Paclitaxel Releasing Coronary
Balloon Dilatation Catheter
High patient safety and revascularization efficacy.
For the successful prevention and treatment of coronary restenosis.
Restore demonstrates an unparalleled product finish, which retains Paclitaxel in its balloon surface matrix coating. A premature debonding of the Paclitaxel during catheter manipulation and the risk of unintentional cath lab contamination is thereby eliminated.
1. Coronary In-Stent restenosis
2. RESTORE DCB dilatation of in-stent restenosis
3. RESTORE DCB dilatation of small coronary arteries (ø < 2.3 mm) and bifurcated sidebranch lesions.
4. RESTORE DCB optimizes coronary stenting results.
Proven! Optimal therapeutic drug-in-tissue bioavailability resulting
in maximal clinical efficacy.
No signs of vessel toxicity were found. No other safety concerns were noted in animals studied for up to 90 days.*
RESTORE DCB drug-in-tissue bioavailability.
A short-term balloon-to-vessel wall contact time of 45 sec. is sufficient to inhibit SMC proliferation sustainably for up to 150 hours.
Pre-clinical results confirm no noticeable embolization results similar to POBA. Pre-clinical study results confirm a most effective drug delivery into the vascular tissue, showing a sustained drug effect of up to 28 days. ‘Cardionovum’s DEB shows great effectiveness in neo-intimal growth reduction in diseased vessels.’
*Source: Report on pre-clinical studies performed
RESTORE SAFEPAX performance. Effective DCB PTX drug-transfer.
Consistent and predictable drug delivery to the artery lesion site results in a homogenous and maximized drug absorption into the arterial tissue.
Only the smallest PTX crystals appear safe enough to bear no risk of adverse embolic or thrombotic effects or obstructing the smaller distal vasculature. RESTORE ensures a high patient safety by non-visible 0.1µm smallest PTX particles leapfrogging ahead of 2.0-3.0µm large Paclitaxel crystals on most other DCBs.