Biotronik Pamira ICD leads with active fixation - HSA Registration DE0510059
Access comprehensive regulatory information for Biotronik Pamira ICD leads with active fixation in the Singapore medical device market through Pure Global AI's free database. This CLASS COM medical device is registered under HSA registration number DE0510059 and owned by BIOTRONIK SE & Co. KG. The device was registered on November 20, 2024.
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The leads transmit electrical signals to & from the heart muscle & are implanted in the right ventricle of the heart via a transvenous approach. The implantation of leads is intended to enable a compatible ICD device to: • sense electrical activity of the heart to monitor • pace the right ventricle, including antitachycardia pacing (ATP) • deliver therapeutic shocks. To avoid increasing pacing thresholds, a steroid eluting collar is located at the lead tip, reducing myocardial inflammation after implantation & subsequent fibrosis. In combination with a compatible ICD, these leads are indicated for patients with risk of sudden cardiac death caused by ventricular arrhythmia -ventricular tachycardia/ventricular fibrillation. Secondary prevention cases include survivors of sudden cardiac arrest and patients with history of symptomatic sustained VT/VF. Primary prevention cases include patients with heart failure with severe left ventricular dysfunction despite optimal medical therapy