RESTORE DEB®
Paclitaxel Releasing Coronary
Balloon Dilatation Catheter
The treatment of the heart requires superior medical device safety with predic-
table clinical efficacy.
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.
Dr. Alfonso Ielasi from Italy presents clinical outcomes HYPER Registry.
Hybrid treatment approach combining RESTORE drug coated balloon with new generation drug eluting stent in diffuse CAD.
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.
Safe Drug Coating Technology
for advanced treatment quality.
SAFEPAX. with the unsurpassed non-crystalline coating and no PTX particulates protect from micro- embolization.
RESTORE ‘SAFEPAX’ technology utilizes the clinically important, stable amorphous 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!
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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
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
References
- 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.
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 Stenosis2;
- 5-year data confirmed that RESTORE® DEB has equivalent long-term safety and efficacy compared to RESOLUTE™ DES in De-Novo small and VSV3.
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 ISR4;
- At 2 years, both groups had similar Target Lesion Failure (TLF)5: 14,8% vs 15.0%; p=ns.
References
- 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, 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.
