Paclitaxel Coated-PTCA Ballon Catheter
AGENT Preclinical Research
Boston Scientific has developed a comprehensive PRECLINICAL PROGRAM to provide strong evidence that supports the safety and performance of AGENT™ Paclitaxel Coated-PTCA Balloon Catheter.
Boston Scientific’s Preclinical program for the TransPax™ coating has been ongoing for over 6 years, involved more than 300 animals, and tested 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.
Results provided a thorough investigation of key technical aspects of the coating, including its mechanism of action, systemic, and vascular effects1.
In total, outcomes of the preclinical program were predictive of performance and a very low risk profile for AGENT in clinical use1,2,3.
- The safety of AGENT was supported by no device-related morbidity or mortality, no occlusive thrombus, or other adverse clinical events1,2.The vascular response to AGENT treatment groups were comparable to the Pantera™ Lux. No risk to patient safety was identified2,4.
- AGENT achieves similar long term paclitaxel levels with a lower paclitaxel dose density compared to Pantera Lux and SeQuent™ Please1,3.
- Increased drug delivery efficiency allows for a steady state of drug level in the tissue during the restenotic cascade, and for reduced downstream particulates4,5,6.