Home Medizin FDA genehmigt ersten medikamentenbeschichteten Ballon für In-Stent-Restenose

FDA genehmigt ersten medikamentenbeschichteten Ballon für In-Stent-Restenose

von NFI Redaktion

The Food and Drug Administration (FDA) in the United States has approved Boston Scientific’s Drug-Coated Balloon (DCB), the first coronary DCB for the treatment of coronary in-stent restenosis in patients with coronary heart disease, the company announced in a press release.

In-stent restenosis accounts for approximately 10% of percutaneous coronary interventions in the United States.

The DCB agent is a balloon catheter coated with paclitaxel, which delivers a therapeutic dose of the antiproliferative drug to the vessel wall to prevent the recurrence of in-stent restenosis.

In 2021, the FDA granted breakthrough device designation to the DCB agent, partially based on the results of the AGENT IDE study.

The study, conducted at 40 sites in the United States, randomly assigned patients with coronary artery in-stent restenosis to receive the DCB agent or conventional balloon angioplasty.

In a pre-specified interim analysis of the first 480 enrolled patients, the study met the primary endpoint of target lesion failure at 12 months, with the DCB agent being superior to uncoated balloon angioplasty (17.9% vs. 28.7%; P = .006).

„This represented a 38% relative risk reduction and a 10% absolute risk reduction in the endpoint,“ reported lead investigator Robert Yeh, MD, from Beth Israel Deaconess Medical Center in Boston, at the 2023 Transcatheter Cardiocular Therapeutics Congress.

The results also included no definite/probable cases of stent thrombosis (0.0% vs. 3.9%; P = .001), a 49% risk reduction in target vessel-related myocardial infarctions (6.4% vs. 12.3%; P = .03), and low rates of adverse events at 12 months, as noted by Boston Scientific in the press release.

„The AGENT IDE study has shown that the Agent DCB is an effective and safe treatment option for coronary in-stent restenosis, even in a high-risk population including many individuals with multiple stents or diabetes,“ Yeh added in the press release.

Boston Scientific plans to launch the Agent DCB in the United States in the coming months. It is already available in Europe, parts of the Asia-Pacific region, and Latin America.

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