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The AGENT™ Paclitaxel-Coated balloon catheter, built on the Emerge™ PTCA Balloon Catheter for exceptional deliverabilityr, is indicated for Percutaneous Transluminal Coronary Angioplasty (PTCA) in the coronary arteries to treat in-stent restenosis (ISR) and de novo / small vessel disease.
Optimal dose of 2µg/mm2 compared to 3µg/mm2 of market leading DCBs efficiently achieves sustained benefits of Paclitaxel2 over time.
The TransPax coating is a proprietary formulation of Paclitaxel and a citrate ester excipient (acetyl tributyl citrate – ATBC). It leverages Boston Scientific’s history and expertise with paclitaxel and drug coating.
Boston Scientific’s TransPax™ is the coating on both IC and PI Drug-coated balloons (DCB). Ranger™ Paclitaxel-Coated PTA Balloon Catheter is Boston Scientific's DCB for Peripheral Interventions.
AGENT™ Drug-Coated Balloon is built on the Emerge™ balloon catheter technology which combines the best of Boston Scientific balloon technologies to offer exceptional deliverability5 with an ultra-low tip profile and is designed to navigate and cross even the most challenging lesions with unprecedented ease.
Once the DCB has been deployed, the durable TransPax coating:
1. Ensures that a consistent drug dose is delivered to a lesion*
2. Binds with microtubules to inhibit proliferation of smooth-muscle cells*
3. Enables healing by selectively impacting cells that cause restenosis while allowing healing of endothelial cells*
Enhanced Coating Integrity*
Designed to improve coating durability and drug transfer efficacy, allowing for a lower dosage of Paclitaxel*
Optimized Drug Transfer°
Balanced hydrophobic and hydrophilic properties allow efficient drug transfer to the vessel wall
Minimized Systemic Loss§
Less particulates and systemic loss while optimizing arterial tissue Paclitaxel levels.
* Drug coating designed to deliver therapeutic drug dose in association with balloon angioplasty treatment. Data on file at Boston Scientific.
° Data on file at Boston Scientific. Pre-clinical results may not be necessarily indicative of clinical outcomes.
§ Bench testing performed by Boston Scientific. Results not necessarily indicative of clinical performance.
† Data on file at Boston Scientific. Pre-clinical results may not be necessarily indicative of clinical outcomes. Hemoteq Coating Process Validation by HPLC. Data on file at Hemoteq.
‡ 3 μg/mm2 dose for both B Braun SeQuent Please and Biotronik Pantera Lux per manufacturer’s website.
§Method: balloons delivered in a coronary track model with fluid recirculation of 150 ml/min at T = 37 ˚C. Particulates are collected with a polycarbonate filter 5.0 μm x 47 mm (Sterilitech).
Bench test results may not necessarily be indicative of clinical performance.