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Eucalimus

Cr-Co SIROLIMUS DRUG ELUTING CORONARY STENT PREMOUNTED ON RX DELIVERY SYSTEM

Eucalimus is a balloon expandable cobalt-chrome alloy drug eluting stent, premounted on a controlled compliance balloon monorail release system. This biluminal system (Rapid-Exchange technique) is premounted on a semicompliant balloon. The distal lumen is 27 cm in length and accommodates a 0.014’’ (0.36 mm) guide wire, whilst the second lumen is used to inflate and deflate the balloon. The catheter operating length is of 138 cm. the catheter tip is atraumatic. The distal part of the catheter shaft is made of hydrophilic coated polyamide to facilitate advancement within the system, whilst the proximal part is made of steel and PTFE. Two radio opaque markers identify the operating length of the balloon and stent position. Two proximal markers (95 cm and 105 cm from the distal tip) indicate the position of the system compared to the guide catheter. The balloon reaches its nominal diameter at a pressure of 8 bar.

The antiproliferative agent used is Rapamycin (Sirolimus) contained in a biodegradable polymer matrix of PLGA (Polymer Polyglycolic Lactic Acid) 85/15 at a concentration of 1.4 µg/mm2. The PLGA 85/15 polymer coating enables the drug to be eluted rapidly and completely over a period of around 90 days from in-vivo stent implantation and is completely biodegradable. Eucalimus drug eluting stents are able to release the drug they are coated with in a programmed and controlled way, counteracting the intimal proliferation process at the most critical moment. At the same time the polymer is 100% biodegraded in water and carbon dioxide.

Abluminal structure of polymer matrix

The PLGA and Sirolimus matrix is asymmetrically bound to the metal cobalt-chrome structure: the abluminal part is 5 microns thick whilst the luminal part is only 2.5 microns thick. This molecular gradient structure means that the drug is at high densities towards the endothelial wall whilst almost absent within the structure facing the luminal blood flow.

 

INDICATIONS

Eucalimus coronary stents are recommended for patients suffering from symptomatic ischaemic type cardiovascular disease.

eucalimus-cinetica

STENT TECHNICAL DETAILS

DELIVERY SYSTEM SPECIFICATIONS

SIZES AND CODES

COMPLIANCE

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