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AGENT™ Drug-Coated Balloon
Reimbursement
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- Overview
- Clinical data
- Technical specifications
- Ordering information
- Training
- Reimbursement
- Resources
FDA approved: An AGENT of change for ISR treatment
AGENT Drug-Coated Balloon expands treatment options for physicians and their patients by delivering a targeted anti-proliferative drug dose, without introducing an extra layer of metal.
How it works
Why choose AGENT Drug-Coated Balloon?
ISR treatment option expansion
~10% of PCIs are complicated by in-stent restenosis (ISR)1. Currently, 82% of patients with ISR receive another stent.2 Yet repeat intervention is associated with a higher risk of target lesion revascularization.3
For patients with ISR, placing additional stents increases risks including thrombosis⁴ and future ISR.⁵ ⁶ Coronary drug-coated balloons (DCBs) provide a proven alternative and have been used to treat more than 1 million patients worldwide.⁷
Comparing DCB to DES when treating ISR
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
Drug-Coated Balloon (DCB)
| Excipient maintains coating integrity, but is less protective than DES Polymer |
| Single high dose transfer of at least 30 seconds |
| No metal left behind |
Drug-Eluting Stent (DES)
| Polymer protects drug during tracking |
| Polymer controls sustained drug release for 90+ days* |
| Permanent presence of stent |
The right drug. The right delivery method.
AGENT is designed with a novel excipient, sharp-edge structure, and uniform crystalline formulation. Its proprietary TransPax™ coating technology optimizes the three phases of drug delivery: transfer, absorption, and retention.
Paclitaxel, the drug used in AGENT and the majority of DCBs worldwide, is better suited for a Coronary DCB Application than Sirolimus:
TransPax™ Coating Technology
With the right balance of hydrophilic and hydrophobic characteristics, our proprietary TransPax Coating Technology is designed to maximize drug transfer to the target vessel wall and delivers the right amount of treatment exactly where it’s needed.
TransPax coating is a combination of:
- Low dose paclitaxel at 2µ/mm2
- Novel excipient Acetyl Tributyl Citrate (ATBC)
- Proprietary manufacturing process
Exceptional deliverability
AGENT reduces time to lesion, which allows for maximized drug tissue concentration and minimized downstream particulates, reducing the risk of embolization. Features include:
Laser Bonded Tip
- Improves crossability and reduces tip catch.
Bi-segment Inner Shaft
- Improves trackability in tortuous distal anatomy
Z-glide™
- Improves tracking with proprietary lubricious coating
TransPax™
- Efficient coating technology
Discover the Modern PCI approach
See the vessel
Assess plaque type and severity using the latest imaging and physiology technology. Eliminate guesswork and make clearer treatment decisions.
Prep the vessel
Successful outcomes start with proper lesion assessment and vessel preparation. Achieve optimal lumen gain with our cutting balloon and rotational atherectomy tools.
Treat the vessel
With our innovative stent portfolio and coronary drug-coated balloon technology, you have access to market-leading therapies that will ensure you are able to improve long-term patient outcomes.
Subscribe for updates on AGENT DCB
Receive timely updates on significant announcements, exclusive opportunities to engage with peers through educational events, and access valuable tools to enhance your ability to assist more patients.
Clinical highlights
2024
AGENT IDE Trial
AGENT IDE is a prospective, multicenter, randomized controlled trial in the United States to evaluate the safety and effectiveness of the AGENT™ DCB compared to balloon angioplasty in patients with in-stent restenosis (ISR).15 At one year, AGENT DCB demonstrated statistically lower event rates15:
AGENT IDE Trial Primary Endpoint16
AGENT DCB showed statistically superior outcomes compared to balloon angioplasty for TLF at 1-year (17.9% versus 28.6% P= 0.003).
TLF relative risk reduction from using AGENT DCB was approximately 41%.
Featured clinical publications
The American College of Cardiology (ACC) Interventional Council
In February 2023, The American College of Cardiology (ACC) Interventional Council released the recommendation that all cardiac cath labs should have imaging capabilities. The review proposes PCI best practices and advocates for broader use of IVI technologies.
RENOVATE-COMPLEX-PCI study
The recent RENOVATE-COMPLEX-PCI study provides evidence in favor of using intravascular imaging-guided PCI to address complex coronary artery lesions. At the 3-year follow-up, intravascular imaging-guided PCI demonstrated a reduced risk of target vessel failure when compared to angiography-guided PCI.¹
Modern PCI clinical data
Discover more clinical data for intravacular ultrasound (IVUS), FFR, and vessel preparation.
