BioStream

BioStream

BioStream

Product catalog summary
Introduction
The document discusses the BioStream™ paclitaxel-eluting balloon catheter, a medical device used for coronary interventions, specifically targeting in-stent restenosis. It highlights the device's design, efficacy, and application in clinical settings.

Specifications
The BioStream catheter features a 1:1 mixture of paclitaxel (3 μg/mm²) and shellac coating, designed to deliver paclitaxel locally to arterial tissue. It is available in various balloon diameters (2.0 to 4.0 mm) and lengths (15 to 30 mm), with a usable catheter length of 140 cm. The recommended guide wire is 0.014”.

Procedures
The catheter is advanced to the lesion site, where balloon inflation at 8 bar for at least 30 seconds facilitates paclitaxel delivery through cracked plaque onto the vessel wall. The inflation time is critical for optimal tissue concentration, with 45 seconds being optimal based on porcine artery studies.

Clinical Efficacy
Clinical trials, including the Valentines I trial and a Spanish registry, demonstrate the catheter's efficacy in reducing in-stent restenosis. The device shows significant reduction in recurrent restenosis and offers excellent pushability, trackability, and crossability.

Recommendations
The BioStream catheter is recommended for patients with discrete coronary artery lesions with a reference vessel diameter of 1.50 to 4.00 mm. It is particularly indicated for treating coronary in-stent restenosis.

Safety and Regulatory Information
The device is CE Mark approved and restricted to sale by or on the order of a physician. It is not available for sale in the United States and certain other countries. The product labeling includes indications, contraindications, warnings, and instructions for use.

Conclusion
The BioStream paclitaxel-eluting balloon catheter is a well-designed device for coronary interventions, offering effective drug delivery and reduced restenosis rates. Its design and clinical performance make it a suitable choice for treating in-stent restenosis.
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Catalog excerpts

BioStream-1

Evidence-driven medicine Anti-restenosis treatment Optimization for safety and ecacy PACLITAXEL ELUTING PTCA BALLOON CATHETER Latest generation paclitaxel-eluting balloon for coronary interventions In a time-related study conducted in 29 porcine arteries treated with BioStream , paclitaxel optimal arterial tissue concentration was achieved with a balloon ination time of 45 seconds 1. ™ PACLITAXEL ELUTING PTCA BALLOON CATHETER Latest generation paclitaxel-eluting balloon for coronary interventions Ination time-dependent tissue and balloon surface paclitaxel concentrations 45 minutes post-dilatation µM/L 200 Coronary artery tissue paclitaxel concentrations of dilated segments, proximal as well as distal reference Ordering Information Proximal segment Dilated segment Distal segment Coronary artery tissue paclitaxel concentrations of dilated segments, proximal as well as distal reference Proximal segment Dilated segment Distal segment 1. A. Posa et al. Catheterization and Cardiovascular Interventions 76:395–403 (2010). 2. Axel D.L. et al. Circulation 1997; 96:636-45). 3. Vaquerizo B. et al. Insights from Spanish Multicenter Registry, Journal of Interventional Cardiology 2011, 24(6): 518-528 Remnant paclitaxel amount on the balloon surface, 4. Stella P.R. et al. e Valentines Trial, EuroIntervention 2011; 7: 705-710 BioStream ™ paclitaxel-eluting balloon catheter is CE Mark approved. Balloon surface remnant paclitaxel CAUTION: e law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. BioStream is a trademark or registered trademark of Biosensors International Group, Ltd. All cited trademarks are the property of their respective owners. Les informations relatives à ce produit ne sont pas destinées aux professionnels de santé exerçant en France – Any information related to this product is not intended for health care professionals who practice in France. Proven ecacy in in-stent restenosis Spanish registry : LLL = 0.31±0.28 mm 3 In-stent restenosis Sample size Valentines I trial In-stent restenosis BMS DES Non-diabetic Diabetic Total number of patients* Not available for sale in the United States and certain other countries. © 2013 Biosensors International Group, Ltd. All rights reserved. Sample size Denite stent TLR (%) thrombosis (%) at 8 months *Valentines I trial evaluated the drug-eluting balloon catheter in patients with ISR BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE LTD

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BioStream-2

e right choice Delivering the paclitaxel drug e treatment process With balloon dilatation, the injuries to the arterial wall initiate an inammatory reaction with an excretion of growth factors which trigger the onset of cell division and smooth muscle cell migration. Paclitaxel prevents restenosis by stabilizing microtubal formation and thus prevents the cells going through the phases of replication, resulting in the inhibition of cell division. Paclitaxel reduces the excretion of the platelet-derived growth factor (PDGF) that mediates vascular smooth muscle cell migration to the intima2. e BioStream...

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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.