BioFreedom

BioFreedom

BioFreedom

Product catalog summary
Introduction
The document discusses the BioFreedom™ drug-coated stent, highlighting its unique features and clinical benefits. It is the world's first polymer-free stent with Biolimus A9 (BA9) and is CE Mark approved.

Specifications and Features
BioFreedom™ combines the advantages of Drug Eluting Stents (DES) and Bare Metal Stents (BMS). It delivers anti-restenotic therapy with Biolimus A9, potentially reducing the duration of Dual Anti-Platelet Therapy (DAPT). The stent releases BA9 directly from the abluminal surface, with 98% transferred within 28 days, leaving the stent to function like a BMS.

Innovative Technology
The stent features a micro-structured surface treatment (SMS) and uses BA9, a drug with increased lipophilic properties for effective local action on vascular smooth muscle cells. This innovation allows for controlled drug release without a polymer carrier.

Clinical Evidence
BioFreedom™ has demonstrated non-inferiority to Taxus® Liberté® in clinical studies, with a median late lumen loss (LLL) of 0.17 mm compared to 0.35 mm for Taxus®. The stent's efficacy and safety are supported by data from the BioFreedom First in Man study.

Ordering Information
The document provides a detailed table of ordering information, listing stent lengths and diameters with corresponding product codes.

Conclusion
BioFreedom™ represents a significant advancement in stent technology, offering effective drug delivery and reduced systemic exposure, expanding therapeutic options for physicians.
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Catalog excerpts

BioFreedom-1

e world’s rst polymer-free stent with BA9 ™ e world’s rst polymer-free stent with BA9 ™ Ordering Information Stent Length (mm) Stent Diameter (mm) 1. Clinical studies exploring this potential are in progress 2. In vivo data shows that approximately 2% of BA9 remains on the stent after 28 days. Data on le at Biosensors International 3. Adapted from Grube E., oral presentation TCT 2010 BioFreedom™ drug-coated stent is CE Mark approved. 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. BioFreedom, Biolimus A9 and BA9 are trademarks or registered trademarks of Biosensors International Group, Ltd. in the United States and other countries. All cited trademarks are the property of their respective owners. Not available for sale in the United States and certain other countries. © 2013 Biosensors International Group, Ltd. All rights reserved. BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE LTD

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BioFreedom-2

Expanding the therapeutic horizon for physicians Changing the script Drug Eluting Stents (DES) are proven to reduce the risk of restenosis and improve outcomes for patients with more complex coronary disease. However, in certain patients where there is a requirement to avoid prolonged Dual Anti-Platelet erapy (DAPT), Bare Metal Stents (BMS) may be preferred. BioFreedom ™, as a Drug-Coated Stent (DCS), combines the advantages of both DES and BMS. It delivers an eective anti-restenotic therapy with Biolimus A9 ™, and may shorten the required DAPT 1 regime. Increasing safety and ecacy Following...

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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.