The customer had already developed a novel coronary stent, but lacked an effective and manufacturable delivery system to allow direct stenting and save valuable procedure time and costs for healthcare providers. The stent’s wire-delivery system, developed by a competitor, failed to pass design validation. So, the client came to Freudenberg Medical Minimally Invasive Solutions, requiring all the elements for a successful OUS approval and launch, including clinical studies, a repeat of design validation, process development and process qualification, in order to expedite the clinical study timeline and gain CE approval.
Our challenge was to quickly and efficiently implement our process that repeatedly leads to successful product launches, instead of attempting to improve the competitor’s previous design that failed to pass design validation. Our team developed a comprehensive balloon-development strategy and redesigned the device, resulting in successfully shipping a of First-In Man clinical product in eight months. With the continuation of a design validation build to support the CE marking, we executed the manufacturing process development and qualification within the next nine months, and were able to successfully launch the product at the Transcatheter Cardiovascular Therapeutics conference. The launch at the conference included a live case using the new system and set up a broader market introduction for our customer.
The product had a successful clinical trial and received its CE marking less than four weeks after submittal. Combining the client’s stent technology with the Freudenberg Medical Minimally Invasive Solutions developed commercially manufacturable delivery system also potentially allows the stent to be implanted via a radial artery approach. This approach greatly magnifies the uniqueness of the technology and potentially enhances patient safety and comfort.
Following the device’s success, the client has continued to work with us on the second-generation device, to be developed for U.S. approval. Our partnership ultimately resulted in a product whose clinical efficacy exceeded that of the initial design. Freudenberg Medical Minimally Invasive Solutions protected and strengthened our customer’s ability to launch and scale products to meet the anticipated market needs. We continue to develop the balance of this client’s portfolio needs, advancing our customer’s business and enhancing patient care.