The Christ Hospital Becomes Third in the World to Implant Revolutionary Next-Generation Heart Valve
The Christ Hospital Health Network is pleased to announce it has become the third hospital in the world, and first in the Cincinnati region, to implant the next-generation Tria heart valve under an FDA Early Feasibility Study (EFS) for the treatment of ao
1/24/2020
The Christ Hospital Health Network is pleased to announce it has become the third hospital in the world, and first in the Cincinnati region, to implant the next-generation Tria heart valve under an FDA Early Feasibility Study (EFS) for the treatment of aortic valve disease. Geoff Answini, MD, Medical Director of the Cardiothoracic Surgery Program and J. Michael Smith, M.D., Director of Cardiothoracic Surgical Research at the Lindner Research Center, implanted this innovative flexible polymer heart valve, which has the potential to improve upon durability and thrombogenicity issues of currently available heart valves.
“We are excited to be one of the first in the country to offer this new technology, and further our commitment to advancing cardiovascular care on a national level while providing a unique resource to heart patients in our community,” said Dr. Answini. “The procedure was successfully performed on January 8 and the patient is doing very well and has been discharged.”
The first patient, Mr. Kenneth Abney, was happy to be a part of this trial if it meant helping others and providing more options to patients in the future. As a military physician assistant for 21 years, and 43 years of service, he not only understands the importance of research and advancing technology in the healthcare space, but even more, he has a commitment to sacrifice in order to help others, which he believes this new procedure will do. “I guess it’s the soldier in me,” he explained.
“The opportunity to lead milestone clinical trials and to participate in this breakthrough, groundbreaking technology as one of the first in the country shows how The Christ Hospital continues to offer what no other hospital in our region can,” said Dr. Dean Kereiakes, M.D., Medical Director of The Christ Hospital Heart and Vascular Center, Medical Director of the Christ Hospital Research Institute, and Professor of Clinical Medicine at Ohio State University.
Tria heart valves combine LifePolymer™, an advanced biopolymer material, and a patented design to create a valve with the potential for lowering the cost of medical care given the rising costs of using animal tissue valves and their associated durability and calcification concerns. The valves are robotically manufactured to provide the highest level of quality and precision and allow for future patient customization, while eliminating the variability of human production.
“We are excited to be collaborating with Christ Hospital. The Aortic EFS combined with our progress toward mitral and transcatheter versions of the valves next year have the potential to revolutionize the heart valve industry. We are bringing 21st Century solutions to the worldwide problem of providing high quality products with an attractive value proposition,” stated Ken Charhut, Foldax Executive Chairman.
Foldax’s Tria valves were developed by drawing on expertise from the Commonwealth Scientific and Industrial Research Organization (CSIRO), Caltech’s Division of Engineering and Applied Science and Chemistry Departments and leading clinicians. The Company’s investors include Kairos Ventures and Biostar Capital.
About The Christ Hospital Health Network: The Christ Hospital Health Network is an acute care hospital located in Mt. Auburn with six ambulatory centers and dozens of offices conveniently located throughout the region. More than 1,200 talented physicians and 6,100 dedicated employees support the Network. Its mission is to improve the health of the community and to create patient value by providing exceptional outcomes, the finest experiences, all in an affordable way. The Network has been recognized by Forbes Magazine as the 24th best large employer in the nation in the magazine’s “America’s 500 Best Large Employers” listing and by National Consumer Research as the region’s “Most Preferred Hospital.” The Network is dedicated to transforming care by delivering integrated, personalized healthcare through its comprehensive, multi-specialty physician network. The Christ Hospital is among only eight percent of hospitals in the nation to be awarded “Magnet” recognition for nursing excellence and among the top five percent of hospitals in the country for patient satisfaction. For more than 125 years, The Christ Hospital has provided compassionate care to those it serves.
About The Lindner Research Center:
For the past 25 years, The Carl and Edyth Lindner Center for Research and Education (Lindner Research Center) has provided leading-edge medicines and medical technology research covering a broad spectrum of conditions from obesity, diabetes, coronary disease, hypertension and hyperlipidemia to new vascular interventional devices, adult stem cell therapies, structural heart disease, cardiovascular surgery, heart failure and electrophysiology. Physicians at the Lindner Research Center have conducted more than 1,200 clinical trials including multiple first-in-man and first-in-the-U.S. procedures, which have contributed to best practice standards for the care of patients. For information on current trials, please call 513-585-1777.
About FOLDAX: Headquartered in Salt Lake City, Utah, Foldax is developing long-lasting replacement heart valves with the goal of improving hemodynamic performance and providing a quality of life similar to natural human valves. Tria heart valves are revolutionizing the industry as the first and only biopolymer heart valve platform, utilizing LifePolymer™ material eliminating the use of animal tissue. These long-lasting transcatheter and surgical heart valves are designed to provide sustainable quality-of-life improvement for people with aortic or mitral valve disease. For additional information, visit foldax.com.