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restore® deb

restore® deb

restore® deb

Product catalog summary
Overview: The Paclitaxel Releasing PTCA Balloon Catheter, branded as reStore® DeB, is designed for ease of handling, high safety, and precise drug delivery. It utilizes SAFEPAX® Technology, a third-generation matrix that ensures improved drug transfer homogeneity and coating stability.
Clinical Trials and Safety: Controlled trials have confirmed the excellent safety profile of RESTORE®, with procedural success rates exceeding 98% in both in-stent restenosis (ISR) and small vessel disease (SVD) patients. Complication rates are less than 1% in ISR trials and comparable to drug-eluting stents (DES) in SVD patients.
RESTORE ISR China Trial: This trial involved 240 subjects across 12 sites in China, focusing on patients with significant in-stent restenosis. The primary endpoint was in-segment late lumen loss at 9 months, with RESTORE showing statistically similar rates to the best-in-class drug-coated balloons (DCB).
RESTORE SVD China Trial: Conducted with 262 subjects, this trial demonstrated RESTORE as a non-inferior alternative to zotarolimus-eluting stents for small vessel lesions, with no significant difference in target lesion failure rates over 12 months.
Technical Specifications: The catheter features a drug-releasing balloon with a polyamide blend material, a 140 cm usable length, and a paclitaxel coating of 3.0 μg/mm². It is compatible with a 5F guiding catheter and has a rated burst pressure of 16 bar.
Indications: RESTORE® is indicated for treating coronary in-stent restenosis, small vessel lesions, side branch dilation of bifurcated coronary artery lesions, and de-novo lesion dilation.
Advantages: The device offers excellent maneuverability, enhanced crossability, and trackability, with minimal risk of embolization due to its stable coating and low surface friction.
Ordering Information: The balloon catheter is available in various diameters (2.00 mm to 4.00 mm) and lengths (15 mm to 30 mm).
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Catalog excerpts

restore® deb-1

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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restore® deb-2

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® deb-3

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 evaluated...

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restore® deb-4

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 homogeneity...

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restore® deb-5

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 clinical...

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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 Q,...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.