Johnson and Johnson company files product for approval

Cordis Corporation is seeking pre-market approval for an in-stent restenosis indication for Cypher – a sirolimus-eluting coronary stent – from the US food and drug administration (FDA).

A recent study carried out by Cordis, which is owned by Johnson and Johnson, found that patents who used the Cypher stent had “significantly lower incidence of target vessel failure”, which includes cardiac death, heart attack or target vessel revascularisation – otherwise known as the need too reopen the artery.

The research compared Cypher’s performance with that of brachytherapy, which is where radiation is applied to the vessel when patients who have a bare metal stent suffer from restenosis.

Commenting on the study, Dennis Donohoe, managing director and vice president of worldwide clinical and regulatory affairs for the Cordis Corporation, said that the company is “pleased to file this application with the FDA” and that it can “look forward to working with the agency through this review process”.

The trial, published in the Journal of the American Medical Association and entitled Randomized Trial Comparing Sirolimus-Eluting Stent with Vascular Brachytherapy for the Treatment of In-Stent Restenosis Within Bare Metal Stents (SISR), included 384 people and 26 academic and community health centres from across the US.

Cordis has also been in the news recently as the victim of patent infringement. It was found that Boston Scientific infringed stent patents on Cordis’s the Palmaz balloon extendable stents and the Gray patent on flexible balloon extendable stents.

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