A Medical Device Daily

Biosensors International (Singapore) said that its European subsidiary, Occam International (Eindhoven, the Netherlands), has received CE mark approval for the company’s first drug-eluting stent (DES), Axxion, allowing its sale in the European Union.

The Axxion DES is a polymer-free system that incorporates Biosensors’ Calix stent delivery system and the drug paclitaxel, which 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 manufacturer of ultra-thin coatings that according to Biosensors, “set unsurpassed standards of efficiency, hemocompatibility and biocompatibility.”

Yoh-Chie Lu, chairman and CEO of Biosensors, said, “The ‘polymer-free’ approach potentially can reduce concerns about the long-term effects of polymer coatings used in competitors’ products.”

Lue added: “We had expected to receive the CE mark approval for Axxion in the second half of 2005, [so] we are elated to receive this approval now, barely one month into our expected time period.”

Chief Operating Officer Steve Thomson said, “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 commercialization of our own DES products drive the group’s future revenues.”

Biosensors said it expects European sales of Axxion to contribute to the company’s revenues for the current fiscal year ending March 31, 2006, prior to receiving regulatory approval of its flagship DES system, BioMatrix, for which a CE mark filing was made in April.

The BioMatrix DES system incorporates the company’s proprietary anti-restenotic drug, Biolimus A9, bioresorbable polymer, S-Stent and stent delivery catheter, all of which have been developed in-house. Biosensors said it expects to receive CE mark approval for the BioMatrix in the first half of calendar 2006.

NHS dentistry reform moves forward

The next steps to modernize and reform National Health Service (NHS) dental services in the UK were outlined by Health Minister Rosie Winterton last week. The measures include a new system of dental charges and outlining a new NHS contract for dentists.

The proposals will build on the current phase of the dental modernization agenda, which included recruiting the equivalent to 1,000 additional NHS dentists, increasing undergraduate training places and devolving funding to local Primary Care Trusts.

The new dental charges system will scrap the outmoded and complex “fee scale” system where dentists have to claim separately for every single item of treatment they carry out, involving 400 individual charges.

The new system groups all dental treatment into three easy to understand bands that will make charges fairer and less confusing for patients, and less bureaucratic for dentists to administer.

It means, Winterton said, that dental patients will know exactly how much they are being charged before they receive their treatment. Under the new system the maximum cost of NHS dental treatment would be reduced by more than half and existing exemptions, including children under 18 and those on income-related benefits will be maintained.

Payment Band 1 covers preventive dental work, such as scaling and polishing and the provision of oral health advice, at the cost of 15. Band 2, which requires a payment of 41, covers simple treatment such as fillings and extractions. Band 3 covers more complex treatment, such as bridgework, crowns or dentures, and involves a payment of 183.

Under this new plan, patients will make one single payment for their course of NHS treatment. For example, a patient requiring a filling would pay a single Band 2 payment that would cover both the initial examination and the filling.

The traditional basic “checkup” will be replaced with a more comprehensive oral health assessment, which will include any necessary X-rays, scale and polish, and oral health advice. Winterton said this reflects NHS dentistry’s shift away from invasive treatment to prevention of dental disease through patient education.

The new dental charges system reflects recent guidance from the National Institute for Clinical Excellence (NICE), which advises that patients be recalled between three and 18 months, depending on their clinical need – as opposed to the traditional six-month recall, which NICE said is unnecessary for a large majority of the population.

Winterton also outlined new contractual arrangements for dentists that will take effect in April 2006. The new contract will encourage the promotion of oral health and pay them for the overall service they provide to a patient, rather than for each of the individual treatments they carry out.

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