The recent 12-month clinical trial data from the BIOADAPTOR Randomized Controlled Trial, which evaluated the DynamX Coronary Bioadaptor, shows exciting progress. The trial, performed outside of the U.S., demonstrates a unique mechanism of action for the bioadaptor coronary prosthesis used to treat blockages in the coronary arteries. Instead of “caging” the coronary artery with a metallic scaffold like a coronary stent, the DynamX bioadaptor has the capacity to “unlock” and release the artery while providing dynamic support to the diseased vessel so that it can resume more normal function, increasing blood flow, pulsing to adapt to changes in the heartbeat and maintaining the ability for positive adaptive remodeling.
Dean Kereiakes, M.D., Chairman of The Christ Hospital Heart and Vascular Institute, reviewed the novel technology called DynamX bioadaptor in the prestigious Cardiovascular Revascularization Medicine journal link.
“As a principal investigator in clinical trials used for the U.S. Food and Drug Administration (FDA) approval of more than a dozen different coronary stents, the DynamX bioadaptor is unique among them in offering both “best-in-class” procedural performance and late recovery in more normal coronary vessel physiology,” said Dean Kereiakes, M.D., FACC, MSCAI, Chairman of The Christ Hospital Heart and Vascular Institute. “DynamX bioadaptor may represent a paradigm shift in percutaneous coronary revascularization and could become the new gold standard for treatment in atherosclerotic cardiovascular disease.”
The DynamX bioadaptor successfully accomplished all of these functions when compared “head-on” with a best-in-class metallic drug-eluting coronary stent. The bioadaptor treatment was also associated with plaque stabilization and decrease within the artery segment treated by the device. If these observations are confirmed by the larger, planned trial for FDA approval, the DynamX bioadaptor could further favorably impact long-term clinical outcomes following PCI and would represent a major advance for catheter-based coronary revascularizations.
Globally, patients and providers have seen great strides made in the earlier diagnosis of coronary atherosclerosis. Similarly, progress has been seen in the evolution of PCI technologies, from balloon angioplasty to bare metal stents to drug-eluting stents, with each modification leading to better short-term patient outcomes. The ultimate goal, however, is to be able to return the vessel affected by atherosclerosis disease to a normal function, something rigid stent tubes cannot do, and for which the bioadaptor technology holds the promise.
The Carl and Edyth Lindner Research Center at The Christ Hospital Health Network has participated in more than 1,200 clinical research trials and has introduced many of the new techniques in cardiovascular medicine over the past 25 years. These studies have included first-in-man as well as first-in-the-U.S. experiences with leading-edge techniques.
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About The Christ Hospital Health Network
The Christ Hospital Health Network consists of an acute care hospital located in Mt. Auburn, a remote hospital location in Liberty Township, five ambulatory outpatient centers and dozens of medical offices throughout the region. For more than 130 years, The Christ Hospital has provided compassionate care to those it serves. Made up for more than 1,300 physicians and more than 6,500 team members, our mission is to improve the health of our community by providing exceptional outcomes in an affordable way. The Network was recognized by U.S. News & World Report as the #1 hospital in the Cincinnati Region and named to Newsweek’s World’s Best Hospitals list in 2023. It is also a Press Ganey Guardian of Excellence Award recipient, which recognizes top-performing healthcare organizations that achieve the 95th percentile or above of performance in patient experience.








