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Eurocor announces treatment of First Patients in International Randomized Freeride Study

Date: 2012/01/25

FREEWAY™ drug-eluting balloon used for treatment of de-novo or restenotic lesions in the SFA or Popliteal arteries

Eurocor GmbH announced today that the first patients in the Freeride study have been successfully treated with the drug-eluting balloon (DEB) FREEWAY™. The study is lead-managed by Prof. Dr. Karl-Ludwig Schulte, Vascular Center Berlin/Ev. Königin Elisabeth Hospital in Berlin, Germany. The randomized, prospective, multicentre clinical study is being conducted at a total of 25 sites worldwide and involves 280 patients. The aim of the trial is to investigate the rate of clinically driven target lesion revascularization (TLR) using the Paclitaxel-eluting FREEWAY™ balloon in comparison to an uncoated balloon (POBA) in de-novo or restenotic lesions in the Superficial Femoral Artery (SFA) or Popliteal arteries (PI-segment).

Patients suffering from occluded, stenotic, reoccluded or restenotic lesions of 4 – 15 cm length will be treated either with a Paclitaxel-eluting balloon (Freeway™) or with POBA. A 6 and 12 month Duplex follow-up will be carried out as well as an angiographic follow-up in a subgroup at 6 months. This is an ongoing study and the first angiographic analysis and results are expected in spring 2013.

Prof. Dr. Schulte commented: “Stenotic or blocked lesions are serious problems, particularly in the SFA and PI-segment. Drug-eluting balloons offer a promising solution by reopening the vessel without leaving a stent; we are therefore looking forward to the results of this study. We hope this will result in fewer complications and less suffering for the patient.”

“We are pleased that the first patients have successfully been treated and are doing well. This is a key milestone for the company in its path to prove safety and efficacy of drug-eluting balloons also as a treatment for the SFA and PI-segment” said Dr. Rembert Pogge von Strandmann, Director Clinical Department, Eurocor. “We trust that our DEB technology platform used on the FREEWAY™ balloon offers another significant therapeutic advantage for patients.”

A study overview will be presented on the occasion of the Leipzig Interventional Course (LINC) 2012 during the Eurocor Symposium on January 26th, 4:30 – 6:00 pm, Main Arena. For more details visit: www.leipzig-interventional-course de and www.eurocor.de.

Press Release Eurocor announces treatment of First Patients in International Randomized Freeride Study

Pressemitteilung Eurocor behandelt erste Patienten in internationaler randomisierter Freeride Studie