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For patients with coronary artery disease (CAD) who have had stents placed, but whose blood vessels have closed again—i.e., restenosis—there is an emerging treatment option. Positioned as an alternative to a drug-eluting stent (DES), coronary drug-coated balloons (DCBs) represent a tremendous development in interventional cardiology. DCBs, first introduced internationally around 2000, have long been the standard of care for coronary in-stent restenosis (ISR) outside of the U.S. Now, twenty-four years later, the U.S. is beginning to catch up.
The Current Landscape
Boston Scientific’s AGENT™ DCB
In February 2024, Boston Scientific’s AGENT™ Paclitaxel-Coated Balloon became the first FDA-approved DCB in the U.S. for treating in-stent restenosis (ISR)—the blockage or narrowing of a stented vessel by plaque or scar tissue—in patients with CAD. AGENT™ is designed to help prevent ISR recurrence in adults undergoing percutaneous coronary intervention (PCI) in coronary arteries measuring 2.0 mm to 4.0 mm in diameter and with lesions up to 26 mm in length, without requiring additional stent placement.
After lesion preparation is completed—typically guided by angiography and intravascular imaging—the AGENT™ DCB is advanced to the target lesion. The balloon is inflated to deliver paclitaxel into the arterial wall. Once drug transfer is achieved, the balloon is deflated and removed, leaving no permanent implant behind. The drug remains active in the tissue for 60 to 90 days to help prevent restenosis.
Thus far, the clinical data published in March 2024 did indeed show that AGENT™ is superior to an uncoated balloon. Boston Scientific’s moves in this arena correspond to the field’s “leave nothing behind” trend. The price tag for that “nothing” is $6,175 per unit.
Medtronic’s Prevail™ DCB
In 2021, following the issuance of a CE mark, Medtronic launched the Prevail™ DCB Catheter in Europe; it is currently available in more than 80 countries. The device, meant for the treatment of de novo lesions, small vessel disease, and ISR, uses the PowerTrac™ technology and a hydrophilic coating to enhance the deliverability and “pushability” of the device.
Medtronic received FDA approval for an investigational device exemption in October 2024 to begin the pivotal Prevail global study looking at safety and effectiveness in patients with ISR and de novo small vessel disease; the first U.S. patient was enrolled in February 2025. In March 2025, the company announced two-year data from a retrospective, observational analysis using data from the Swedish coronary angiography and angioplasty registry, finding that the Prevail™ DCB had comparable outcomes to other DCBs used in the study.
Market Matters:
Driven by the anticipated rise in coronary artery disease, the drug-coated balloon market is projected to grow to $2.22 billion in 2029 at a compound annual growth rate of 15.6%. In the event that Medtronic’s Prevail receives FDA clearance—and if their outcomes outperform those of Boston Scientific’s AGENT™—there could be a substantial battle for market territory.
Reimbursement
While we know the cost of AGENT™ ($6,175 per unit), the cost of the Medtronic Prevail DCB is not publicly available at this time.
On January 1, 2025, CMS established two Category III CPT codes as well as a Transitional Pass-Through (TPT) payment category for coronary DCBs. This provides additional reimbursement under the Hospital Outpatient Prospective Payment System for new devices considered to be a substantial clinical improvement over existing technology. Currently, AGENT™ is the only FDA-approved coronary DCB eligible for these new codes and TPT payments.
Meant to facilitate temporary reimbursement while a permanent code is established, the TPT payments allowed by CMS provide reimbursement for new devices (outside of bundled rates) for up to three years.
After three years, DCB costs will be rolled into the existing Ambulatory Payment Classification (APC) rates. Although what that means for reimbursement remains unclear, we might glean wisdom from the 2018 CMS decision to not create a separate reimbursement code for peripheral DCBs. The decision rattled stakeholders, who pointed to evidence from three randomized controlled trials showing clearly that the use of drug-coated balloons compared to angioplasty alone is superior. Hospitals were left holding the bag, as it were, being forced to cover the cost of the DCBs.
Fast forward to 2022, when a study found a statistically significant drop in DCB use after TPT was suspended. The authors cited ethical issues, echoing others who expressed concerns that elderly and disadvantaged patients who rely on Medicare and Medicaid will be assigned to suboptimal treatment with plain angioplasty.
Effects on Hospitals and Supply Chains
The use of coronary DCBs requires coordinated efforts across clinical, operational, and financial teams. While AGENT™ is currently approved only for ISR, expanded use may be on the horizon pending future FDA approvals. Given the higher acquisition cost compared to standard balloons or drug-eluting stents, accurate charge capture and cost tracking are essential. As non-routine inventory, DCBs should be managed with clear clinical justification and appropriate procedural use. Planning for the eventual expiration of TPT reimbursement will be critical, particularly as hospitals prepare for bundled payment transitions and shifting APC structures. Cross-functional collaboration among physicians, supply chain leaders, and finance teams will be key to ensuring clinical decisions, economic stewardship, and reimbursement readiness are aligned as the market for coronary DCBs continues to evolve.
Going Forward
Coronary DCBs have demonstrated clear clinical value in the treatment of in-stent restenosis, which affects approximately 10–20% of patients with coronary stents. Sustained adoption, however, will rely on strong cross-functional coordination. Only through close collaboration between physicians, supply chain teams, and finance leaders can hospitals ensure that clinical decision-making, cost management, and reimbursement planning are aligned. This level of alignment will be essential to maintaining patient access to DCBs as their use expands and as reimbursement structures evolve beyond the transitional support currently in place.
