RESTORE® PLUS
Paclitaxel Releasing PTCA
Balloon Catheter
Specifically designed for the treatment of the most COMPLEX LESIONS and TORTUOUS ANATOMIES
Dott. Ielasi (Milan, Italy) speaks to Radcliffe at EuroPCR 2024 congress held in Paris (France) about the results of the Hyper Study 2-years Follow-up.
In this video interview, Dr. Ielasi explains the technology behind the Restore® drug-coated balloon (Cardionovum®) and its advantages. Furthermore, he offers a comprehensive analysis of the HYPER Study, elucidating its methodology, participant selection criteria, and clinical outcomes.
Specifically, the 1-year outcomes revealed that DoCE was 3.7%. Subsequently, an extensive 2-year follow-up demonstrated a DoCE rate of 4.6%, maintaining stability up to the 3-year analysis.
In conclusion, the HYPER Study demonstrated that the hybrid approach combining a drug eluting stent with the Restore® DEB is not only feasible but also associated with very high procedural success and a remarkably low 1-year DoCE rate. These favourable results remain consistent over the 3-year follow-up period.
Dr. Changdong Guan from China presents 4-year clinical outcomes of the RESTORE SVD randomized trial.
Drug-coated balloon versus drug-eluting stent for the treatment of small-vessel disease.
EFFORTLESS NAVIGATION, MORE SIZES:
REDEFINING DCB ACCESSIBILITY.
RESTORE® PLUS
Paclitaxel Coronary DCB powered by clinically proven with Safepax® coating technology
- In-Stent Restenosis;
- Small Vessel Disease;
- Diffuse Long Lesions and Bifurcations.
Designed with a New Platform that improves the delivery performances
RESTORE® PLUS: MORE NAVIGABILITY WITHOUT COMPROMISING EFFICACY.
- No distal embolization thanks to No flacking effect for the treatment of the most fragile patients;
- No Reflow and No Slow Flow phenomena;
- Lowest Wash-Off effect among contemporaneous DCBs ensuring the optimal therapeutic treatment;
- Highest deliverability for an unmatched navigability,even in the most complex and distal districts;
- Safety and Efficacy clinically proven on thousands of patients including RCTs* with F.U. up to 5 years.
CLINICAL EVIDENCES
RESTORE SVD Randomized Clinical Trial Results
RESTORE® DEB vs RESOLUTE™ DES in De-Novo small and Very Small Vessels (VSV).
Data from 230 patients showed that:
- At 9 months RESTORE® DEB showed to be non-inferior to RESOLUTE™ DES in terms of in-segment % Diameter Stenosis1;
- 5-year data confirmed that RESTORE® DEB has equivalent long-term safety and efficacy compared to RESOLUTE™ DES in De-Novo small and VSV2.
RESTORE ISR Randomized Clinical Trial Results
RESTORE® DEB vs SeQuent® Please in the treatment of In-Stent Restenosis (ISR).
Data from 230 patients revealed that:
- At 9 months, RESTORE® DEB was non-inferior to SeQuent® Please in terms of Late Lumen Loss in the treatment of ISR3;
- At 2 years, both groups had similar Target Lesion Failure (TLF)4: 14,8% vs 15.0%; p=ns.
References
- Tang Y, et al., Drug-Coated Balloon Versus Drug-Eluting Stent for Small- Vessel Disease: The RESTORE SVD China Randomized Trial. JACC Cardiovasc Interv. 2018 Dec 10;11(23):2381-2392;
- Shao Liang Chen, Data presented at TCT 2022;
- Chen Y, et al., “Comparison of 2 Different Drug-Coated Balloons in In-Stent Restenosis: The RESTORE ISR China Randomized Trial. JACC Cardiovasc Interv. 2018 Dec 10;11(23):2368-2377;
- Cai X, et al., Comparing the efficacy and safety of two different drug-coated balloons in in-stent restenosis: Two-year clinical outcomes of the RESTORE ISR China randomized trial. J Cardiol. 2023 Jan;81(1):76-82.
Safe Drug Coating Technology
for advanced treatment quality.
SAFEPAX®. with the unsurpassed non-crystalline coating and no PTX particulates protect from micro- embolization.
RESTORE® PLUS ‘SAFEPAX®’ technology utilizes the clinically important, stable amorphous PTX drug-coating. RESTORE® PLUS ‘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 RESTORE® PLUS DCB balloon surface
showing no visible PTX particulates
Minimizing the risk of micro-embolization.
RESTORE® PLUS 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!
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Homogeneous surface composed of smooth amorphous coating:
'stable solution’ of PTX /Ammonium Salt excipient - Balloon surface coated with white powder of brittle crystalline PTX + excipients
