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    DynamX® Coronary Bioadaptor by Elixir Medical

    The DynamX® coronary bioadaptor from Elixir Medical introduces pioneering technology to coronary intervention. It combines the acute radial support of a conventional stent with a programmed uncoupling at six months that uncages the artery, restoring natural vascular pulsatility, mobility, and function.

    DynamX® Coronary Bioadaptor by Elixir Medical

    DynamX® Coronary Bioadaptor by Elixir Medical
    DynamX® Coronary Bioadaptor by Elixir Medical

    The DynamX® coronary bioadaptor from Elixir Medical introduces pioneering technology to coronary intervention. It combines the acute radial support of a conventional stent with a programmed uncoupling at six months that uncages the artery, restoring natural vascular pulsatility, mobility, and function.

    Elixir Medical

    The DynamX® drug-eluting coronary bioadaptor system from Elixir Medical, distributed by Biogen Diagnóstica, establishes a transformative therapeutic category beyond conventional drug-eluting stents (DES). Engineered to overcome the long-term clinical constraints of rigid metallic caging, DynamX® delivers optimal acute radial strength following percutaneous coronary intervention (PCI) whilst enabling a revolutionary three-phase biomechanical release mechanism.

    Its proprietary architecture comprises three ultra-thin cobalt-chromium (CoCr L605) helical strands, temporarily joined by unique uncoupling elements and a bioresorbable PLLA base-coating. At approximately six months post-implantation, as the polymer degrades and metabolises safely via the Krebs cycle into carbon dioxide and water, the structure dynamically unlocks. This allows the treated vessel to regain its natural axial compliance, cyclic pulsatility, and adaptive haemodynamic remodelling, significantly reducing late target lesion failures and adverse cardiovascular events.

    Backed by CE Mark Class III certification under the European Medical Device Regulation (MDR) and full national health regulatory clearances, DynamX® incorporates an antiproliferative drug-eluting bioresorbable PLGA surface layer (Novolimus/Sirolimus) to prevent neointimal hyperplasia, offering interventional cardiology and haemodynamic suites an evidence-based standard of care.

    Features

    • Plataforma bioadaptativa de cobalto-cromo L605: estructura de tres filamentos helicoidales individuales de 71 u 80 µm con excepcional conformabilidad y navegabilidad endovascular.
    • Mecanismo triple patentado: desbloqueo estructural a los 6 meses, liberación mecánica de la pared vascular y preservación continua del soporte intraluminal dinámico.
    • Recubrimiento base bioabsorbible de PLLA (~6 µm): mantiene la cohesión y resistencia radial durante los primeros meses críticos de cicatrización y remodelado vascular.
    • Capa eluyente de fármaco antiproliferativo: matriz de polímero PLGA bioabsorbible (< 3 µm) que administra ~5 µg de fármaco por milímetro de longitud con liberación controlada durante 4 semanas.
    • Sistema de liberación de intercambio rápido (RX): catéter de 140 cm de longitud de trabajo con eje distal de nailon flexible e hipotubo proximal de acero inoxidable para una excelente fuerza de empuje (pushability) y trazabilidad.
    • Marcadores radiopacos de alta definición: dos marcadores bajo el balón para un posicionamiento radiológico exacto y marcadores proximales que delimitan la salida de catéteres guía femorales o radiales.
    • Compatibilidad técnica estándar: apto para catéteres guía de 5 Fr (diámetro interno mínimo de 0,058″ / 1,47 mm) y guías coronarias de 0,014″ (0,36 mm).

    Benefits

    • Restoration of physiological pulsatility: re-establishes cyclic systolic and diastolic vessel expansion, restoring natural blood flow patterns absent in caged stented arteries.
    • Preservation of vasomotion and adaptive response: enables the treated coronary vessel to contract and dilate naturally in response to physiological myocardial oxygen demand.
    • Adaptive curvature and angulation: accommodates vessel tortuosity and flexing during cardiac cycles, reducing shear stress concentrations and edge injury.
    • Significant reduction in late adverse events: robust clinical trial evidence demonstrates a substantial reduction in Target Lesion Failure (TLF) compared with standard DES.
    • Positive vascular remodelling: maintains flow lumen volume whilst supporting long-term adaptive vessel enlargement beyond the first year.
    • Exceptional deliverability in complex lesions: low crossing profile and tapered tip designed for navigating tortuous, calcified, or bifurcated anatomies.

    Other data

    • Bioadaptive cobalt-chromium L605 platform: engineered from three individual helical CoCr strands (71 or 80 µm strut thickness) providing high acute radial strength and superior conformability.
    • Proprietary three-phase uncoupling mechanism: acute vessel support, programmed structural uncaging at 6 months, and continuous dynamic vascular compliance.
    • Bioresorbable PLLA base-coating (~6 µm): secures the expansion elements during delivery and early healing phases before benignly bioresorbing.
    • Targeted drug delivery layer: thin bioresorbable PLGA coating (< 3 µm) releasing ~5 µg/mm of antiproliferative agent over a controlled 4-week period.
    • Rapid Exchange (RX) delivery catheter: 140 cm working length with a flexible nylon distal shaft and stainless-steel proximal hypotube for optimal pushability and trackability.
    • High-visibility radiopaque markers: two platinum-iridium markers under the balloon ensuring exact fluoroscopic placement and lesion alignment.
    • Standard interventional compatibility: compatible with 5 Fr guide catheters (minimum inner diameter of 0.058″ / 1.47 mm) and 0.014″ guide wires.
    dynamx bioadaptador coronario elixir medical 4 biogen diagnostica

    Clinical indications

    The DynamX® coronary bioadaptor is indicated for improving coronary luminal diameter and restoring vascular function in adult patients with symptomatic ischaemic heart disease caused by de novo atherosclerotic lesions in native coronary arteries, with reference vessel diameters ranging from 2.25 mm to 4.00 mm.

    Key clinical evidence:

    • BIOADAPTOR RCT published in The Lancet: demonstrated statistically significant superiority in restoring pulsatility and vessel motion compared to standard-of-care zotarolimus-eluting stents (DES), with exceptionally low TLF rates.
    • Long-term intravascular imaging (OCT / IVUS / QCA): confirmed circumferential uncaging at 6 months with preservation of baseline curvature and absence of late recoil.
    • Peer-reviewed findings in the Journal of the American Heart Association (JAHA): confirm restored endothelial function, preserved microvascular circulation, and sustained physiological flow reserve.
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