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.
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Representing one of the most significant implant design breakthroughs in 30 years.
Hover over the icons to learn more about each design.
How DynamX Works for Your CAD Patients
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.
Step 1:
Implanted similar to drug-eluting stent
Step 2:
Drug elutes over 3 months
Step 3:
Polymer coating resorbs over 6 months
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
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 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 Clinical Evidence
The DynamX Mechanistic Clinical Study
Design
- Multi-center, single-arm, mechanistic clinical study
- 50 patients
- 7 international sites
- 2 Principal investigators: Stefan Verheye, MD – ZNA Middelheim; Antonio Columbo, MD, San Raffaele Hospital, Milan
- Treatment of single, de novo lesions
- Followed out to 30 days, 9 and 12 months, 2 and 3 years
Principal endpoints:
- The primary safety endpoint is Target Lesion Failure at six months. TLF is a composite endpoint defined as cardiac death, target vessel MI and clinically-indicated target lesion revascularization
- The primary imaging/efficacy endpoints for those patients undergoing imaging follow-up are the change in mean in-device area and mean lumen area at nine or 12 months. These endpoints are compared to post-procedure as measured by IVUS
- Co-primary imaging/efficacy endpoints for those patients undergoing imaging follow-up are late lumen loss. The endpoints are measured by QCA and IVUS at nine or 12 months
Outstanding Efficacy and Safety Outcomes
Outstanding imaging results show acute gain similar to best-in-class DES and vessel lumen maintained at 1 year
Angiographic Results15
| Post-Procedure, Paired (n=45) | 9 & 12 Month Follow-Up, Paired (n=45) |
|
| In-Segment | ||
| RVD (mm) | 2.95 ± 0.38 | 2.89 ± 0.39 |
| MLD (mm) | 2.51 ± 0.37 | 2.39 ± 0.39 |
| %DS | 14.7 ± 7.8 | 17.0 ± 9.5 |
| Acute Gain (mm) | 1.39 ± 0.38 | — |
| Balloon-Artery Ratio | 1.15 ± 0.12 | — |
| Late Lumen Loss (mm) | — | 0.11 ± 0.14 |
| In-Bioadaptor | ||
| RVD (mm) | 3.08 ± 0.27 | 2.98 ± 0.30 |
| MLD (mm) | 2.75 ± 0.30 | 2.63 ± 0.37 |
| %DS | 5.4 ± 8.1 | 7.7 ± 10.8 |
| Acute Gain (mm) (Mean ± SD) | 1.63 ± 0.34 | — |
| Late Lumen Loss (mm) (Mean ± SD) | — | 0.12 ± 0.18 |
| Late Lumen Loss (mm) (Median, IQR)7 | — | 0.05 (0.02, 0.17) |
Excellent clinical results show no target vessel revascularization (TVR) through 12 months and no device thrombosis through 12 months
Clinical Follow-up15,22
| 30 Day (n = 50) | 6 Months (n = 49)5 | 12 Months (n = 48)6 | 24 Months (n = 45)23 |
|
| TLF | 0 | 0 | 2 | 2 |
| All Death | 0 | 0 | 2 | 2 |
| Cardiac Death* | 0 | 0 | 2 | 2 |
| Non-Cardiac Death | 0 | 0 | 0 | 0 |
| Target Vessel MI | 0 | 0 | 0 | 0 |
| Clinically Indicated-TLR | 0 | 0 | 0 | 0 |
| Non-Clinically Indicated TLR | 0 | 0 | 0 | 0 |
| Definite/Probable Thrombosis | 0 | 0 | 0 | 0 |
*Investigational sites report deaths as not related to device or procedure. Unwitnessed death (Day 255), History of Korsakoff’s Syndrome, No autopsy performed; Adjudicated per ARC-2 as Cardiac Death due to unwitnessed death. Multi-organ failure following Heart Failure Hospitalization (Day 267); Adjudicated per ARC-2 as Cardiac Death due to Heart Failure hospitalization.
Thin uniform strut coverage demonstrates healing – DynamX clinical data shows struts are 99% covered at 12 months7 with neointimal thickness similar to best-in-class DES
OCT NIH Measurements
| Device | Timepoint | Mean NIH Thickness (µM) |
| DynamX | 9M & 12M15 | 140 ± 40 |
| Xience | 9M8 | 124 ± 42 |
| 13M9 | 142 ± 113 | |
| Resolute | 9M8 | 139 ± 58 |
| 13M9 | 116 ± 99 | |
| MiStent | 8M10 | 132 ± 53 |
Additional Resources
PMN 726 Rev B