Study: Elixir Medical’s Coronary Artery Implant is Capable of Moving With Vessel

Elixir Medical is touting study results that show the DynamX Coronary Bioadaptor System, when uncaged, enables rotational motion similar to natural vessels and reduced peak implant stress by 70 percent. The DynamX Bioadaptor is the first drug-eluting coronary artery implant that adapts to vessel physiology by incorporating flexible “uncaging elements” into its design.

“The DynamX Mechanistic Clinical Study previously showed that the bioadaptor enabled positive adaptive remodeling, preserving the vessel lumen to accommodate disease progression, as well as a return towards baseline vessel angulation and a strong safety profile. This recent analysis now demonstrates the ability of the device to twist along with the vessel’s natural motion, and in doing so, subsequently reduce vessel stress. These are exciting characteristics that have the potential to improve patient outcomes,” said Mladen I. Vidovich from the University of Illinois, Chicago.
 
Throughout the cardiac cycle, coronary arteries are exposed to forces with every heartbeat, including stretching, bending, twisting, expansion, torsion and pulsatility. Conventional drug-eluting stents (DES) “cage” the vessel, preventing natural coronary movement of the vessel, leading to adverse clinical events.¹ Long-term studies of DES have shown adverse event rates of 20% at five years² and 40% to 50% at 10 years.³ Clinical studies have shown that a conventional drug-eluting stent prevents positive adaptive remodeling,⁴ vessel compliance, pulsatility and vasomotion in response to the body’s changing blood flow needs.^5,6 Stents have also been shown to cause vessel straightening, which is associated with increased major adverse cardiac events (MACE).⁷
 
The study encompassed an analysis of IVUS imagery from 20 patients participating in the DynamX Mechanistic Clinical Study acquired post-implantation and at nine to 12 months follow-up. Investigators included Mayank M. Kansal, M.D., Beata Wolska, M.D., and Vidovich from the University of Illinois, Chicago, and Stefan Verheye, M.D., from ZNA Cardiovascular Center, Middleheim, Antwerp, Belgium. 
 
By incorporating unique “uncaging elements” in its metallic implant design, the DynamX Bioadaptor allows for the restoration of natural artery function and movement⁸ essential to cardiovascular performance. The DynamX Bioadaptor is designed to achieve sustained superior clinical outcomes by adapting to vessel physiology and restoring positive adaptive remodeling, pulsatility and rotation.
 
Elixir Medical Corporation, a privately-funded company based in Milpitas, Calif., develops next-generation platforms to treat coronary and peripheral artery disease that are designed to restore the adaptive remodeling and pulsatile motion capabilities of the blood vessel. 
 
The DynamX Coronary Bioadaptor System is CE Mark approved. It is not available for sale in the United States.

References
¹ Ding, Zhaohua, and Morton H. Friedman. Dynamics of human coronary arterial motion and its potential role in coronary atherogenesis. J Biomech Eng. 2000;122(5): 488-492.
² 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
³ 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.
⁴ 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
⁵ 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
⁶ 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.
⁷ 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
⁸ 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