DynamX

Innovation Beyond DES:
The DynamX Coronary Bioadaptor System

The DynamX Drug Eluting Coronary Bioadaptor System is a significant innovation in the treatment of coronary artery disease. Going beyond drug-eluting stents (DES), DynamX represents one of the most significant breakthroughs in implant design in the past 30 years.

DynamX is the first coronary artery implant designed to adapt to vessel physiology by:

  • Maintaining the ability for positive adaptive remodeling
  • Restoring vessel function
  • Allowing for return towards baseline angulation

The loss of vessel movement, which occurs with DES, has been associated with major adverse cardiac events (MACE).13 By adapting to the vessel, DynamX offers the potential to reduce the incidence of MACE.

DynamX is not approved by the United States Food and Drug Administration (FDA).

DynamX 2

How DynamX Works

DynamX is a cobalt chromium implant coated in a proven bioresorbable polymer and a low-dose anti-proliferative drug. It is designed to deploy similarly to a DES and initially support the coronary artery during vessel healing.

Over six months, the polymer coating is intended to resorb. This frees unique “uncaging elements” on the device. The uncaging is designed to allow DynamX to move along with the natural expansion and contraction of the vessel. 

These uncaging elements are located at low stress regions of the device’s sinusoidal rings that are intended to move safely and independently within the frame of the bioadaptor.

DynamX 2

Step 1:

Implanted similar to drug-eluting stent

DynamX 2

Step 2:

Drug elutes over 3 months

DynamX 2

Step 3:

Polymer coating resorbs over 6 months

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Step 4:

Uncaging elements release once coating is resorbed

Unlike traditional DES, DynamX is designed to adapt to vessel physiology, activity level and disease progression

This device is very promising and may actually mitigate the problems of the annually occurring events we see with DES.

Stefan Verheye, MD, PhD
Co-principal investigator, DynamX Mechanistic Clinical Study, senior interventional cardiologist, Antwerp Cardiovascular Centre/ZNA Middleheim, Belgium

Why Go Beyond DES?

Adverse events remain high with current DES

DynamX 2
DynamX 2
MACE and Mortality 10 Years — ISAR-Test 414
Elixir-Website-Assets_Graphics_10-15-20_Graph-Dynamx-MACE-3
Elixir-Website-Assets_Graphics_10-15-20_Graph-Dynamx-DoCE
MACE and DoCE – RESOLUTE All Comers3
*Combination of cardiac death, myocardial infarction not clearly attributable to a nontarget vessel and clinically indicated target lesion revascularization

Adverse Events Continue to Accrue at a Rate of 2-3% Per Year with No Plateau

Traditional DES permanently “cage” the artery and constrain natural coronary artery movement, which has been associated with MACE.4

  • Prohibits positive adaptive remodeling
  • Inhibits pulsatility and prevents artery dilation in response to body’s changing blood flow needs 5

Traditional DES can longitudinally stretch or straighten the arteries.4

  • Longitudinal stretch may contribute to MACE and stent restenosis severity

Adverse events, which occur after the first year at a rate of approximately 2 to 3% per year, may be attributed to strut fractures, loss of vessel compliance, vasomotion and the capability for vascular adaptive remodeling, coverage of side branches and the development of late neoatherosclerosis.

Stone et al. JAMA Cardiology 2019

Clinical Roadmap

Robust global clinical program

Study-Design-International
PMN 581 Rev A
Elixir-Medical-Corporation-Coronary-Device

Corporate Headquarters
920 N. McCarthy Blvd
Milpitas, CA 95035 U.S.
+1.408.636.2000
info@elixirmedical.com

Elixir, Innovation for Life and DESyne are registered trademarks, and DynamX a trademark, in the US and internationally for Elixir Medical Corporation.
DynamX Coronary Bioadaptor System and DESyne X2 Novolimus Eluting Coronary Stent System are CE Mark approved.
©2020 Elixir Medical. All rights reserved.
International (OUS) Use Only. DynamX and DESyne X2 are intended to improve coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

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