Insistent

The Insistent Sirolimus eluting stent system is a combination product comprised of two regulated components: a device (a coronary stent system) and a drug product (a formulation of Sirolimus contained in a polymer coating) pre mounted on balloon catheter between two GOLD 18K / Platinum Iridium radio opaque marker bands.

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Description

The component is coated on the stent. This coating consists of a blend of Sirolimus drug (the active ingredient) and biodegradable polymers (the inactive ingredient).

Sirolimus is a Macrocyclic lactone produced by Streptomyces hygroscopicus.

Insistent has proven drug release kinetics Initial Burst Release of 30%-40% Sirolimus in the first week followed by sustained release upto 90 days to maintain therapeutic Sirolimus drug concentration to optimize the anti-tissue proliferative action.

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