Technical specifications
Compliance Chart
| Ballon Length (mm) | |||||||
|---|---|---|---|---|---|---|---|
| Pressure atm (kPa) | 2.00 | 2.25 | 2.50 | 2.75 | 3.00 | 3.50 | 4.00 |
| 3.0 (304) | 1.86 | 2.06 | 2.28 | 2.53 | 2.76 | 3.19 | 3.66 |
| 4.0 (405) | 1.93 | 2.14 | 2.37 | 2.61 | 2.85 | 3.30 | 3.80 |
| 5.0 (507) | 1.99 | 2.20 | 2.44 | 2.68 | 2.93 | 3.39 | 3.88 |
| 6.0 (608) | 2.03* | 2.26* | 2.50* | 2.75* | 3.00* | 3.46* | 3.96* |
| 7.0 (709) | 2.07 | 2.31 | 2.55 | 2.81 | 3.06 | 3.52 | 4.04 |
| 8.0 (811) | 2.10 | 2.34 | 2.59 | 2.85 | 3.11 | 3.57 | 4.09 |
| 9.0 (912) | 2.13 | 2.38 | 2.62 | 2.88 | 3.15 | 3.61 | 4.14 |
| 10.0 (1013) | 2.15 | 2.40 | 2.65 | 2.91 | 3.18 | 3.64 | 4.18 |
| 11.0 (1115) | 2.18 | 2.42 | 2.67 | 2.94 | 3.21 | 3.68 | 4.22 |
| 12.0 (1216) | 2.19 | 2.44 | 2.69 | 2.96 | 3.23 | 3.72** | 4.25** |
| 13.0 (1317) | 2.21 | 2.46 | 2.72 | 2.99 | 3.26 | ||
| 14.0 (1419) | 2.23** | 2.48** | 2.74** | 3.02** | 3.28** | ||
* Nominal Pressure
** Rated Burst Pressure. Do Not Exceed.
Modern PCI
The most complete Modern PCI portfolio in the industry
Ordering information
| Balloon Diameter (mm) | Balloon Length (mm) | |||
|---|---|---|---|---|
| E (mm) | 12 | 15 | 20 | 30 |
| 2.00 | H7493960812200 | H7493960815200 | H7493960820200 | H7493960830200 |
| 2.25 | H7493960812220 | H7493960815220 | H7493960820220 | H7493960830220 |
| 2.50 | H7493960812250 | H7493960815250 | H7493960820250 | H7493960830250 |
| 2.75 | H7493960812270 | H7493960815270 | H7493960820270 | H7493960830270 |
| 3.00 | H7493960812300 | H7493960815300 | H7493960820300 | H7493960830300 |
| 3.50 | H7493960812350 | H7493960815350 | H7493960820350 | H7493960830350 |
| 4.00 | H7493960812400 | H7493960815400 | H7493960820400 | H7493960830400 |
Modern PCI
The most complete Modern PCI portfolio in the industry
Education for AGENT DCB
Description: Learn from top operators about the use of the AGENT Drug-Coated Balloon (DCB) in Modern PCI. This video series, with cardiology experts, will take a closer look at clinical data and discuss optimizing treatment for patients with DCB technology.
Description: Gain clarity and confidence in imaging while exploring lessons from industry leaders, interactive learning exercises, and real-life case studies.
Online medical training and education courses
The EDUCARE online platform makes healthcare education and training more relevant, more comprehensive, more personal, and more accessible. Register to access a library of procedural videos, case studies, training resources, and events.
Transitional Pass-Through Payment
Effective January 1, 2025, the U.S. Centers for Medicare & Medicaid Services (CMS) has established a Transitional Pass-Through (TPT) payment category for coronary drug-coated balloons (DCBs).
TPT payments provide additional reimbursement under the Hospital Outpatient Prospective Payment System (OPPS) for new devices that are considered to be a substantial clinical improvement over existing technology. The intent of TPT payment is to facilitate Medicare beneficiary access to the advantages of innovative devices by allowing for adequate payment.17
To receive the TPT payment, hospitals must report C9610 on outpatient claims for cases using AGENT DCB along with the code for the associated procedure.18 Medicare will provide additional payment when C9610 is reported with the following CPT®/HCPCS procedure codes.
Please review the reimbursement resources below for additional information regarding coronary DCB coding and reimbursement.
For questions regarding AGENT Drug-Coated Balloon reimbursement, please contact the Boston Scientific Reimbursement Support Line.
Email: IC.Reimbursement@bsci.com
Outpatient
Quick reference guide discussing HCPCS C-Code reporting in the outpatient hospital setting.
