VIRTUALLY LOSS-LESS MATRIX FOR IMPROVED HOMOGENEITY OF DRUG TRANSFER AND HIGHEST COATING STABILITY ON THE MARKET*
* Cardionovum data on file
When invisibility equals safety!
‘Stable’ vs. ‘unstable’ DCB PTX coating.
- Homogeneous surface composed of smooth amorphous coating: 'solid solution’ of PTX /Ammonium Salt excipient
- Balloon surface coated with white powder of brittle crystalline
PTX + excipients
Microscopy of the ‘SAFEPAX’ balloon surface
showing no visible PTX particulates.
Minimizing the risk of thrombotic effect.
SAFEPAX® the 3rd generation unique paclitaxel matrix system, with Lipophilic and Polymeric excipient to minimize wash off rate and prevent drug crystallization on the balloon's surface incorporates PTX drug in a homogeneous non-crystalline coating.
No drug coating pitfalls but only high performance.
SAFEPAX provides superior patient results!
drug coating features:
SAFEPAX COATING INTEGRITY:
Stable, elastic polymeric and lipophilic coating with low surface friction for easy handling. After crossing the hemostatic valve, no coating debris are observed at microscope*, no loading tool is required.
- No safety issues with Cardionovum DCBs in clinical trials and registries to date.
- SAFEPAX ® has the highest coating stability (Paclitaxel loss during handling & wash-off) of DCBs without compromising performance.*
- In blood simulated test, Cardionovum DCBs demonstrated high coating stability and minimal particulate loss.*
Consistent and predictable drug delivery to the artery lesion site results in a homogenous and maximized drug absorption into the arterial tissue.
THE UNIQUE SAFEPAX INNOVATION:
The step beyond contemporary first and second generation DCB coatings which had to compromise on vulnerable balloon coating mixtures out of a high water soluble drug excipient with relatively large PTX crystals.