Press Release
Eurocor announces treatment of First Patients in International Randomized Freeride StudyFREEWAY™ drug-eluting balloon used for treatment of de-novo or restenotic lesions in the SFA or Popliteal arteries
Bonn, Germany | Bengaluru, India | January 27, 2012
Eurocor GmbH, an Opto
Circuits group company, 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."
Eurocor is a rapidly growing European Life Sciences Technology Corporation specializing in the research, development and manufacture of cardiovascular and endovascular products. Eurocor provides interventional physicians with innovative coronary stent technologies and special cardiovascular and endovascular devices, manufactured in Bonn. Products are indicated for
Press Release
minimally invasive cardiovascular and peripheral surgery and
comply with biological and biomechanical principles to offer
highly flexible, adaptable solutions. Extensive research and
development, close clinician collaboration, outstanding
quality standard philosophy and global
scientific alliances lead to optimization of clinically
effective technologies. Eurocor has designed an innovative
method for balloon catheter drug delivery with high patient
compliance. One heartbeat ahead™ - with innovative products
such as DIOR® and FREEWAY™.
Eurocor GmbH is a subsidiary of Opto Eurocor Healthcare Ltd. and is part of the Opto Circuits Group.
For more information, please visit www.eurocor.com
About: Opto Circuits(India) Ltd.
Headquarters: Bengaluru, Karnataka, India
BSE: 532391 | NSE: OPTOCIRCUI
Opto Circuits (India) Ltd. (OCI) is a multinational medtech
company in the business of design, development, manufacture
and marketing of healthcare equipment and medical
interventional products. The product profile includes
USFDA-listed, CE-marked cardiac and vital signs monitoring
systems, anesthesia and respiratory care equipment, automated
external
defibrillators, stents, PTA balloons, catheters, body
implants and consumables. Some of OCI's well-
known brands are Cardiac Science , Criticare , Eurocor , Ormed , Mediaidand Unetixs. The company's
key markets are North America, Europe and BRIC countries.
Anna Beck/Nidhi Thind Phone: 080 28521040-42 Email:media@optoindia.com
distribué par | Ce noodl a été diffusé par Opto Circuits India Ltd. et initialement mise en ligne sur le site http://www.optoindia.com. La version originale est disponible ici. Ce noodl a été distribué par noodls dans son format d'origine et sans modification sur 2012-01-28 07:38:46 AM et restera accessible depuis ce lien permanent. Cette annonce est protégée par les règles du droit d'auteur et toute autre loi applicable, et son propriétaire est seul responsable de sa véracité et de son originalité. |
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