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Eurocor announces the presentation of the 12 months data of the Freeway Stent Study at CIRSE in Copenhagen on Sept. 18, 2017

Date: 2017/09/18

Eurocor announces the presentation of the 12 months data of the Freeway Stent Study at CIRSE in Copenhagen

  • FREEWAY™ drug-eluting balloon for treatment of stenotic or occluded lesions in the SFA or proximal popliteal arteries
  • Freeway Stent Study is completed

Bonn, Germany –September 18th 2017 - Eurocor, an international specialist in medical DEB - technology, services and solutions, announces the presentation of the 12 months results of the Freeway Stent Study at CIRSE in Copenhagen on September 18th.
The Freeway Stent Study was lead-managed by Prof. Dr. Josef Tacke, Klinikum Passau, Germany. The multicenter, open, prospective randomized study investigated the prevention of restenosis in the treatment of Superficial Femoral Artery (SFA) or Popliteal artery (PI-segment) lesions in the legs. The study examined whether implantation of a Nitinol stent followed by post-dilatation with a drug-eluting balloon (DEB) FREEWAY™ is advantageous over Nitinol stenting and post-dilatation by a plain balloon (POBA). The study was conducted in 13 sites in Germany and Austria. 204 patients suffering from de novo lesions that needed to be stented were enrolled and randomized in a 1:1 ratio. Patients have been followed at 6 and 12 months.


The Results at 6 and 12 Months
Final 12 months results of the Freeway Stent Study have been presented at CIRSE (Cardiovascular and Interventional Radiological Society of Europe) congress 2017, Copenhagen, Denmark. The results show a significant better primary patency for the DEB arm compared to the POBA arm at 6 and 12 months follow-up (90.3 % and 77.4% vs. 69.8 % and 61.0 % respectively; p = 0.003 and p = 0.027), analyzed by an independent and blinded corelab. A very low target lesion revascularization (TLR) rate of the FREEWAY™ arm at 12 months highly favors the post dilatation with a DEB over post dilatation with a plain balloon (7.9 % and 17.7 % respectively; p=0.0637). These findings go along with a significant better improvement in Rutherford classification at 6 and 12 months follow-up for the DEB arm compared to the POBA arm (94.9 % and 95.5 % vs. 84.3 % and 79.9 %, respectively; p = 0.027 and p= 0.003).


Prof. Dr. Josef Tacke commented: “In-stent restenosis is a serious problem in the SFA and PI-segment. The 12 months results of our study indicate that Drug-eluting balloons are a good and desirable option to prevent restenosis in patients that need to be stented.”


About FREEWAY™
Eurocor’s second-generation drug-eluting technology PTA balloon FREEWAY™ has been developed as an alternative to the limitations of existing therapeutic options for PAD e.g. restenosis after POBA or stenting. The product provides good crossability, trackability and pushability and can be used where the use of other therapies is limited by the occurrence of high restenosis rates, anatomical challenges and stent fractures.

The coating makes the difference – FREEWAY™ uses a special homogenous coating
Eurocor’s DEB technology utilizes a homogenous drug coating, which is released when the balloon is expanded. This inhibits the proliferation of smooth muscle cells, and may prevent restenosis by disturbing microtubule formation and thereby inhibiting cell division and migration. Paclitaxel is applied in a final concentration of 3 μg/mm² to the surface of the balloon.

-End-







Media Contact
Eurocor GmbH
Katja Hausner
Phone: +49 (0) 228 201 500
Email: pressoffice@eurocor.de



The Company:

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 Europe. Products are indicated for minimally 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 wholly owned subsidiary of Opto Eurocor Healthcare Limited and is part of Opto Circuits Group

For more information, please visit eurocor.de and optocircuits.com