Minneapolis Heart Institute Foundation® (MHIF) today announced the first enrollment in the VISTA U.S. early feasibility study offering a new transcatheter tricuspid valve technology for severe tricuspid valve regurgitation. This first successful procedure for a patient in the United States was completed by a multi-disciplinary team at the MHIF Valve Science Center, including Dr. Paul Sorajja, Dr. Vinayak Bapat and Dr. Nadira Hamid. VDYNE, the manufacturer of the new technology, was previously granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).
“We are pleased to complete the first enrollment in this study in the United States as we continue our commitment to advancing care and options for patients living with tricuspid valve disease that is debilitating and significantly impacts quality of life,” said Dr. Sorajja. “This new technology offers another approach to replacing the tricuspid valve where there are currently not a lot of options for patients. We have a depth of expertise in this area of research and welcome the opportunity to continue to drive innovation in new technologies so that we have options for all patients.”
Tricuspid regurgitation is a condition when the tricuspid valve’s flaps (or leaflets) do not close properly. The tricuspid valve controls the flow of blood from the heart’s right atrium to the right ventricle. When the right ventricle of the heart pumps blood from the heart to the lungs for re-oxygenation, a leaky tricuspid valve allows blood to flow backwards, leading to shortness of breath, fatigue, abnormal heart performance and an enlarged heart. VDYNE’s minimally invasive delivery system delivers a prosthetic valve via a transfemoral catheter to replace the body’s “leaky valve”.
The VISTA U.S. early feasibility study is a single-arm study enrolling up to 30 patients suffering from moderate to severe tricuspid regurgitation in the United States. The company is also enrolling in a global (non-US) feasibility study across Europe Union and Australia. The VDYNE tricuspid valve replacement system is under clinical investigation and is not commercially available in the United States of America, or elsewhere.
About Minneapolis Heart Institute Foundation®
The Minneapolis Heart Institute Foundation (MHIF) strives to create a world without heart and vascular disease. To achieve this bold vision, it is dedicated to improving the cardiovascular health of individuals and communities through innovative research and education.
Scientific Innovation and Research – MHIF is a recognized leader across all specialties of heart and vascular research. Each year, MHIF leads more than 220 research studies with more than 2,200 patients and publishes more than 250 articles to share learnings from research. MHIF research has improved the standard of care around the world through protocols like Level One for heart attack, which significantly improved outcomes and survival for patients.
Education and Outreach – MHIF provides more than 11,000 hours of education each year putting its research into practice to improve outcomes among health care providers. This commitment extends to patients and caregivers through community health and education events to raise awareness of heart care and research, engaging individuals in their own health.
The Minneapolis Heart Institute Foundation’s work is funded by generous donors and sponsors and engages in cutting-edge research initiatives with its physician partners from the Allina Health Minneapolis Heart Institute® at Abbott Northwestern Hospital and at 38 community sites across Minnesota and western Wisconsin. For more information, please visit mplsheart.org.
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