The future of vascular intervention won’t just evolve,
it will adapt.

From the landmark BIOADAPTOR RCT trial

The first device with RCT data demonstrating significantly better effectiveness in early RETURN of vessel function and stabilization of plaques vs. state-of-the-art drug-eluting stent (DES)

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Primary endpoint: target lesion failure at 12 months vs. 2.8% for Resolute Onyx™
(p < 0.001)


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Increase in blood flow with every heartbeat, as pulsatility returns


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Plaque volume regression in lipid rich lesions vs. +10% for DES
(p = 0.008)


The Transformation

1Restore

Intervene,
don’t interfere.

First step in any intervention is restoring blood flow. And, with DynamX you may achieve significant acute lumen gain without compromising the ability for the vessel to naturally heal.

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DynamX Bioadaptor matched the acute performance of Resolute Onyx DES

DynamX vs. Resolute Onyx

Device and Lesion Success Rates

99.6% DynamX
vs
99.6% Resolute Onyx
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DynamX Bioadaptor had similar acute gain as Resolute Onyx DES

DynamX vs. Resolute OnyxDynamXResolute Onyx1.75(±0.52) mm1.66(±0.45) mmPost-procedure in-device acute gain(p = 0.408)
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DynamX achieved low post-procedure % diameter stenosis, similar to Resolute Onyx DES

DynamX vs. Resolute Onyx In-device % diameter stenosis post procedure 10.24%(±5.22)9.56%(±3.77)DynamXResolute Onyx(p = 0.773)

BIOADAPTOR RCT Investigators

Shigeru Saito, MD

Department of Cardiology, Iryohojin Tokushukai Shonan Kamakura General Hospital, Kamakura City, Japan

Holger Nef, MD, PhD

Department of Cardiology and Angiology, University of Giessen, Giessen, Germany

Stefan Verheye, MD, PhD

Interventional Cardiology, ZNA Cardiovascular Center Middelheim, Antwerp, Belgium

Mark Webster, MD

Cardiac Investigation Unit, Auckland City Hospital, Auckland, New Zealand

See the Transformation in Action

Bioadaptive design

The DynamX Bioadaptor scaffold is comprised of three cobalt-chromium helical strands that are linked together by unique unlocking elements. The helical stands separate following natural resorption of the biodegradable polymer coating, allowing for restoration of vessel motion and function.

Proven antiproliferative and bioresorbable coating

  1. The thin top coat polymer maintains coating integrity on the expanded device and allows for controlled drug elution of low-dose Novolimus over 3 months.
  2. The thin bioresorbable polymer basecoat over the entire surface resorbs over 6 months to safely unlock the uncaging elements on the DynamX Bioadaptor.

Restoration of motion and function

DynamX Bioadaptor unlocking allows for uncaging of the artery and restoration of vessel motion and function while continuing to provide dynamic scaffolding support of the diseased vessel wall.