Coronary Stent Delivery System Case Study

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 MedVenture, 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.