AGENT™

ISR treatment and the need for innovation

Approximately 10% of PCIs are performed to treat in-stent restenosis (ISR). Current treatment options for ISR include layering of additional stents, balloon angioplasty, radiation, all of which introduce potential risks for patients.

There is a need for technology that can provide a better option for patients. AGENT DCB provides a targeted therapeutic dose of Paclitaxel to the lesion without introducing an additional metallic layer.

The AGENT DCB technology was granted Breakthrough Device designation by FDA, a status intended to provide patients more timely access to novel devices that may provide a substantial improvement over existing therapies.²

Globally, DCBs are an established therapy for ISR

Coronary DCBs have been used to treat over one million patients globally.³

The ESC/EACTS Guidelines⁴ assign DCBs a class I indication for the treatment of ISR, meaning DCB is recommended and there is sufficient evidence and/or general agreement that a DCB is beneficial, useful, and effective. The guidelines also give DCB for ISR an "A level of evidence" meaning there are multiple RCTs or meta-analyses.

The AGENT Drug-Coated Balloon is commercially available in many international markets, including Europe, parts of Asia Pacific and Latin America, and has been used to treat over 100,000 patients. 

More than 4,400 patients have participated in AGENT Drug-Coated Balloon clinical trials, spanning a wide spectrum of lesion types such as ISR, small vessel, de novo, and bifurcations. 

AGENT IDE clinical data is foundational

The AGENT Investigational Device Exemption (IDE) trial evaluated the safety and effectiveness of the AGENT Drug-Coated Balloon compared to balloon angioplasty in patients with in-stent restenosis.

Primary endpoint met: AGENT demonstrated statistical superiority to balloon angioplasty in the AGENT IDE Trial.