Advancing Cardiac Care: FDA Approves Revolutionary Drug-Coated Balloon for Coronary In-Stent Restenosis

In a groundbreaking development of cardiac care, the U.S.¬†Food and Drug Administration (FDA)¬†has approved a novel therapeutic approach to managing Coronary In-Stent Restenosis (ISR). Renowned Pharmaceutical’s AGENT, the first¬†Drug-Coated Balloon (DCB)¬†designed specifically for coronary treatment, has received the FDA’s nod, ushering in a new era in the battle against ISR. This approval comes after promising results from the AGENT IDE trial, offering hope for physicians seeking effective alternatives in the challenging landscape of cardiovascular interventions.

Advancing Cardiac Care: Understanding Coronary In-Stent Restenosis

Advancing Cardiac Care

Coronary In-Stent Restenosis poses a significant challenge in interventional cardiology. It occurs when the vessel previously treated with stenting becomes narrowed or obstructed due to plaque or scar tissue formation. Despite the substantial improvements brought about by coronary stenting in the quality of life for patients with coronary artery disease (CAD), ISR continues to account for 10% of percutaneous coronary interventions in the United States.

The Role of AGENT Drug-Coated Balloon

Advancing Cardiac Care:

AGENT, the paclitaxel-coated drug-coated balloon, has emerged as a beacon of innovation in addressing the critical unmet needs of ISR. The FDA’s approval underscores its significance as the first-of-its-kind coronary DCB in the United States. AGENT’s therapeutic potential lies in its ability to provide a dedicated treatment option for ISR without resorting to additional layers of radiation, stenting, or conventional balloon angioplasty.

Key Findings from the AGENT IDE Trial

The pivotal AGENT IDE trial secured FDA approval for AGENT DCB. In this prospective, multicenter, randomized controlled study involving 600 patients across 40 U.S. sites, the interim analysis of the first 480 patients revealed compelling results. AGENT DCB demonstrated statistical superiority over uncoated balloon angioplasty, showcasing a significant reduction in target lesion failure (TLF) at 12 months (17.9% vs. 28.7%). Noteworthy outcomes also included:

  1. Zero Cases of Clotting within the Stent: The AGENT DCB group reported no definite/probable cases of clotting within the stent, highlighting its safety profile compared to conventional interventions (0.0% vs. 3.9%).
  2. Risk Reduction in Heart Attack at Target Vessel: A remarkable 49% reduction in the risk of heart attack at the target vessel was observed using AGENT DCB (6.4% vs. 12.3%).
  3. Low Adverse Event Rates at 12 Months: The study reported low adverse event rates, further supporting the safety and efficacy of AGENT DCB at the 12-month mark.

Clinical Significance and Impact on Patient Care

For physicians navigating the complexities of ISR treatment, AGENT DCB offers a transformative solution. With over 100,000 patients treated globally in clinical and commercial settings, this proven therapy brings a new dimension to the therapeutic armamentarium. The drug-coated balloon transfers a therapeutic dose of paclitaxel to the vessel wall, addressing the root cause of ISR and aiming to prevent its recurrence.

The Approval Process and Breakthrough Device Designation

Advancing Cardiac Care:

The journey to FDA approval for AGENT DCB began with the grant of Breakthrough Device Designation in 2021. This designation facilitated an expedited regulatory pathway, recognizing the technology’s potential to address a critical unmet need in cardiovascular care. Positive results from the AGENT IDE trial provided robust clinical evidence, culminating in the recent approval that positions AGENT as a pioneering solution for ISR.

Future Implications and Global Availability

AGENT DCB has already made strides in international markets. It is available in Europe, Asia Pacific, and Latin America for treating ISR and previously untreated small vessel coronary disease. The mother pharmaceutics plans to launch this innovative technology in the United States in the coming months, marking a significant advancement in the options available to physicians and their patients.


The FDA approval of AGENT DCB represents a landmark moment in cardiovascular medicine, offering a paradigm shift in the management of Coronary In-Stent Restenosis. With its proven efficacy, safety profile, and global success, AGENT DCB has the potential to reshape the landscape of coronary interventions. As physicians, embracing this groundbreaking technology can open new avenues in providing optimal care for patients grappling with the challenges of ISR, ultimately contributing to improved outcomes and enhanced quality of life.


  1. FDA Approves First Drug-Coated Balloon to Treat Coronary In-Stent Restenosis [Internet]. Medscape Medical News (Accessed on March 06, 2024). Available from:

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