ASHEVILLE, NC. (WLOS) — A western North Carolina hospital is at the heart of a clinical trial aimed at reducing the risk of a stroke during heart valve replacement surgery.
HCA Healthcare’s Mission Hospital recently successfully completed its first in-human phase of the clinical trial. The device, known as EmStop, is an innovative stroke protection device developed by a local cardiac care physician. It is designed to catch any dislodged debris during a transcatheter aortic valve replacement or TAVR procedure, preventing the risk of stroke.
“The data was so positive and so favorable that the FDA then approved the next phase of the study called the Capture II study and so that’s what we call a pivotal trial and that’s going to involve up to 25 centers throughout the United States, stretching all the way from California, to the northeast, to the southeast,” said Dr. Michael Chenier, Structural Heart Interventional Cardiologist at Mission Hospital and Principal Investigator on the study.
TAVR is a life-saving alternative to open-heart surgery for patients with severe aortic stenosis, especially for patients at high surgical risk. The threat of stroke from dislodged debris during the procedure has long been a concern for physicians and patients. The embolic protection device aims to make this life-saving procedure even safer by addressing the rare but dangerous risk of stroke…