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Valentines Trial II results presented at EuroPCR 2012 in Paris

Date: 2012/05/18

DIOR® Paclitaxel-eluting balloon shows effective and safe treatment for de novo lesions
Treatment with DIOR® Paclitaxel-eluting balloon shows an overall TLR rate of 2.9% at 8 months post treatment

Paris, France I Bonn, Germany – May 18, 2012 – The eight month results follow-up data from Eurocor’s Valentines Trial II Global Registry was presented by Dr. Antonio Serra at EuroPCR in Paris on Tuesday, 15th May. During the session 2012 “Status of Drug-Eluting Balloon Therapy” Dr. Serra, one of the Principle Investigators, presented data of the multi-center, international, short-term Valentines Trial II. The Registry was conducted with an objective to assess the efficacy of the Paclitaxel-eluting balloon DIOR® for de novo lesions at 6-9 months follow-up. 103 patients suffering from de novo lesions were enrolled by 38 Investigators from 16 countries starting between February 14th and March 31st 2011. A follow-up rate of 99 % was reached with a 50.5% on-site Clinical Monitoring. The trial was carried out by three Principal Investigators: Dr. Antonio Serra, (Barcelona, Spain), Dr. Alfredo Rodriguez (Buenos Aires, Argentina) and Prof. Dr. Fazila Malik (Dhaka, Bangladesh).

The Results: The eight-month results convincingly show that the DIOR® DEB is a safe and effective treatment for cases of de novo lesions. The treatment with DIOR® DEB resulted in a very low overall target lesion revascularization (TLR) rate of 2.9% and a target vessel revascularization (TVR) rate of 6.9%. Also, the overall major adverse cardiac event (MACE) rate of 8.7% was remarkably low. The preliminary late lumen loss (LLL) upon angiographic follow-up of a small subset of patients was 0.30 ± 0.36 mm and 0.33 ± 0.37 mm for the in-DEB segment and in-segment analyses, respectively. A subgroup analysis of the patients suffering from diabetes (28.2%) show that the DIOR® DEB is effective in this population with a single digit TLR rate of 6.9% and a TVR rate of 13.8% at 6-9 months follow-up post treatment. The non-diabetic group of patients shows a TLR rate of 1.4% and a TVR rate of 4.1% at 6-9 months follow-up.

Dr. Antonio Serra commented: “The results of the Valentines Trial II data confirm the excellent results that were obtained already in the Spanish Multicenter Registry which investigated safety and efficacy of DIOR® DEB treatment for de novo lesions in small vessels. With the now available results for Valentines Trial II we can prove that this is also true for de novo lesions in vessel with diameter of ≥ 2.5mm.”

Dr. Rembert Pogge von Strandmann, Director Clinical Department said: “We are happy to see furthermore positive results and clinical evidence of our DIOR® drug-eluting balloon in several clinical studies. We are confident that our DEB technology will result in significant therapeutic advantages for the patients and show a promising alternative therapeutic treatment option in the field of vascular interventions. The DIOR® DEB can be considered as a good treatment option for patients suffering from stenotic lesions, in-stent restenose or de novo lesions.”

Detailed Trial Results available at:

Press Release: Valentines Trial II results presented at EuroPCR 2012 in Paris

Presentation of Valentines Trial II results at CRT2012