Cardiovascular Device Business News

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Last post of the week in The Medical Technology Blog comes from the Cardiovascular Device Business, Espicom’s business publication. Please read on…

Swedish researchers compare risk of stent thrombosis and restenosis in new vs old DESs

Findings from the complete Swedish Coronary Angiography and Angioplasty Registry (SCAAR) have demonstrated that percutaneous coronary intervention (PCI) with ‘new generation’ drug-eluting stents (DESs) was associated with a 38 per cent lower risk of clinically meaningful restenosis and a 50 per cent lower risk of stent thrombosis compared with ‘old generation’ DESs.

Although many trials and studies support the overall early- and mid-term safety and efficacy of first-generation DESs, there has been concern regarding their long-term safety, especially regarding the potential risk of late stent thrombosis as well as late restenosis. New drug-eluting stents (n-DESs) have been developed with the purpose of overcoming the current limitations of the older generation drug-eluting stents (o-DESs).

The purpose of this study was to evaluate the long-term outcome in all patients who underwent stent implantation with bare-metal stents (BMS), o-DESs and n-DESs in Sweden, using SCAAR, a national registry with complete consecutive enrolment. The latter holds data on consecutive patients from 29 centres that perform coronary angiography and PCI in Sweden. The registry is sponsored by the Swedish Health Authorities and is independent of commercial funding. The technology is developed and administered by the Uppsala University Clinical Research Center. All consecutive patients undergoing coronary angiography or PCI are included. Information with respect to restenosis and stent thrombosis has been registered for patients undergoing any subsequent coronary angiography for a clinical reason since the beginning of 2004.

The current study included 94,384 stent implantations in Sweden (BMS, n=64631; o-DES, n=19202; n-DES, n=10551), from November 2006 to October 2010. Follow-up was performed up to two years post-intervention. The performance up to two years of different types n-DES was evaluated in an unselected, large, real-world population – including patients with myocardial infarction, three-vessel and/or left main disease, bifurcation lesions, graft disease, restenotic lesions and chronic total occlusions. The main findings from this study are that PCI with n-DESs was associated with a 38 per cent lower risk of clinically meaningful restenosis and a 50 per cent lower risk of stent thrombosis compared with o-DESs. These findings can be useful for the management of patients with a high-risk profile that could benefit more from these new devices.

Further studies are said to be needed in order to attempt to discriminate whether one of the three components of the n-DES – the polymer, the stent alloy, the eluting-drug – is mainly involved in decreasing the incidence of stent thrombosis and restenosis. Improved stent designs with thinner struts and more biocompatible polymers may have an important impact on drug elution profiles, endothelial coverage and functional recovery.



Espicom Business Intelligence

Will Axis-Shield give into rising pressure of takeover offer from Alere?

The Medical Technology Blog

Alere, a key player in the rapid point-of-care and laboratory diagnostics market with products that focus on infectious disease, cardiology, oncology, drug abuse and women’s health, has brushed aside negative feedback from Axis-Shield and pushed ahead with a cash offer for the UK-based company.

As part of the offer, Axis-Shield’s shareholders will be offered £4.60 (or approximately US$7.51) for each Axis-Shield share held by them, valuing the transaction at approximately £230 million (or approximately US$375 million). The offer will be conditional upon Alere receiving valid acceptances in respect of not less than 90 per cent of Axis-Shield shares to which the offer relates and not less than 90 per cent of the voting rights carried by those shares.

In June, Alere had made an indicative non-binding proposal to acquire Axis-Shield, however, the latter rejected the proposal and also turned down an offer to conduct further discussions with Alere. At the time, Alere revealed that it was keen to work towards a recommended takeover offer for Axis-Shield and that it would welcome the opportunity to discuss a possible transaction in a constructive manner. The company said its proposal was “a means to facilitate discussions” with Axis-Shield and its shareholders. Now, in a move that adds further pressure on its target, Alere has made an additional open market purchase of approximately 6.4 per cent of Axis-Shield’s share capital.

Axis-Shield is an international in vitro diagnostics company, headquartered in Dundee, UK, with R&D and manufacturing bases in Dundee and Oslo. The group specialises in the supply of instruments and tests for the rapidly growing physician’s office testing market and the development, manufacture and marketing of diagnostic kits in areas of clinical need, including cardiovascular and neurological diseases, rheumatoid arthritis, and diabetes. During 2010, the company made significant advances with the continued growth of its international in vitro diagnostics business and revenues exceeded £100 million for the first time.

Alere believes it’s all cash offer is highly attractive for Axis-Shield shareholders, representing a ‘compelling value proposition’ with a high degree of certainty at a substantial premium to the undisturbed share price. In addition, the company expects Axis-Shield will be complementary to its existing businesses and that it can help develop and grow the Axis-Shield product portfolio to be a clear leader worldwide in its core markets.

Over the forthcoming weeks, the question remains as to whether Axis-Shield will succumb to the pressure to reach an agreement Alere, and whether the latter, with revenues of over US$2.1 billion behind it for 2010, has done enough to win over the UK-based company.



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