Paclitaxel Coated-PTCA Ballon Catheter

TransPax™ DCB Coating Efficacy study2 by Dr. Granada

• For this research, Dr. Juan Granada used a familial hypercholesterolemic swine model (Rapacz), and caused injury leading to the occurrence of in‐stent restenosis.
• 14 days following that injury, the swine was treated with a with a TransPax balloon, a Medtronic In.Pact™ DCB, a Bard Lutonix™ DCB and POBA, and Boston Scientific’s Sterling™ PTA balloon.
• Angiography was captured pre‐injury, at treatment, and 28 days post-treatment.

• All tested Drug-Coated Balloon demonstrated efficacy (decreased NI thickness and percent stenosis) compared to Control POBA2
• There were no statistical differences between Drug-Coated Balloon types2
• Result support clinical efficacy of TransPax™ coating2

Presence of Paclitaxel (PTx) Post AGENT™ Treatment4 by CVPath Institute

• CVPath performed the Boston Scientific DCB Paclitaxel staining analysis.
• Demonstrates drug transfer and drug distribution post Agent treatment in a rabbit model, using confocal microscopy to assess paclitaxel distribution after treatment by AGENT DCB.
• Endothelialization is recovering from complete absence 15 minutes after DCB deployment to 14 days, where presence of CD31 positive cell junctions is observed4.
Paclitaxel-positive staining of arteries post-DCB deployment
Presence of Paclitaxel from 15 minutes to 14 days post balloon deployment
15 Minutes1 Day3 Days7 Days14 Days

AGENT DCB: Drug efficiently into the vessel’s wall

• Boston Scientific's TransPax coating has sustained drug effect:
  - This animal model investigated the efficacy of drug delivery after deployment of drugcoated balloons using the TransPax paclitaxel coating system
  - Simultaneous staining for CD31 and paclitaxel were successfully used to co-localize drug in relation to endothelial cells and to characterize dynamic changes in localization over time during healing
  - CD31 expression by endothelial cells was lowest at 15 minutes (2.86 mm2) and increased up to 14 days (57.04 mm2). This showed the healing process