restore® deb
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Catalog excerpts

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Paclitaxel Releasing PTCA Balloon Catheter Specifically designed for ease of handling, high safety and precise drug delivery Powered by SAFEPAX® Technology The 3rd generation, unique, virtually loss-less matrix. For improved homogeneity of drug transfer and highest coating stability on the market

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Controlled trials confirm the excellent safety profile of RESTORE® Procedural success rates >98% in both ISR and SVD patients1-3 No procedure-related complications with RESTORE in two ISR trials and 160 patients: <1% complication rates1, 3 Similar complication rates to DES in vulnerable SVD patients (p=0.19 for comparison)2 Only DCB with demonstrated low complication rates (~3%) in patients with very small vessels2

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RESTORE SVD China: RESTORE is a proven equal alternative to zotarolimus-eluting stent in patients with coronary small vessel lesions2 Percent diameter restenosis at 9 months Non-inferiority proven at p <0.001 40 35 Non-inferiority threshold 97.5% confidence interval for difference No difference in 12-months rates of target lesion failure between RESTORE and zotarolimus-eluting stent (p=0.47) Multi-centre, randomised, controlled clinical trial in 262 subjects at 12 sites in China. The primary end point was in-segment diameter stenosis after 9 months follow-up. Major adverse events were...

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RESTORE® is indicated for the treatment of: • Coronary in-stent restenosis • Small vessel lesions Ø < 2.5 mm • Side branch dilation of bifurcated coronary artery lesions • De-novo lesion dilation Technical specifications Drug releasing balloon Shaft material Plastic tube and a stainless steel hypotube Balloon material Polyamide blend / Nylon 12 Usable catheter length Length of guide wire lumen Entry profile Guiding catheter compatibility Rated Burst Pressure Paclitaxel coating Ordering Information Balloon lengths (mm) The 3rd generation, unique, virtually loss-less matrix. For improved...

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RESTORE: Leveraging all the benefits from SAFEPAX With RESTORE I am in control of drug delivery to the target site with minimal risk for embolisation Dr YunDai Chen Locally delivered 3 μg/mm2 paclitaxel dose Virtually loss-less matrix Proprietary ammonium salt solution excipient Highly stable coating, with low surface friction Excellent manoeuvrability for maximal control: smooth pushability and optimised tensile resistance Enhanced crossability and trackability No need for a loading tool Designed for maximal procedural safety No major adverse procedural complications reported in two...

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Miglionico M, Mangiacapra F, Nusca A, et al. Efficacy and Safety of Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis in High-Risk Patients. Am J Cardiol 2015; 116: 1690-4. Tang Y, Qiao S, Su X, Chen Y, Jin Z, Chen H, Xu B, Kong X, Pang W, Liu Y, Yu Z, Li X, Li H, Zhao Y, Wang Y, Li W, Tian J, Guan C, Xu B, Gao R, for the RESTORE SVD China Investigators, Drug-Coated Balloon Versus Drug-Eluting Stent for Small Vessel Disease: The RESTORE SVD China Randomized Trial, JACC: Cardiovascular Interventions (2018), doi: https://doi.org/10.1016/j.jcin.2018.09.009. Chen Y, Gao L, Qin...

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