Occam obtains CE approval for stent

Biosensors International Group has announced that its
Netherlands-based subsidiary, Occam International B.V. has received
Conformite Europeene (CE) Mark approval for the Group's first drug
eluting stent (DES), Axxion.

Biosensors' Axxion DES is a polymer-free system, which incorporates its Calix stent delivery system and the commercially available drug, paclitaxel. The drug is directly coated on the stent over a layer of glycocalix, a substrate designed to improve biocompatibility of the metal stent surface after the drug is released.

This technology is licensed exclusively by Occam from a privately held company in Germany that is a leading designer and manufacturer of ultra-thin coatings.

"The 'polymer-free' approach potentially can reduce concerns about the long term effects of polymer coatings used in competitors' products,"​ said Yoh-Chie Lu, CEO of Biosensors.

"We had expected to receive the CE approval for Axxion in the second half of 2005. We are elated to receive this approval now, barely one month into our expected time period,"​ added Lu.

The CE Mark is an international symbol for medical devices that adhere to strict quality assurance standards issued by the European Union. Products that have received the CE Mark can be sold in the European Union.

Other foreign regulatory agencies, for example, those in Asia, have adopted an approval process that is a combination of the US or European review process. In most cases, the regulatory process in these countries is less difficult, although not avoided, by presenting evidence of the EU approval.

"In anticipation of CE Mark approval, we have already ramped up our manufacturing and marketing preparedness. We are operationally ready to launch Axxion in selected markets, which is an essential part of our long-term strategy to have the commercialisation of our own DES products drive the Group's future revenues,"​ added Steve Thomson, chief operating officer.

Stents have revolutionised the treatment of coronary artery disease, with close to 100 per cent penetration in the US, and 50-60 per cent in the UK. Meanwhile, the market for drug-eluting stents is expected to reach $5.5 billion (€4.6 billion) by the end of this year and $6.3 billion by 2007.

In an attempt to tap into this fast-growing market, a number of companies, including Medtronic, Guidant, Abbott Laboratories and Conor MedSystems are developing first-generation products, aiming for improvements over bare metal stents at least as good as those achieved by Cypher and Taxus.

For example Medtronic reported the results of the ENDEAVOR II trial at the ongoing ACC annual meeting yesterday, and initial reactions from the show suggest that the data is strong enough to secure approval. The company intends to launch its DES, which delivers the drug ABT-578 in Europe in 2007 and the US in 2008.

Meanwhile, Cordis and Boston Scientific are both working on ways to improve the properties of their existing stents. For example, Boston Scientific recently won approval for a variation on Taxus called the Taxus Liberte stent.

This has the same drug delivery system and the same drug, but a refined design that should make delivery and deployment of the stent easier, and potentially broaden its use into blood vessels for which its forerunner would not have been suitable.

And Medtronic and Guidant are also developing stents made of cobalt chromium, a lighter, thinner material than that used in the current generation.

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