DynamX Clinical Data

Why Go Beyond DES?

Adverse events remain high with current DES

DynamX Clinical Data
DynamX Clinical Data
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

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 Interp (mm)2.95 ± 0.382.89 ± 0.39
MLD (mm)2.51 ± 0.372.39 ± 0.39
%DS14.7 ± 7.817.0 ± 9.5
Acute Gain (mm)1.39 ± 0.38
Balloon-Artery Ratio1.15 ± 0.12
Late Lumen Loss (mm)0.11 ± 0.14
In-Bioadaptor
RVD (mm)3.08 ± 0.272.98 ± 0.30
MLD (mm)2.75 ± 0.302.63 ± 0.37
%DS5.4 ± 8.17.7 ± 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)
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

30 Day
(n = 50)
6 Months
(n = 49)5
12 Months
(n = 48)6
TLF002
All Death002
Cardiac Death*002
Non-Cardiac Death000
Target Vessel MI000
Clinically Indicated-TLR000
Non-Clinically Indicated TLR000
Definite/Probable Thrombosis000

*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

DeviceTimepointMean NIH Thickness (µM)
DynamX9M7130 ± 50
12M7140 ± 40
Xience9M8124 ± 42
13M9142 ± 113
Resolute9M8139 ± 58
13M9116 ± 99
MiStent8M10132 ± 53

Clinical Roadmap

Robust global clinical program

Study-Design-International
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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