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., 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) FREEWAYTM 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 FREEWAYTM 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.”
Eurocor’s second-generation drug-eluting technology PTA balloon FREEWAYTM 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 – FREEWAYTM 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.