Cardioblate XL Pen - Cardiac radio-frequency ablation system

Intended purpose

The device is intended to create spot or linear lesions in atrial cardiac tissue using irrigated radiofrequency energy under direct or endoscopic visualization in surgical procedures, including minimally invasive surgical procedures.

Functional description

The Cardioblate XL surgical ablation pen is a hand-held, single-use, monopolar, radiofrequency (RF) ablation device for use in cardiac surgery. It has a saline irrigation system to deliver fluid at the contact point between the tissue and electrode tip to cool the tissue during RF energy delivery. The device is intended for intermittent operation.