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).
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.
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
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
MACE and Mortality 10 Years — ISAR-Test 414
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 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
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 6 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 9 or 12 months. The 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 as measured by QCA and IVUS at 9 or 12 months
Clinical Roadmap
Robust global clinical program
