PARIS – June 25, 2020 — Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced outstanding 12-month data for the DynamX™ Coronary Bioadaptor System, the first coronary artery implant that adapts to vessel physiology. Results will be presented live tomorrow at 14:12 CEST on the Main Arena channel of the PCR e-Course as part of the Late Breaking Trials session by Stefan Verheye, MD, PhD, co-principal investigator and senior interventional cardiologist at the Antwerp Cardiovascular Centre/ZNA Middleheim, Belgium.
Twelve-month results for the DynamX Bioadaptor demonstrate:
- No target vessel revascularization
- No device thrombosis
- Vessel and implant expansion (3% and 5% increase in mean area, respectively) and no loss of mean lumen area, demonstrating positive adaptive remodeling and the device’s ability to preserve blood flow over time
- Mean acute gain of 1.63mm (±0.34), demonstrating radial strength
- In-device mean late lumen loss of only 0.12mm (±0.18), demonstrating the ability of the device and drug coating to inhibit disease progression
“Coronary arteries naturally have the ability to expand with disease progression in order to maintain blood flow to the heart,” said Antonio Colombo, MD, co-principal investigator and director, Cardiac Catheterization Laboratory, Columbus Hospital, Milan and Coordinators Cardiac Catheterization Laboratories GVM Group, Care and Research, Lugo (RA), Italy. “Drug-eluting stents (DES) cage the coronary arteries and hinder this physiological response. DynamX is the first metallic coronary artery implant to demonstrate positive adaptive remodeling of the vessel, enabling it to expand to accommodate disease progression. This may improve longer-term clinical outcomes.”
“The innovative DynamX Bioadaptor design was shown to match current drug-eluting stents (DES) in acute performance while offering the promise to improve upon the high adverse event rates that continue beyond year one with DES,” said Dr. Verheye. “In all measures, including clinical, QCA, IVUS, OCT, the bioadaptor demonstrated excellent performance and safety.”
The DynamX Bioadaptor is the only metallic drug-eluting coronary artery device designed to open and support the artery during healing, like a stent, while uniquely accommodating the vessel’s ability to grow in response to disease progression, which current DES cannot do.
The bioadaptor is designed to address the two to three percent adverse event rate that occurs with drug-eluting stents (DES) each year without plateau.1,2,3 The rigid design of DES constrains, or “cages,” natural artery movement, which has been associated with major adverse cardiac events (MACE).4 Clinical studies have shown that DES prevents positive adaptive remodeling,5 inhibits vessel compliance and dilation in response to the body’s changing blood flow needs,6,7 and causes vessel straightening.8
“While DES do an efficient job supporting the coronary artery, they permanently cage the vessel and show an adverse event rate that continues to build year-over-year without end. Physicians and their patients deserve a technology that treats coronary artery disease without making this compromise,” said Elixir Medical CEO Motasim Sirhan. “Elixir’s DynamX Bioadaptor stands as the only technology that has solved this conundrum. By creating a coronary artery device that restores the normal function of the artery, we expect to demonstrate safety and efficacy with a reduction in clinical events.”
The multi-center, single-arm, mechanistic clinical study enrolled 50 patients treated at six centers in Europe to evaluate the safety and performance of the device in de novo native coronary arteries. Primary endpoints included Target Lesion Failure (TLF), as well as QCA, IVUS and OCT measures.
The DynamX Bioadaptor is a metal implant coated in a drug-eluting bioresorbable polymer that initially supports the coronary artery during healing with radial strength, similar to DES. Over six months, the polymer coating dissolves, freeing couplers – or “uncaging elements” – on the rings to move with the natural expansion and contraction of the artery. This has been shown to (a) maintain the ability for positive adaptive remodeling, (b) restore vessel function, and (c) allow for the vessel’s return towards baseline angulation.
Prof. Verheye’s presentation will also be available on-demand following the Late Breaking Trial session at PCR Online.
ABOUT ELIXIR MEDICAL
Elixir Medical Corporation, a privately-funded company based in Milpitas, California, develops next-generation systems to treat coronary artery disease that are designed to restore the normal pulsatile motion and adaptive remodeling capabilities of the blood vessel. The company’s mission is to transform the care of patients with heart and vascular disease through innovation.
DynamX Coronary Bioadaptor System is CE Mark approved. Not available for sale in the USA.
- Iqbal J, Serruys PW, Silber S, et al. Comparison of zotarolimus- and everolimus-eluting coronary stents: final 5-year report of the RESOLUTE all-comers trial. Circ Cardiovasc Interv. 2015;8(6):e002230. doi:10.1161/CIRCINTERVENTIONS.114.002230
- Gada, H, Kirtane, A, Newman, W, et al. (2013). 5-Year Results of a Randomized Comparison of XIENCE V Everolimus-Eluting and TAXUS Paclitaxel-Eluting Stents. JACC. Cardiovascular interventions. 6. 10.1016/j.jcin.2013.07.009.
- Smits, PC, Valchojannis, GJ, McFadden, EP, et al. Final 5-Year Follow-Up of a Randomized Controlled Trial of Everolimus- and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice. J Am Coll Cardiol Intv. 2015 Aug, 8 (9) 1157-1165.
- Stone GW, Kimura T, Gao R, et al. Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up: A Systematic Meta-analysis and Individual Patient Data Pooled Study. JAMA Cardiol.2019;4(12):1261–1269. doi:10.1001/jamacardio.2019.4101
- Nakamura M, Yock PG, Bonneau HN, et al. Impact of peri-stent remodeling on restenosis: a volumetric intravascular ultrasound study. Circulation. 2001;103(17):2130-2132. doi:10.1161/01.cir.103.17.2130
- Maier, W, Windercker, S, Kung, A, et al. Exercise-Induced Coronary Artery Vasodilation Is Not Impaired by Stent Placement. Circulation. 2002; 105(20): 2373-2377. doi: 10.1161/01.cir.0000016360.97819.44
- Hamilos, M, Sarma, J, Ostojic, M, et al. (2008). Interference of Drug-Eluting Stents With Endothelium-Dependent Coronary Vasomotion Evidence for Device-Specific Responses. Circulation. Cardiovascular interventions. 1. 193-200. 10.1161/CIRCINTERVENTIONS.108.797928.
- Gyöngyösi M, Yang P, Khorsand A, Glogar D. Longitudinal straightening effect of stents is an additional predictor for major adverse cardiac events. Austrian Wiktor Stent Study Group and European Paragon Stent Investigators. J Am Coll Cardiol. 2000;35(6):1580-1589. doi:10.1016/s0735-1097(00)00570-2