Coronary SurgeryFDARegulatoryThursday, October 15, 2026
Early Alert: Transcatheter Mitral Valve Delivery System Issue from Edwards Lifesciences
1 min read·By E. Nolan Beckett, MD·Source: FDA MedWatch Safety Alerts
From The Cardiac Wire
The coronary story today is physiology, not grafts.
Continuous thermodilution in 51 patients with anomalous aortic origin of a coronary artery showed that the high-risk anatomic triad (intramural segment, acute take-off, slit-like ostium) produces measurably reduced hyperemic flow (179 vs 290 mL/min) and elevated microvascular resistance at rest and under stress.
Editor’s take pending for this article; this is the section commentary excerpt.
Source Abstract
Potential balloon burst during inflation can lead to embolism or the need for surgery.
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Full article at FDA MedWatch Safety Alerts
Open at FDA MedWatch Safety Alerts →The Cardiac Wire summarizes; we link out to primary sources for verification.
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Elsewhere in Today’s Issue
- Clinical Trials Update· Annals of Thoracic SurgeryTopical Vancomycin for Prevention of Grade 2 or Higher Sternal Wound Infection After Cardiac Surgery: A Randomized Controlled Trial
- Aortic Surgery· Frontiers in surgeryUnexplained intraoperative cardiac tamponade during thoracoscopic lobectomy: a case report.
- Valve Surgery· Clinical physiology and functional imagingThe durability of different anchoring points and anchoring types in the left ventricle in an ex vivo porcine model.