Eucomed leader receives IVEC award

by emma 7. November 2011 12:19

John Wilkinson

John Wilkinson (pictured), Chief Executive of Eucomed, has received a special Career award from the International Vascular and Endovascular Course (IVEC) in Milan.

The award recognises the medtech industry’s contribution to the development of vascular and endovascular surgery.

IVEC Chairman Giorgio Biasi presented the award to John Wilkinson to “honour the excellence of a distinguished scientist and eminent colleague who has contributed enormously in promoting, divulging and spreading culture, development and achievements in the field of vascular and endovascular techniques.”

Following the award presentation, Wilkinson gave the Edmondo Malan Lecture on ‘Development and Achievements in Endovascular Procedures as a Result of a Continuous and Ingenious Co-operation between Physicians and Industry’.

He discussed the long history of collaborative working between clinicians and industry over 200 years, with ideas from doctors and surgeons being developed by companies, culminating in such revolutionary devices as the drug-eluting stent.

Wilkinson also emphasised the need for innovation to be built on a platform of ethical interaction and transparency, and for industry to support education and training in the delivery of new therapies.

Finally, he drew attention to the demographic and economic challenges facing Europe’s health systems, and called for a collaborative approach between all stakeholders to support innovative solutions to these urgent problems.

Eucomed is the leading European medical technology industry association. It represents 4,500 designers, manufacturers and suppliers of medical technologies.

FDA approves Xience Prime stent

by emma 2. November 2011 14:43

Medtech Product News

The FDA has approved Abbott’s next-generation Xience Prime drug eluting stent to treat patients with complex coronary artery disease.

The Xience Prime Everolimus Eluting Coronary Stent System is based on the company’s cobalt-chromium stent technology and is designed to enhance deliverability, flexibility, and more accurate stent placement in patients with symptomatic heart disease due to de novo native coronary artery lesions.

The approval was based on results from the SPIRIT PRIME clinical trial, a prospective, multi-centre, open-label trial involving 500 patients with coronary artery disease at more than 60 centres in the US and Australia. Clinical results show that the trial met its primary endpoint of low rates of target lesion failure (TLF) at one year.

Dr Marco Costa, principal investigator of the SPIRIT PRIME trial, said: “Drug-eluting stent technology continues to advance, leading to improved outcomes for patients with coronary artery disease.”

He said that the medical device “will improve our ability to access challenging, complex lesions, and thereby improve care for our patients”.

Robert Hance, Senior Vice President at Abbott Vascular, said that the FDA’s approval “expands the range of treatment options that we can offer physicians for the benefit of their patients with coronary artery disease”.

Xience Prime received CE Mark Approval in 2009.

Abbott recently split into two companies, one concentrating on research-based pharmaceuticals and the other (Abbott) on medical products.

Cordis to stop making stents

by diana 28. June 2011 13:32

Cypher Cordis, the creator of the first drug-eluting stent (DES), is pulling out of the DES business due to increased competition and stalled growth of what was once a blockbuster medical device.

The company, a Johnson & Johnson subsidiary, will discontinue sales of its Cypher (pictured) and Cypher Select stents by the end of this year and will cease development of its new Nevo stent.

J&J will restructure the Cordis business, cutting up to 1,000 jobs and closing its stent manufacturing plants in Puerto Rico and Ireland.

Cordis will continue to make stents for peripheral blood vessels, expanding its product portfolio for endovascular procedures and developing a new stent to treat aneurysms in the abdominal aorta. It also intends to develop its interventional cardiology business, Biosense Webster.

“Due to evolving market dynamics in the drug-eluting stent business, we see greater opportunities to benefit patients and grow our business in other areas of the cardiovascular device market,” said Seth Fischer, global chairman of Cordis. “We will continue to bring innovative cardiovascular solutions to patients in the future.”

The Nevo stent had shown favourable results in a 12-month clinical trial. Its new reservoir (RES) technology promised a new approach to stent drug delivery, with the drug released from within the stent struts. It has not yet been announced whether the stent will be sold to another company.

Once a market leader in the DES segment, Cordis has recently lost market share to competitors including Abbott Laboratories, Boston Scientific and Medtronic.

In addition, last month a US jury trial found Cordis guilty of infringing Boston Scientific’s patent for small-diameter stents, awarding damages of $19.5m; and this month the US Court of Appeals has upheld a decision ordering Cordis to pay $22m in damages to Spectranetics for infringement of a stent manufacture patent.

These problems are combined with a global decline in the DES market due to concerns over the risk of late thrombosis: a report by Swedish doctors in 2006 claimed that DES use increased the rate of these fatal events, causing sales of the device to fall from $5.1bn in 2005 to $3.9bn in 2007.

Cordis introduced the first drug-coated stent, the Cypher stent, in 2002 and, together with Boston Scientific, dominated the stent market until 2008. However, market research consultants Frost & Sullivan estimate that the company now holds only 10–15% of the market share.

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