JenaValve Appoints Dave Haan as Vice President of Clinical Affairs

JenaValve Technology, Inc., based in Irvine, California, has appointed Dave Haan as Vice President of Clinical Affairs. Haan will oversee the company’s clinical strategy, including the ARTIST randomized controlled trial and the JENA-VAD Registry, as JenaValve expands commercially following FDA approval of its Trilogy Transcatheter Heart Valve (THV) System for symptomatic severe aortic regurgitation (ssAR). Haan joins JenaValve with over 25 years of experience in medical devices, specializing in interventional therapies, regulatory approvals, and global clinical programs. His prior roles include Vice President of Global Clinical Affairs at Danaher’s Beckman Coulter Diagnostics, where he secured over 50 regulatory approvals across the FDA, EU, and NMPA. Before that, he led clinical and product development at Stryker Neurovascular, driving FDA IDE and PMA approvals through large-scale trials. The Trilogy THV System is the first U.S.-approved transcatheter valve for native, symptomatic severe aortic regurgitation in high-risk patients. Unlike conventional TAVR valves, it uses three proprietary radiopaque locators to anchor directly to the aortic leaflets, ensuring stable implantation even without annular calcification. The system received CE Mark in 2021 and has been used in over 1,200 commercial procedures in Europe. Duane Pinto, JenaValve’s Chief Medical Officer, emphasized Haan’s strategic vision as critical to JenaValve’s growth. Haan expressed excitement about leading evidence generation for the Trilogy System, including the ARTIST trial, to expand treatment access for patients with aortic regurgitation. His appointment aligns with JenaValve’s goal of advancing transcatheter aortic valve replacement (TAVR) for broader patient populations.