Eurocor GmbH, wholly-owned subsidiary of Opto Circuits India, announced today the launch of FREEWAYTM, the latest second-generation, percutaneous transluminal angioplasty (PTA) balloon technology designed for the treatment of critical limb ischaemia associated with peripheral arterial disease (PAD). Primary amputation rates amongst patients with critical limb ischaemia can be as high as 40% [Norgren, 2007] and the addition of FREEWAYTM provides interventionalists with an option that avoids amputation and could save up to $50,000 per patient per year [Pharmiweb, 2004].
“The introduction of FREEWAYTM arms us with another vital tool in the fight against peripheral arterial disease. It opens a new window of opportunity to treat many patients who may otherwise lose a limb” said Professor-Doctor Karl-Ludwig Schulte of Evangelisches Krankenhaus Königin Elisabeth in Berlin, Germany. Drug-eluting balloon (DEB) technology has advanced the treatment of acute coronary syndromes and coronary artery disease and the extension of the technology to peripheral interventions will help reduce the incidence of restenosis following treatment.
FREEWAYTM, the latest drug-eluting technology from Eurocor, uses the same technology as Eurocor’s DIOR® paclitaxel-coated coronary balloon but applies it to a new patient population – those with critical limb ischaemia as a result of PAD. Eurocor’s DEB technology utilises a shellac film impregnated with paclitaxel, which is released whenever the balloon is expanded. This inhibits the proliferation of smooth muscle cells, and may prevent restenosis by preventing microtubule formation and inhibiting cell division and migration.
Preclinical studies with FREEWAYTM have shown a reduction in neointimal injury and a uniform drug distribution within the arterial wall. Early clinical experiences suggest the technique reduces rates of restenosis in patients undergoing angioplasty of femoro-popliteal arteries, with no additional adverse events. Phase III trials evaluating the prevention of restenosis in patients with peripheral arterial occlusive disease are underway and will be reported soon.
Over 70 international interventionalists and investors gathered at the Crowne Plaza St James hotel in London to hear the latest data on Eurocor’s portfolio of stent technologies. Topics discussed included the application of DEBs for cardiovascular interventions and the opportunity for utilising DEBs in peripheral applications. “This meeting has given us the opportunity to learn more about the practical application of our products and gives us the opportunity to learn directly from the clinicians who are using them. The relationship between Eurocor and clinicians is vital for the continuing development of innovative medical devices for coronary and peripheral interventions” said Katja Hausner, Director of Business Affairs at Eurocor, Bonn, Germany.
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References
Norgren L, Hiatt WR, Dormandy JA et al. Inter-society consensus for the management of peripheral arterial disease (PAD). J Vasc Surg 2007; 45 (suppl S): S5-S67.
Pharmiweb. Peripheral arterial disease (PAD): as significant opportunity for interventional therapies. Available at: http://www.pharmiweb.com/features/feature.asp?ROW_ID=505. 2004. Date accessed: 2 November 2010.
About: FREEWAYTM
FREEWAYTM is a drug (paclitaxel)-eluting balloon dilatation catheter developed by scientists at Eurocor. It is in Phase III clinical trials for the treatment of occluded or stenotic superficial femoral or popliteal arteries. More information available at:
http://www.eurocor.de/products/freeway_014/product_information/
About: Peripheral arterial disease
Peripheral arterial disease (PAD) results from atherosclerosis, which causes narrowing of arteries through build-up of fatty deposits. Advancement of this disease leads to resting pain and limits physical exercise. PAD is associated with myocardial infarction and stroke.
About: Eurocor GmbH
Eurocor GmbH is a Bonn (Germany) based rapidly growing life sciences company specialising in the research and development of cardiovascular catheter products and coronary stent technologies. Eurocor’s products are used in minimally invasive cardiovascular surgery and comply with biological and biochemical principles to offer highly-flexible, adaptive solutions.
Eurocor GmbH is a wholly-owned subsidiary of Opto Circuits India. For further details, please go to www.eurocor.de
About: Opto Circuits (India) Ltd.
Opto Circuits (India) Ltd. (OCI) (BSE Code: 532391; NSE Symbol: OPTOCIRCUI), headquartered in Bengaluru, Karnataka, India, is a multi-national corporation in the business of design, development, manufacturing and marketing of non-invasive healthcare equipment and invasive vascular products. The product profile includes patient monitoring systems, anaesthesia and respiratory care equipment, pulse oximeters, sensors, stents, catheters and balloons. The Group has a consolidated turnover of Rs.1077 crores (FY2010). The company’s key markets are in the US, Europe and Asia. OCI was ranked as one amongst 200 Best Under a Billion companies in Asia-Pacific by Forbes Asia in 2009 and 2008. For further details, please go to www.optoindia.com
