Paclitaxel Releasing Coronary
Balloon Dilatation Catheter
Dr. Alfonso Ielasi from Italy presents HYPER Registry.
Hybrid treatment approach combining RESTORE drug coated balloon with new generation drug eluting stent in diffuse CAD.
Lesions longer than 28mm
75 patients, 100% enrolment completed.
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.
RESTORE ensures a high patient safety by non-crystalline coating ahead of 2.0-3.0µm large brittle Paclitaxel crystals on most other DCBs.
- Controlled trials confirm the excellent Procedural success rates >98% in both ISR and SVD patients1 3
- No procedure-related complications with RESTORE in two ISR trials and 160 patients: <1% complication rates1 3
- Similar complication rates to DES in vulnerable SVD patients (p=0.19 for comparison)2
- Only DCB with demonstrated low complication rates (~3%) in patients with very small vessels2
- Miglionlco M, Manglacapra F, Nusca A, et al. Efficacy and Safety of Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis In High-Risk Patients. Am J Cardiol 2016; 116: 1690-4.
- Tang Y, Qlao S, Su X, Chen Y, Jin Z, Chen H, Xu B, Kong X, Pang W, Liu Y, Yu Z, Li X, Li H, Zhao Y, Wang Y, Li W, Tian J, Guan C, Xu B, Gao R, for the RESTORE SVD China ln119stlgators, Drug-Coated Balloon Versus Drug-Eluting Stent for Small Vessel Disease: The RESTORE SVD China Randomized Trial, JACC: Cardiovacular Interventions (2018), doi: https://dol.org/10.1016/j.jcin.2018.09.009.
- Chen Y, Gao L, Qin Q, Chen S, Zhang J, Chen H, Wang L. Jin Z. Zheng Y, Zhang Z, Li H, Li X, Fu G, Chen L, Sun Z, Wang Y, Jin Q, Cao F, Guo J, Zhao Y, Guan C, Li W, Xu B, for the RESTORE ISR China Investigators, Comparison of Two Different Drug-Coated Balbons in In- Stent Restenosis: The RESTORE ISR China Randomized Trial, JACC: Cardiovacular Interventions (2018), doi: https://doi.org/10.1016/J.jcin.2018.09.010.