Eurocor GmbH announced have launched Freeway, 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 Freeway technology provides interventionalists with an option that avoids amputation and could save up to $50,000 per patient per year [Pharmiweb, 2004].
“The introduction of Freeway 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 Karl-Ludwig Schulte of Evangelisches Krankenhaus Königin Elisabeth in Berlin, Germany. Drug-eluting balloon 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.
Freeway, 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 drug-eluting balloon 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 Freeway 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 drug-eluting balloons 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.