Inpatient
Guide reviewing key information regarding accurately reporting heart failure diagnosis codes, why detailed reporting is important, and impacts to procedure payment.
Quick reference guide highlighting current inpatient coding, MS-DRG assignments, and national average payment rates.
Form to help with submitting hospital service reimbursement claims for AGENT DCB procedures.
Guide listing inpatient ICD-10-PCS coding scenarios for inpatient PCI procedures using AGENT DCB.
Physician (coming soon)
Additional resources for all sites of service
Quick reference guide discussing the ICD-10-CM diagnosis code reporting for in-stent restenosis (ISR).
These resources above are meant to be used by practicing physicians and allied healthcare professionals. These guides are not intended for patients or consumers.
Health economic and reimbursement information provided by Boston Scientific Corporation is gathered from third-party sources and is subject to change without notice as a result of complex and frequently changing laws, regulations, rules and policies. This information is presented for illustrative purposes only and does not constitute reimbursement or legal advice.
Resources
1. Stolker JM, Cohen DJ, Kennedy KF, Pencina MJ, Lindsey JB, Mauri L, Cutlip DE, Kleiman NS. Evaluation of Drug-Eluting Stents and Ischemic Events (EVENT) Investigators. Repeat revascularization after contemporary percutaneous coronary intervention: An evaluation of staged, target lesion, and other unplanned revascularization procedures during the first year
2. Moussa ID, Mohananey D, Saucedo J, et al. Trends and outcomes of restenosis after coronary stent implantation in the United States. J Am Coll Cardiol. 2020;76:1521–1531.
3. Kastrati A, Cassese S (2020). In-stent restenosis in the United States: Time to enrich its treatment armamentarium. In (Vol. 76, pp. 1532–1535): American College of Cardiology Foundation, Washington DC.
4. Tepe G, Brodmann M, Micari A, et al. 5-year outcomes of drug-coated balloons for peripheral artery in-stent restenosis, long lesions, and CTOs. JACC Cardiovasc Interv. 2023;16:1065–1078.
5. Kawamoto H, Ruparelia N, Latib A, et al. Drug-coated balloons versus second-generation drug-eluting stents for the management of recurrent multimetal-layered in-stent restenosis. JACC Cardiovasc Interv. 2015;8:1586–1594.
6. Yabushita H, Kawamoto H, Fujino Y, et al. Clinical outcomes of drug-eluting balloon for in-stent restenosis based on the number of metallic layers. Circ Cardiovasc Interv. 2018;11:e005935.
7. Market Data on file at BSC as of July 2023.
8. Nakamura M, Isawa T, Nakamura S, et al. Drug-coated balloon for the treatment of small vessel coronary artery disease – a randomized non-inferiority trial. Circ J. 2023;87:287–295.
9. Alfonso F, Coughlan JJ, Giacoppo D, Kastrati A, Byrne RA. Management of in-stent restenosis. EuroIntervention: Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2022;18:e103–e123.10. Market Data on file at BSC as of July 2023.
10. Surapaneni M, et al. International Scholarly Research Notices 2012.
11. Kim M, et al. International journal of nanomedicine (2011): 6:2997–3009. Enhanced bioavailability of sirolimus via preparation of solid dispersion nanoparticles using a supercritical antisolvent process.
12. Teichgräber, U, et al. Head-to-head comparison of sirolimus- versus paclitaxel-coated balloon angioplasty in the femoropopliteal artery: study protocol for the randomized controlled SIRONA trial. Trials 22, 665 (2021)
13. Tzafriri A, et al. Journal of Controlled Release. 2019; 310:94–102. Taking paclitaxel coated balloons to a higher level: Predicting coating dissolution kinetics, tissue retention and dosing dynamics
14. Granada J. What’s next in drug-eluting SFA technology? Endovascular Today. 2017;16:9.
15. Yeh RW, Bachinsky W, Stoler R, et al. Rationale and design of a randomized study comparing the AGENT drug-coated balloon to plain old balloon angioplasty in patients with in-stent restenosis. Am Heart J. 2021;241:101–107.
16. AGENT IDE Clinical Trial data presented at CRT 2024 by Dr. Robert Yeh.
17. Medicare Hospital Outpatient Prospective Payment System (OPPS) Final Rule; CMS-1809-FC; p. 507; This document is scheduled to be published in the Federal Register on 11/27/2024 and available online at https://federalregister.gov/d/2024-25521.
18. https://www.cms.gov/files/zip/january-2025-alpha-numeric-hcpcs-file.zip
Please review the AGENT Brief Summary for full instructions on use.
CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. The material not intended for use in France.
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