multipolar circular mapping catheter (balloon cryoablation for pulmonary vein isolation)

Product Name:
Country: United Kingdom (UK)

National Institute for Health and Care Excellence

Outcome Measure

a. Efficacy: Specialist Advisers key efficacy outcomes: Electrical isolation of 'all pulmonary veins' or 'all 4 pulmonary veins', procedure duration, freedom from atrial fibrillation, avoidance of repeat procedures and reduced use of anti -arrhythmic drugs<br>b. Safety: Specialist Advisers theoretical adverse events include death, atrio-oesophageal fistula permanent phrenic nerve palsy, damage to structures anatomically close to pulmonary veins, deep vein thrombosis (p. 3ff)

Body Classification

Blood, Heart and Circulation

Device Type

Therapeutic device

Device Category

Treatment of disease

Risk Classification

III

Indication

atrial fibrillation

ICD-10

I48

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