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1. Parts of both stent and balloon are coated
The stent is been coated in a pre-crimped condition and hence both the stent as well as balloon are coated to enhance drug delivery area

2. Treatment of Diffused Lesion and Focal Restenosis
The most complex lesions are been addressed because of the burst release of drug (Balloon) and Programmed release of drug (Stent).

3. Abluminal Coating
The coating is on the abluminal side of the stent which helps in faster re-endothelialization.

4. Hybrid Stent
The stent has a hybrid design platform which comprises of open cells in the mid segment while closed cells at the edge. Hence, has also better bifurcation access area.

5.Thin Bio-absorbable Film – Acute  MI 
The bio-absorbable film acts as a protective layer and it restrict “slow flow – no flow” movement.

TECHNICAL SPECIFICATION

Drug | Polymer
Drug Sirolimus
Drug Dose 0.70 mcg/mm2
Drug Carrier Lactice and glycolide family of biodegradable polymer
Stent
Stent Material Cobalt Chromium Alloy L605
Strut Thickness 73 micron (0.0029”)
Strut Width 80 micron (hinge) – 120 micron (strut)
Average Recoil Less than 5%
Average Foreshortening Less than 1% (zero foreshortening design)
Delivery System
Delivery System Rapid exchange (Rx) stent delivery system
Nominal Pressure 8 bar
Rated Burst Pressure 14 bar

DEDICATE  
CLINICAL REGISTRY

A NOVEL DRUG ELUTING STENT FOR DIABETIC PATIENTS IN CORONARY ARTERY DISEASE TREATMENT

The DEDICATE REGISTRY is designed to establish long term benefits of unique and innovative product design of Abluminus in Diabetic indication globally.

OBJECTIVE

To evaluate the performance of a novel ABLUMINUS® DES+ sirolimus eluting stent in patients with Diabetes Mellitus

DESIGN

Prospective, Observational, Multi‐center clinical registry to be conducted in Europe at Interventional cardiology centers. 1000 patients will be enrolled and evaluated.

All the patients will be followed up for up to 5 years.

PRIMARY ENDPOINTS

Target Lesion Failure, which is composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization within 12 months

SECONDARY ENDPOINTS

Stent thrombosis [Time Frame: 1 month, 12 months, yearly]: Definite and probable stent thrombosis according to ARC definitions
Cardiac death [Time Frame: 1 month, 12 months, yearly]
Target Vessel Myocardial infarction [Time Frame: 1 month, 12 months, yearly]
Target Lesion Revascularisation [Time Frame: 1 month, 12 months, yearly]
Device Success at 24 hours
Lesion Success at 24 hours
Procedural Success at 24 hours

  • Head of Coronary Revascularization Unit/
    Head of Clinical Research Unit
    Department of Cardiology,
    IRCCS Policlinico S. Donato, San Donato
    M.ne, Milan, Italy

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    Dedicate Industrial Professional - Envision Scientific - Advancing Innovation

    Chairman

    Dr. Luca Testa, MD, PhD

  • Interventional cardiologist
    Emodinamica Fondazione
    Poliambulanza istituto ospedaliero, Brescia, Italy

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    Dedicate Industrial Professional - Envision Scientific - Advancing Innovation

    Co-Chairman

    Dr. Diego Maffeo

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