezing, pushing, and turning all in one step—the redesigned mechanism snaps into place with a single motion.

Our new design minimizes the amount of training required, using color and material to cue action: blue parts signify user interaction areas, while white parts signify no physical action is required. With fewer, more lightweight parts and pieces, the new system is easier to assemble and requires only a single user to operate. Karten Design also introduced innovations to improve the user’s confidence with the procedure, such as transparent areas that allow users to maintain a visual of the prosthesis as it loads onto the catheter.

JenaValve has raised $26.5 million in financing since its system’s redesign. The money will fund clinical studies in Europe and a feasibility trial that will help determine FDA approval in the U.S.

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