Eurocor announces the completion of the Freeway Stent Study
- FREEWAY™ drug-eluting balloon for treatment of stenotic or occluded lesions in the SFA or proximal popliteal arteries
- 12 Months follow-up of last patient completed
Bonn, Germany - Eurocor, an international specialist in medical DEB - technology, services and solutions, today announced the completion of the Freeway Stent Study.
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 to Nitinol stenting and post-dilatation by a plain old balloon angioplasty (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 6 Months results
Final 6 months results of the Freeway Stent Study have been presented at CIRSE (Cardiovascular and Interventional Radiological Society of Europe) congress 2016, Barcelona, Spain. The results show a significant better primary patency for the DEB arm compared to the POBA arm (91.4 % vs. 74.4 %, respectively; p = 0.003) at follow-up, analyzed by an independent and blinded corelab. The results also show a very low target lesion revascularization (TLR) rate of only 4.1 % after treatment with FREEWAYTM DEB, whereas the POBA group shows a TLR rate of 9.0 %. These findings go along with a significant improvement in Rutherford classification (94.4% vs. 84.3%, respectively; p = 0.027) and a significant improvement in Ankle-Brachial-Index (ABI Index) at follow-up.
Prof. Dr. Josef Tacke commented: “In-stent restenosis is a serious problem in the SFA and PI-segment. The 6 months results of our study have shown, that Drug-eluting balloons are a good and desirable option to prevent restenosis in patients that need to be stented. After the very positive results at 6 months we are now looking forward to the 12 months results of the study.”
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.
- Clinically proven robust coating, with no drug loss on the way to target.
- Balloon lengths of 20 - 150 mm for Ø 2.0-8.0 mm with different shaft lengths
- Excellent catheter flexibility with tapered, hydrophilic shafts and low tip entry profiles
- New high pressure FREEWAYTM AV shunt balloon for improved patency in dialysis access
Source : Eurocor