Coronary microvascular dysfunction (CMD) remains a significant cause of angina in patients with no obstructive coronary artery disease (ANOCA), with limited therapeutic options. Building on prior evidence from the double-blind and sham-controlled COSIRA trial, which demonstrated the efficacy of the coronary sinus (CS) reducer in improving angina and quality of life in patients with refractory angina secondary to obstructive CAD, Tryon et al. explored its potential role in CMD.
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The CRL is related to observations of a third-party manufacturing facility as part of a standard prelicense inspection.
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