A drug-coated balloon made by Boston Scientific reduced the risk of heart attack in patients with complications from stents, researchers reported on Wednesday.
Boston Scientific hopes to use this data to win approval from the Food and Drug Administration. The company has not yet published its full slate of data in a journal. Outside experts told STAT they needed more data before assessing the device’s full potential.
The treatment is meant for patients whose arteries have shrunk even after receiving a stent to open up the clogged vessel. Stent placement sometimes causes scar tissue to build up and prevent blood flow. Cardiologists can use drug-eluting stents to prevent scar formation, but the condition still occurs in around 10% of patients who have those stents implanted. Out of all minimally invasive procedures performed to open up clogged arteries, 10% address the disorder, called in-stent restenosis. ISR can cause chest pain and increase risk of heart attack.
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