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AGENT is the most PROVEN and STUDIED coronary DCB in the U.S.1
AGENT has been rigorously evaluated across IDE and real-world settings, demonstrating proven outcomes in complex patient populations.
With long-term and real-world evidence at an unmatched scale, AGENT is the most proven coronary DCB in the U.S., delivering the right drug with the right design.
Superior
The FIRST and ONLY U.S. IDE trial with primary endpoint results confirming statistical superiority to BA,2 with consistent results observed over 3 years.3
Safe
Excellent real-world safety data from over 12,000 patients with in-hospital safety outcomes comparable to DES patients.1
Studied
Extensively studied in over 16,000 patients globally, including complex ISR and de novo patients.4
Superior
Proven clinical performance with statistical superiority to balloon angioplasty in the AGENT IDE Trial.2
AGENT has long-term proven performance with consistent results observed over 3-years in AGENT IDE trial. Showing significantly lower rates of TLF: a 28% relative risk reduction at 3-years (P=0.02).3
1 YEAR
41%
relative risk reduction for TLF (P=0.003)
1 YEAR
50%
risk reduction for TLR (P=0.0005)
1 YEAR
49%
risk reduction in TV-MI (P=0.023)
1 YEAR
0%
definite/ probable ST (P=0.0004)
Not all ISR trials study the same patients.
AGENT DCB demonstrated consistent outcomes in a large, complex patient population reflective of everyday practice.
Safe
Real-world safety comparable to DES proven at scale
Data from over 12,000 real-world U.S. AGENT DCB patients show in-hospital safety outcomes comparable to Drug-Eluting Stent (DES) patients.**1
*27.2% of AGENT DCB use (3,459/12,729 procedures) through June 2025 was for an off-label indication. These findings are presented for scientific discussion only. Please refer to the Instructions for Use (IFU) or product labeling for approved indications and usage.
**AGENT DCB n = 9,269 and DES n = 65,890.
Studied
How much real-world data is there?
AGENT DCB has been used in more than 275,000 patients worldwide and studied in more than 16,000 patients across complex in-stent restenosis (ISR) and de novo populations.4 In a real-world setting, AGENT has been studied in over 12,000 U.S. patients.1
US real-world patients studied6
Right drug
The right drug. The right delivery method.
Built on the proven power of paclitaxel, AGENT DCB has a hydrophobic formulation that supports targeted transfer minimizing drug loss during delivery and treatment. AGENT's penetrating crystalline structure and lipophilic properties also promote rapid drug embedding, absorption and early and late retention in tissue.
Before treatment even begins, does the drug survive the trip?
Drug delivery begins before inflation. In tracking models, AGENT maintained coating during delivery, while Selution SLR demonstrated visible coating loss prior to device inflation.9
Examine DCB drug coating durability post-tracking, pre-inflation*
SELUTION SLR™ DEB
Sirolimus Drug
AGENT™ DCB
Paclitaxel Drug
*Each device was evaluated individually using an aqueous downstream bench model simulating physiological flow. Pre‑tracking shows coating before use; post‑tracking shows devices after simulated catheter tracking, prior to inflation. Bench Test results may not necessarily be indicative of clinical performance. The testing was performed by Boston Scientific. Data on file.
AGENT DCB demonstrated superior drug retention compared to Selution SLR DEB
In a pharmacokinetic pre-clinical study10 comparing AGENT DCB with paclitaxel to Selution SLR DEB with sirolimus, AGENT delivered high acute transfer with sustained coronary-tissue retention out to 120 days, whereas Selution had no available drug in tissue at 90 and 120 days.
*A single extraction method was used to obtain available drug from tissue using acetonitrile (PTX) or methanol (sirolimus).
Right design
Designed to reach and treat challenging ISR
AGENT'S low profile-tip and flexible design are engineered to deliver drug therapy where it matters most, supporting consistent drug transfer in challenging ISR lesions.11
Lower tip profile
Lower entry profile (inches)
LOWER IS BETTER
More flexible
Distal end flexibility (gf-cm)
LOWER IS BETTER
Less track force
Max radial track force (g)
LOWER IS BETTER
AGENT DCB is the only coronary DCB with both NTAP and TPT reimbursement programs available12,13
AGENT™ Drug-Coated Balloon (DCB) is supported by established coding for appropriate U.S. reimbursement programs across inpatient, outpatient, and physician settings. As the only coronary DCB with both NTAP and TPT reimbursement programs available, AGENT helps expand patient access to DCB treatment options.
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REFERENCES
- Lalani C, Secemsky E, Song Y, et al. Use of Paclitaxel-coated balloons in the United States: Early results from the Agent Post approval study. Circulation: Cardiovascular Interventions. Published online May 12, 2026. doi:10.1161/circinterventions.126.016625
- Yeh RW, Shlofmitz R, Moses J, et al. Paclitaxel‑Coated Balloon vs Uncoated Balloon for Coronary In‑Stent Restenosis: The AGENT IDE Randomized Clinical Trial. JAMA. 2024;331(12):1015–1024. doi:10.1001/jama.2024.136
- AGENT IDE Clinical Trial 3-year data presented at CRT 2026 by Dr. Robert Yeh.
- Market data on file at BSC as of January 2025.
- Cutlip DE, Mehran R, Sharma S, et al. Sirolimus‑eluting balloon vs repeat drug‑eluting stent or balloon angioplasty for coronary in‑stent restenosis. J Am Coll Cardiol. 2026. SELUTION4ISR Trial.
- Data on https://cordis.na/clinical-info/drug-eluting-balloons-clinical-trials as of April 2026.
- The Business Research Company - Drug-Coated Balloons Global Market Report: https://www.thebusinessresearchcompany.com/report/drug-coated-balloons-global-market-report
- Sedhorn R, et al. JACC Cardiovasc Interv. 2024;17(13):1533-1543
- Data on file at Boston Scientific.
- Long-term coronary tissue retention of paclitaxel vs sirolimus from drug-coated balloons: a comparative pharmacokinetic study. JACC Cardiovasc Interv. 2026;19(5 Suppl):S17. doi:10.1016/j.jcin.2026.01.054
- DCB Bench testing performed by Boston Scientific Corporation. Data on file at Boston Scientific. Tip profile and max radial track force data on file for 3.00 mm DCBs. Distal end flexibility, tip flexibility and distal bond profile data on file for 3.50 mm DCBs excluding Selution, data on file for 3.00 mm DCB.
- Medicare Hospital Inpatient Prospective Payment System (IPPS) Final Rule; CMS-1833-F; p. 610; https://www.federalregister.gov/d/2025-14681.
- Medicare Hospital Outpatient Prospective Payment System (OPPS) Final Rule; CMS-1834-FC; p. 188; https://www.federalregister.gov/d/2025-20907