KIRKLAND, Wash.--(BUSINESS WIRE)--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.”
About the Carillon Mitral Contour System
Cardiac Dimensions is reimagining the solutions available to patients suffering from heart failure by providing a therapy that allows patients to live longer, higher quality lives. Our product, the Carillon Mitral Contour System, is a groundbreaking, non-surgical, minimally invasive device developed to treat patients with mitral valve insufficiency. The Carillon therapy is the only indirect, no-touch mitral valve repair option designed to produce an annuloplasty effect while initiating left ventricular remodeling and improving long-term survival for patients. The Carillon therapy can also be used alongside other heart failure treatments should they be needed.
To date, thousands of patients have been treated with the Carillon system throughout the world. Positive safety and performance data on Carillon therapy encompassing more than 350 patients has been published from four previously completed studies and a real-world registry of the Carillon system. Additionally, the pivotal EMPOWER Trial of the Carillon system is currently enrolling patients in the U.S., as well as in select centers worldwide. The EMPOWER Trial is a randomized, blinded, sham-controlled study of a broad population of patients with heart failure caused by early- through late-stage mitral regurgitation defined as MR grades 1-4. Upon FDA approval, it would be the only medical device solution commercially available as front-line therapy for earlier-stage MR patients with MR grade 1-2 not adequately managed with medications.
The Carillon Mitral Contour System has obtained the CE Mark and Therapeutic Goods Approval (TGA) and is approved for sale in Australia and Europe. It is considered an investigational device in the U.S. For more information, please visit www.CardiacDimensions.com.
About Cardiac Dimensions
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions. Left untreated, secondary mitral regurgitation contributes to heart failure, a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon system addresses the underlying mechanical problem of secondary mitral regurgitation with a catheter-based alternative to medications and invasive surgery.
Cardiac Dimensions has operations in Kirkland, Washington, Sydney, Australia and Frankfurt, Germany.
Cardiac Dimensions, Carillon, and Carillon Mitral Contour System are registered trademarks of Cardiac Dimensions.
