KIRKLAND, Wash.– Cardiac Dimensions®, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced the appointment of Angie Swenson as Vice President of Clinical Operations.
Ms. Swenson has spent most of the last 20 years leading clinical trials in the U.S., Europe, Japan and Canada and collaborating on reimbursement strategies for therapies targeting cardiovascular disease developed by leading medtech innovators. Most recently, she served as Vice President, Clinical and Regulatory for HLT, Inc., developer of transcatheter aortic heart valve replacement (TAVR) technology, where for five years she led their early feasibility studies. Prior to that, she was an Associate Director of Clinical Research for C.R. Bard subsidiary Lutonix, overseeing global clinical trials for its drug coated balloons for angioplasty. As Clinical Director for therapeutic hypothermia firm Velomedix, she managed all aspects of a multicenter pilot study of its technology in acute STEMI patients. For St. Jude Medical, she handled overall management of a large multicenter heart valve clinical trial supporting FDA clearance and approvals in Europe, Australia, Canada and Japan, as well as post-market heart valve and renal denervation studies. Earlier in her career, she worked for Beckman Coulter as a Clinical Studies Scientist validating projects for FDA submissions. Her broad experience also includes serving as a medical technologist for Cardiac BioMarkers Trial Lab managing cardiac in vitro diagnostics trials for external sponsors, and as a medical technologist for Hennepin County Medical Center. She holds a Bachelor of Science degree in Medical Technology from Minnesota State University and a certificate in Clinical Trial Management from the University of Chicago Graham School.
“Angie’s rich experience in the successful planning and execution of clinical trials and approvals for medtech therapies addressing important valvular and other cardiovascular diseases is ideally suited to our innovative therapy for mitral valve disease,” said Cardiac Dimensions CEO Rick Wypych. “We look forward to benefitting from her insights and expertise as we focus on enrolling the U.S. pivotal EMPOWER Trial of our Carillon™ Mitral Contour System and exploring reimbursement strategies to support it.”