MetaMedical™ Solutions Inc

FDA approves Boston Scientific’s drug-coated balloon

The US Food and Drug Administration (FDA) has approved Boston Scientific’s Agent drug-coated balloon for the treatment of coronary in-stent restenosis (ISR), obstruction or narrowing of a stented vessel.

The Agent balloon works by inflating to reopen the stent and diffuses paclitaxel – a chemotherapy drug that maintains the patency of the lumen of the blood vessel. The device received the breakthrough device designation by the FDA in 2021.

The medtech giant plans to launch the Agent drug-coated balloon in the US in the coming months. The technology is already available in Europe and parts of Asia Pacific and Latin America.

Coronary stenting is a standard procedure for treating patients with coronary artery disease, but the stented section of the artery can become occluded due to plaque or scar tissue – resulting in coronary in-stent restenosis. A review study found that around 10% of percutaneous coronary interventions are for coronary in-stent restenosis treatment.

The cardiovascular device market is expected to grow from being worth approximately $59.9bn in 2023 to more than $86.6bn in 2030, as per GlobalData market analysis. The interventional cardiology sector is expected to be worth $12.5bn in 2030.

The FDA approval of the Agent drug-coated balloon was based on the data from the AGENT IDE clinical trial (NCT04647253). The trial met its primary endpoint of target lesion failure – a composite of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target lesion revascularisation. At 12 months, the device had target lesion failure rates of 17.9%, compared to 28.7% in the control group.

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By GlobalData

Compared to the uncoated balloon, Agent DCB had a risk reduction of 49% and 51% in myocardial infarction related to the target vessel and target lesion revascularisation, respectively. The drug-coated balloon group reported low adverse event rates and did not have any cases of stent clotting.

Boston Scientific has received FDA clearance for multiple devices in the last year. In September 2023, the agency cleared Boston Scientific’s Watchman FLX pro left atrial appendage closure (LAAC) device. The device acts similar to a ‘plug’ to stop the blood from entering the appendage and by doing so stops blood clot formation, reducing the risk of stroke.

Boston Scientific also acquired Relievant Medsystems in November 2023. The company’s FDA-cleared Intracept Intraosseous Nerve Ablation System that treats chronic low back pain, known as vertebrogenic pain, was at the centre of the acquisition.

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