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. The device’s ability to accommodate the artery’s dynamic, natural movement has been shown to:

  • Maintain the ability for positive adaptive remodeling
  • Restore vessel function
  • Allow 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

How DynamX Works

DynamX is a cobalt chromium implant coated in a proven bioresorbable polymer and a low-dose anti-proliferative drug. Deployed similar to a DES, it initially supports the coronary artery during vessel healing, demonstrating excellent radial strength.

Over six months, the polymer resorbs, freeing unique “uncaging elements” which 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 can move safely and independently within the frame of the bioadaptor. Once uncaged, DynamX allows the vessel to move naturally and respond to patients’ physiologic requirements in ways that traditional DES has been unable to deliver for millions of patients.

DynamX

Step 1:

Implanted similar to drug-eluting stent

DynamX

Step 2:

Drug elutes over 3 months

DynamX

Step 3:

Polymer coating resorbs over 6 months

DynamX

Step 4:

Uncaging elements release once coating is resorbed

DynamX is uniquely 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

View DynamX in Action

Key DynamX Features

Hover over the icons to learn more about DynamX design.

*71µm strut thickness for 2.25mm – 3.0mm diameters

Unique Design Beyond Drug-Eluting Stents (DES)

Maintains Ability for Positive Adaptive Remodeling

Blood vessels change in size and structure over time. For example, when the blood flow lumina of coronary arteries narrow due to a build-up of fats, cholesterol and other substances from atherosclerosis, arteries expand in diameter. This expansion is the body’s compensating response in order to maintain the blood flow lumen area and is known as positive adaptive remodeling.

Traditional stents are designed to safely and effectively open narrowed vessels, but they are rigid and “cage” the artery. This prevents arteries from exhibiting their natural response to expand and compensate for disease progression. 

Unlike traditional stents, the unique uncaging elements of the DynamX Bioadaptor allow it to expand along with the vessel, maintaining the ability of the coronary artery to exhibit positive adaptive remodeling.

2nd Generation DES

DynamX

Traditional DES open the narrowed vessel but cage the lesion area. This maintains the vessel and device area but the lumen area decreases as the disease continues to progress.

DynamX Bioadaptor

DynamX

DynamX Bioadaptor opens narrowed vessels and then uncages, allowing the coronary artery to compensate for continued disease progression. The device expands with the artery at the lesion site, maintaining the lumen area and good blood flow.

DynamX Mechanistic Clinical Study IVUS Analysis
(n=38 patients)
Post-Procedure9- & 12-Month Follow-UpChange from Post-ProcedureP Value
Mean Vessel Area (mm2)14.11 ± 2.9914.54 ± 3.123%0.017
Mean Bioadaptor Area (mm2)7.39 ± 1.207.74 ± 1.465%0.0005
Mean Lumen Area (mm2)7.39 ± 1.207.36 ± 1.310%0.594
DynamX IVUS Analysis Data Table
Vessel and implant grow to maintain vessel lumen – positive adaptive remodeling

Restores Vessel Function

Allows for Normal Vessel Pulsatility and Motion

Maintaining vascular homeostasis elicits biologic responses that protect against atherosclerosis. The vessel’s ability to stretch radially in response to cyclic strain supports this phenomenon.12

Traditional DES reduce vessel compliance by caging the lesion area, severely reducing normal vessel motion.

Unlike traditional DES, DynamX Bioadaptor has enabled treated vessels to exhibit normal pulsatility and motion.7 The unique uncaging elements are designed to uncouple over six months and allow for normal response to cyclic strain.

Artery cross-section using stationary OCT through multiple cardiac cycles
 
DynamX

Single cycle pulsatility highlighted (orange and blue lines) among multiple pulsatile cardiac cycles

Systole
DynamX

Lumen area: 4.96 mm2
Bioadaptor area: 6.05 mm2

Diastole
DynamX

Lumen area: 5.65 mm2
Bioadaptor area: 6.59 mm2

increase in lumen area

increase in bioadaptor area

increase in blood flow2

Clinical Case Example from DynamX Mechanistic Clinical Study
Comparison of vessel pulsatility

Uncaged DynamX bioadaptor allows for normal vessel pulsatility and motion unlike traditional DES that cage the artery

DynamX Uncaged – Pulsatility Restored

Unstented Artery

DES – Vessel Caged

Stationary IVUS imaging of porcine coronary artery during systole and diastole

Allows for Return Towards Baseline Vessel Angulation

In contrast to the acute beneficial effects of radially expanding a narrowed artery with a stent, straightening of an artery with the same rigid stent may contribute to restenosis and has been shown to be a predictor of major cardiac adverse events (MACE).4 Subsequent straightening of a vessel compared to vessel angulation immediately following implantation is significantly correlated with the occurrence of MACE.4

Conversely, the unique design of the DynamX Bioadaptor has been shown to allow vessels to return toward baseline angulation,15 which may result in a reduction of MACE.

Pre-Bioadaptor

DynamX

Post-Bioadaptor

DynamX

12-month Follow-up

DynamX
Clinical Case Example from DynamX Mechanistic Clinical Study

DES EVOLUTION → BIOADAPTOR REVOLUTION

Hover over the icons to learn more about each design.

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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