Sunday, June 16

FDA OKs First Drug-Coated Balloon for In-Stent Restenosis

The United States Food and Drug Administration (FDA) has actually authorized Boston Scientific’s Agent Drug-Coated Balloon (DCB), the very first coronary DCB for the treatment of coronary in-stent restenosis in clients with coronary artery illness, the business has actually revealed in a press release.

In-stent restenosis comprises an approximated 10% of percutaneous coronary interventions in the United States.

The Agent DCB is a paclitaxel-coated balloon catheter that moves a restorative dosage of the antiproliferative drug to the vessel wall to assist avoid in-stent restenosis reoccurrence.

The FDA gave the Agent DCB development gadget classification in 2021. It authorized the gadget in part based upon arise from the AGENT IDE trial.

Carried out at 40 websites in the United States, the trial arbitrarily designated clients with coronary artery in-stent restenosis to the Agent DCB or to traditional balloon angioplasty.

In the prespecified interim analysis of the very first 480 clients registered, the research study fulfilled the main endpoint of target sore failure at 12 months, with the Agent DCB remarkable to uncoated balloon angioplasty (17.9% vs 28.7%; P =.006.

“This represented a 38% relative danger decrease along with a 10% outright danger decrease in the endpoint,” primary detective Robert Yeh, MD, of Beth Israel Deaconess Medical Center in Boston, reported at the Transcatheter Cardiovascular Therapeutics 2023 Congress.

Findings likewise consisted of no definite/probable cases of stent apoplexy (0.0% vs 3.9%; P =.001a 49% danger decrease in target-vessel associated myocardial infarction (6.4% vs 12.3%; P =.03and low negative occasion rates at 12 months, Boston Scientific kept in mind in the news release.

“The Agent IDE trial showed that the Agent DCB is an efficient and safe treatment alternative for coronary in-stent restenosis, even in a high-risk population, that included numerous people with multi-layer stents or diabetes,” Yeh included the release.

“Treating in-stent restenosis has actually been challenging in the U.S. with restricted treatments offered, and this brand-new innovation will assist doctors decrease the danger of restenosis without radiation or presenting extra metal layers, which do not offer an appropriate outcome for some clients,” Yeh stated.

Boston Scientific prepares to introduce the Agent DCB in the United States in the coming months. It’s currently readily available in Europe, parts of Asia Pacific, and Latin America.

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