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In FDA-designed cohort study, mortality risk not related to paclitaxel-coated devices

In the SAFE-PAD cohort study of patients with peripheral artery disease designed in part by the FDA, there was no difference in mortality between those treated with paclitaxel-coated devices and those treated with uncoated devices.The results of SAFE-PAD, a retrospective cohort study designed after feedback from the FDA, were presented by Eric A. Secemsky, MD, MSc, RPVI, FACC, FSCAI, FSVM,

Boston Scientific Initiates First Coronary Drug-Coated Balloon Study in the U S

Boston Scientific Initiates First Coronary Drug-Coated Balloon Study in the U.S. AGENT IDE will evaluate the AGENT DCB as potential therapy for patients with in-stent restenosis, may offer alternative to repeated stenting or radiation therapy May 20, 2021   Boston Scientific Corporation announced it has initiated the AGENT IDE trial for the AGENT Drug-Coated Balloon (DCB), the first clinical trial in the U.S. to evaluate the safety and effectiveness of a DCB in patients with coronary in-stent restenosis (ISR). Coronary stenting, in which a stent is inserted into a coronary artery to restore blood flow to the heart, continues to show a substantial improvement in symptoms and quality of life for patients with coronary artery disease. However, in some patients, the stented section of the artery may become obstructed or narrowed by scar tissue, leading to a condition known as ISR. Approximately 10% of percutaneous coronary interventions (PCIs) address this issue and current treatme

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