Magic Touch sirolimus-coated balloon: animal and clinical evidence of a coronary sirolimus drug-coated balloon

Abstract

The Magic Touch sirolimus-coated balloon (SCB) was recently introduced in Europe and features robust clinical technology different from other devices on the market. This device is able to deliver a sufficient sirolimus dose to the target segment to reduce neointimal proliferation with very little exposure downstream and no apparent adverse effects at sustained high drug concentrations. The SCB represents a promising novelty within the drug-coated balloon arena due to its mid-term efficacy and safety in the treatment of coronary artery disease, especially in de novo and small-vessel coronary lesions. The purpose of this article is to provide an up-to-date overview of the currently available animal and clinical trial results, as well as to highlight ongoing trials on the Magic Touch SCB.

TWEETABLE ABSTRACT

Among modern drug-coated balloons, Magic Touch features Nanolutè technology, which allows effective and rapid sirolimus release and retention for 8–12 weeks. Previous and ongoing trials are showing good clinical performance with sustained safety.

GRAPHICAL ABSTRACT

In the EASTBOURNE section of the graphical abstract, the statistical data, including numbers and percentages, were taken from the EASTBOURNE trial [1] to create the graphs.

Article Highlights

Background

• The development of drug-coated balloons (DCBs) has improved the management of coronary artery disease (CAD), the leading cause of death worldwide.

• The Magic Touch Sirolimus DCB was recently introduced in Europe and features Nanolutè technology to deliver sirolimus to the vessel wall, ensuring that it is sustained for the duration required to achieve therapeutic effects.

• The objective of this review is to provide an up-to-date overview and summary of the most recent animal and clinical trial data on the Magic Touch sirolimus DCB, as well as to highlight ongoing investigations analyzing the role of this sirolimus-coated balloon (SCB) in various clinical settings.

Pre-clinical & clinical data of Magic Touch SCB

• This article demonstrates that the SCB is a promising novelty within the DCB arena due to its mid-term efficacy and safety in the treatment of CAD, particularly in de novo and small-vessel coronary lesions, at least from the Magic Touch perspective, as the other two SCBs on the market lack clinical evidence.

• In addition, preclinical studies have demonstrated that this device is capable of delivering sirolimus to the target segment in a sufficient amount to reduce neointima proliferation in a vascular model with minimal exposure to downstream organs, with no apparent adverse effects when sustained high drug concentrations in the target vessel are maintained.

Conclusion

• In conclusion, SCBs represent a new option in the treatment of CAD, especially in patients with in-stent restenosis, de novo artery disease, and small coronary arteries, in addition to a few well-known and effective paclitaxel-coated balloons. Currently, ongoing trials will have to clarify the performance of this device compared with drug-eluting stents.

Keywords: :

• de novo coronary artery disease
• drug-coated balloon
• ISR
• sirolimus DCB
• sirolimus-coated balloon

Financial disclosure

B Cortese serves as an Advisory Board member for Concept Medical and ANT, and as a Consultant for Concept Medical, ANT, Medtronic, Medalliance, Cordis, BBraun, Innova HTS, and AR Baltic. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Competing interests disclosure

The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Writing disclosure

No writing assistance was utilized in the production of this manuscript.