Paclitaxel Releasing Coronary
Balloon Dilatation Catheter


The treatment of the heart requires superior medical device safety with predic-
table clinical efficacy.

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.

‘RESTORE DCB treated arteries show no noticeable coating-
induced micro emboli!’

Pre-clinical study report, CV-PATH Institute,
Gaithersbourg USA, Medical Director Renu Virmani MD

Safe Drug Coating Technology
for advanced treatment quality.

SAFEPAX. 0.1µm unsurpassed small PTX
particulates protect from micro-

RESTORE ‘SAFEPAX’ technology utilizes the clinically important, stable nanocrystalline PTX drug-coating. RESTORE ‘SAFEPAX’ coating is a 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.

Microscopy of the LEGFLOW DCB balloon surface
showing no visible PTX particulates

Minimizing the risk of micro-embolization.

RESTORE DCB ‘SAFEPAX’ technology provides maximum protection from downstream effects to minimize the risk potential of miocardial vascular changes. The biological ‘SAFEPAX’ drug release matrix avoids the side effects of plasticizer or contrast media drug excipients. Coronary artery treatment requires the highest degree of patient safety. The protection from necrosis in arterial tissue to minimize the risk potential of late coroanry aneurysm, and minimizing the risk of micro embolization to avoid myocardial damage, caused by vascular changes.

‘Stable’ vs. ‘unstable’ DEB PTX coating

When invisibility equals safety!

1. RESTORE DCB PTX coating of non visibly small 0.1µm PTX particulates appear as safe as POBA.

2. Other DCBs with ‘unstable’ and brittle balloon coatings, consisting of large 2.0µm-3.0µm (visible) PTX crystals, bear a risk for the physician and patients.

About Safepax

No need of an extra insertion tool. The RESTORE coating integrity. A step beyond.

The indestructible, structural balloon coating integrity, combined with a protective drug coating finesse, does not require the use of an extra insertion tool.

The RESTORE Paclitaxel balloon surface coating cannot be wiped or fall off the balloon during catheter preparation, insertion or manipulation. RESTORE prevents endangerment of cathlab personnel, and guarantees a safe and predictable drug delivery to the target lesion site.

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.

RESTORE clinical study results on in-stent restenosis.
High clinical efficacy.* Efficacy and Safety of Paclitaxel-Coated Balloon
for the Treatment of In-Stent Restenosis in High-Risk Patients:
an experience with angiographic follow up.

Total restenosis incidence and restenosis incidence per subgroups:

*Efficacy and Safety of Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis in High-Risk Patients, published in ‘The American Journal of Cardiology’, Vol. 116, Issue 11

Marco Miglionico, MD, Annunziata Nusca, MD, PhD, Domenico Scordino, MD, Paolo Gallo, MD, PhD, Fabio Mangiacapra, MD, PhD, M. Campanale, MD, Andrea D‘Ambrosio, MD, Giuseppe Patti, MD, Germano Di Sciascio, MD. Department of Cardiovascular Sciences, Campus Bio-Medico University, Rome, Italy.

Detailed information on request at Cardionovum.

Cardionovum clinical program of RESTORE Paclitaxel releasing coronary balloon dilatation catheter.

1. Randomized controlled single center clinical study.
82 patients, comparison of Restore DCB vs Panthera Lux vs In.Pact Falcon. Status completed.
Detailed information on request at Cardionovum.