Careers
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
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Head of Coronary Revascularization Unit/
Head of Clinical Research Unit
Department of Cardiology,
IRCCS Policlinico S. Donato, San Donato
M.ne, Milan, Italy
Chairman
Dr. Luca Testa, MD, PhD
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Interventional cardiologist
Emodinamica Fondazione
Poliambulanza istituto ospedaliero, Brescia, Italy
Co-Chairman
Dr. Diego Maffeo
