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Drug-Coated Balloon

Do you have the optimal treatment options available to treat your ISR patients? Drug-coated balloons (DCBs), when approved, will offer targeted antiproliferative drug delivery to the lesion designed to reduce the rate of restenosis without introducing an additional metallic layer.

CAUTION: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.

What is ISR?

A burden for interventional cardiologists

ISR is a re-narrowing or blockage of the coronary arteries that comes back following treatment with a stent.¹

Potential mechanical or technical factors associated with ISR include stent under sizing, stent underexpansion, vessel calcification, stent fracture, and geographic miss. Biological mechanisms of ISR include neointimal hyperplasia and neoatherosclerosis.² 

Numerous treatment options exist to address ISR, but treatment selection should address the underlying cause of the ISR, otherwise repeat ISR is more likely to occur.²


Do your ISR treatment options need to expand? 

Challenges with ISR realities

Current ISR treatment practices include the insertion and layering of additional stents, repeat balloon angioplasty, CABG, or brachytherapy, all of which may introduce potential risks for patients. The majority of ISR PCI procedures in the United States are currently treated with another stent (82.7%).³ Unfortunately, multiple metallic stent layers are associated with a progressively higher risk of recurrent ISR and negative clinical outcomes.⁴ ⁵

Need of reintervention after first and recurrent in-stent restenosis chart

The bars show an increasingly higher risk of reintervention as the number of recurrences of in-stent restenosis increases.

Data are based on the incidence of target lesion reintervention in a cohort of 30,440 patients who underwent initial stenting of 48,890 de novo lesions in native coronary vessels during a 15-year period (2002 to 2016) in 2 cardiology centers of the Technische Universität München, Munich, Germany.⁷

The type of initially implanted stent was a newer-generation drug-eluting stent in 70% of the lesions, an earlier-generation drug-eluting stent in 16% of the lesions, a bare-metal stent in 12% of the lesions, and a bioreabsorbable scaffold in 2% of the lesions.



With no permanent implant, a drug-coated balloon reduces thrombotic risk and can shorten the duration of dual antiplatelet therapy.⁶ 

Although DCBs are not currently available in the US, the European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) Guide give DCBs a class I indication for the treatment of ISR.


How do Drug-Coated Balloons (DCB) compare to Drug-Eluting Stents (DES) when treating ISR?

Confronting treatment complexities​

DCBs present an advantage when compared to bare-metal stents and drug-eluting stents in that they do not introduce an additional metal layer that may cause potential complications (including fracture, malposition, and thrombosis).⁵

DCBs may provide a viable alternative therapy for patients who would benefit from shorter DAPT compared to the limitations offered by DES (e.g. <3-month DAPT is only approved for patients who are at high risk of bleeding). Only one month of DAPT was required with the AGENT DCB in the AGENT IDE trial.

Treatment with a DCB may also be beneficial in challenging coronary anatomy such as bifurcations, stenoses, small vessel disease, and other contraindications to stenting, but further study of DCBs in these populations is needed.⁶ ⁷