MILPITAS, Calif. & PARIS–(BUSINESS WIRE)–Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced at EuroPCR excellent 9 and 12-month clinical and imaging data for the DynamX™ Novolimus-eluting Bioadaptor System, a next-generation coronary intervention system designed to treat blocked arteries via a novel vessel uncaging mechanism. EuroPCR is the annual meeting of the European Association for Percutaneous Cardiovascular Interventions.
Fifty patients were enrolled at 7 centers in Europe in the DynamX Mechanistic clinical trial. Nine-month clinical data for all patients, and 9 and 12-month angiographic and imaging results for 31 followed-up patients were presented for the DynamX Bioadaptor System, which represents a dynamic, new frontier in the percutaneous coronary intervention (PCI) industry for an innovation beyond stenting. Antonio Colombo, MD, Director of Invasive Cardiology, Columbus Hospital, Milan, Italy, and Stefan Verheye, M.D., Ph.D., ZNA Middleheim Hospital, Antwerp, Belgium, were the co-Principal Investigators.
Conventional drug-eluting stents (DES) cage the coronary artery in a rigid, immobile frame inhibiting the vessel’s natural ability to expand in order to preserve the blood flow during disease progression. DES also impede the artery’s physiologic pulsatility and hemodynamics during the cardiac cycle, potentially contributing to further adverse outcomes and accelerated disease progression. Current generation DES have a continually increasing MACE (Major Adverse Cardiac Events) rate that cumulatively translates into high clinical events affecting up to 1 in 2 patients within 10 years.
At 9 and 12 months, Elixir’s DynamX Bioadaptor demonstrated an excellent in-device mean Late Lumen Loss (LLL) of 0.08±0.18 mm and a median LLL of 0.02 mm as measured by QCA.
OCT (Optical Coherence Tomography) imaging results demonstrated impressive 99% strut coverage with a thin and uniform 0.14 mm neointimal layer. IVUS imaging results demonstrated mean Vessel and Device Area increase in the DynamX Bioadaptor-treated segment from post-procedure to long-term follow-up, while maintaining the mean Lumen Area.
“Elixir’s outstanding data demonstrate the engineering ingenuity of the DynamX Bioadaptor for uncaging and restoring the vessel’s natural state to expand and accommodate disease progression thereby maintaining the blood flow lumen and potentially reducing adverse clinical outcomes for patients,” said Dr. Colombo, co-Principal Investigator of the DynamX trial. “I’m delighted to treat my patients with a device presenting such impressive long-term results that far exceed DES capabilities and yet providing DES-like excellent acute performance.”
“Another key attribute for reducing adverse clinical events in patients is preserving the natural angulation of the coronary arteries,” said Dr. Verheye, co-Principal Investigator of the DynamX trial. “Unlike conventional DES that tend to straighten angulated blood vessels due to their rigidity, Elixir’s novel DynamX Bioadaptor demonstrated via multiple case studies its unique ability to restore the pulsatility, positive adaptive remodeling, and natural curvature of the treated arteries, allowing the vessels to elegantly return to their de novo function.”
The positive clinical and angiographic results were presented to a packed audience of physicians and industry executives during the EuroPCR Symposium of “The New Frontier Beyond Stenting for PCI” in Paris, and co-chaired by Dean J. Kereiakes, MD, Medical Director, The Christ Hospital Heart and Vascular Center, Medical Director of the Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, and Professor of Clinical Medicine, Ohio State University, and Martin B. Leon, MD, Mallah Family Professor of Cardiology at the Columbia University Medical Center; Director, Center for Interventional Vascular Therapy; Founder and Chairman Emeritus, Cardiovascular Research Foundation, New York.
“Elixir’s DynamX Bioadaptor represents a pioneering innovation in coronary implant design for the PCI industry by combining the excellent acute performance of DES while categorically surpassing DES with its ability to return the vessel to its de novostate,” said Motasim Sirhan, CEO of Elixir Medical. “Elixir is committed to raising the bar for treatment of cardiovascular disease, and providing physicians with innovative products of the highest standard of care to improve patients’ clinical outcomes.”
About Elixir Medical
Elixir Medical Corporation, a privately funded company based in Milpitas, California, has developed the broadest portfolio of coronary and peripheral stents, scaffolds, and bioadaptors including DESyne, DESyne BD, DESolve, DESolve CX, DESolve NXT, Prava, and the breakthrough DynamX Bioadaptor System. The company’s next-generation systems are designed to return diseased blood vessels to their de novo state. For more information, visit www.elixirmedical.com.
Vinayak Bhat, PhD