MILPITAS, Calif.--(BUSINESS WIRE)--Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced that the BIOADAPTOR randomized controlled trial (RCT) is expanding to centers in Belgium and Germany. The BIOADAPTOR RCT is evaluating the DynamX™ Coronary Bioadaptor System, the first drug-eluting coronary artery implant that adapts to vessel physiology.
The BIOADAPTOR RCT is a multicenter, randomized, single-blind study enrolling 444 patients from 30 centers in Europe and Japan treated with the DynamX Bioadaptor in a 1:1 randomization to Resolute Onyx™, a leading drug-eluting stent (DES). The primary endpoint of the study is target lesion failure at one year. Secondary endpoints include measures of the implants’ ability to accommodate vessel growth from disease progression and restore artery pulsatility in an imaging subset, as well as other major cardiovascular events.
Shigeru Saito, MD, Director of the Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital, Kanagawa, Japan is the principal investigator of the BIOADAPTOR RCT. Additional country principal investigators for the BIOADAPTOR RCT are:
- Holger Nef, MD, Universitätsklinikum Giessen, Germany
- Stefan Verheye, MD, PhD, Antwerp Cardiovascular Centre/ZNA Middleheim, Belgium
“Drug-eluting stents have been a good technology for opening and supporting blocked coronary arteries for many years; however, published studies show adverse events continue to grow over time. I am enthusiastic about being part of this global BIOADAPTOR RCT examining the new bioadaptor therapy that offers innovation beyond DES. I look forward to studying how the bioadaptor allows for positive adaptive remodeling and restores artery function, which drug-eluting stents cannot provide today, and which may improve clinical outcomes for patients,” said Prof. Nef.
Dr. Verheye said, “In the earlier mechanistic study of the DynamX Bioadaptor at one-year follow-up, the bioadaptor enabled positive adaptive remodeling, inhibition of disease progression, and a return towards baseline vessel angulation. The device has also shown an excellent safety and efficacy profile out to two years, with no target vessel revascularization, myocardial infarction or thrombosis. I have found the DynamX Bioadaptor is as easy to deliver as a current generation DES, with the same excellent acute performance.”
The rigid design of a DES constrains, or “cages,” natural artery movement, restricting its natural ability to accommodate disease progression. This has been associated with major adverse cardiac events (MACE).1 Long-term studies with DES have shown adverse event rates of 20 percent at five years2 and 40 to 50 percent at 10 years,3 demonstrating that MACE grows without plateau after the first year. Clinical studies have shown that a 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, which has been associated with increased MACE.8
The DynamX Bioadaptor is a metal implant with a drug-eluting bioresorbable polymer coating that supports the coronary artery during healing, with radial strength similar to DES. Over six months, the polymer coating dissolves, uncaging the bioadaptor and freeing the artery to move with the natural expansion and contraction of the artery, unlike DES.
Studies have shown that the DynamX Bioadaptor improves vessel function in several ways.9 It enables the vessel to accommodate disease progression and achieve positive adaptive remodeling by increasing vessel area and maintaining lumen diameter, which preserves blood flow to the heart. DynamX restores vessel function and allows for normal vessel pulsatility and motion, enabling it to provide more blood flow in response to the body’s needs during physical activity. It also allows the vessel to return to baseline angulation, which may reduce adverse events.
About Elixir Medical
Elixir Medical Corporation, a privately-funded company based in Milpitas, California, develops next-generation platforms to treat coronary artery disease that are designed to restore the adaptive remodeling and pulsatile motion capabilities of the blood vessel. The company’s mission is to transform the care of patients with heart and vascular disease through innovation.
The DynamX Coronary Bioadaptor System is CE Mark approved. Not available for sale in the USA.
- 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
- 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
- Kufner S, Joner M, Thannheimer A, Hoppmann P, Ibrahim T, Mayer K, et al. Ten-year clinical outcomes from a trial of three limus-eluting stents with different polymer coatings in patients with coronary artery disease: results from the ISAR-TEST 4 randomized trial. Circulation. 2019; 139:325–333. doi: 10.1161/CIRCULATIONAHA.118.038065.
- 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.
- 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
- Verheye S, Vrolix M, Montorfano M, Zivelonghi C, Giannini F, Bedogni F, et al. Twelve-month clinical and imaging outcomes of the uncaging coronary DynamX bioadaptor. EuroIntervention 2020;16;e974-e981