A new type of defibrillator met safety, effectiveness goals in global clinical study

A new type of extravascular implantable cardioverter-defibrillator (ICD) using a lead (thin wire) placed behind the sternum met safety and effectiveness goals for participants in a premarket global clinical study. The device effectively terminated acute and chronic life-threatening ventricular arrhythmias. The findings were presented during a late-breaking session at the European Society of Cardiology Congress and were simultaneously published in The New England Journal of Medicine.

Thermedical Announces FDA Approval of Clinical Trial for SERF Ablation to Treat Patients with Ventricular Tachycardia, Leading Cause of Sudden Cardiac Death

WALTHAM, Mass., Aug. 23, 2022 – Thermedical®, a developer of thermal-ablation systems to treat ventricular arrhythmias, announced today that the U.S. Food & Drug Administration (FDA) has approved an open-label, single-arm interventional clinical trial to evaluate the safety and efficacy of the Thermedical® SERF Ablation System with the Durablate® Catheter in people with ventricular tachycardia (VT) resistant to conventional treatment.

20-year Mayo Clinic study suggests return to play is manageable for athletes with most genetic heart diseases

Receiving the diagnosis of a genetic heart disease such as long QT syndrome, which can cause sudden cardiac death, has long been a game-ender for young athletes. But a 20-year study at Mayo Clinic following such athletes who were allowed to return to play suggests that the risks can be managed through a shared decision-making process. The retrospective study findings will be presented at the annual meeting of the Heart Rhythm Society on Tuesday, July 27, and simultaneously published in the Journal of the American College of Cardiology.