Cardioblate BP2 System - Cardiac radio-frequency ablation system

Intended purpose

The devices are intended to create transmural and 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 BP2 surgical ablation device is a hand-held, single-use, bipolar, and the Cardioblate surgical ablation pen is a hand-held, single-use, monopolar, radiofrequency (RF) ablation device, for use in cardiac surgery. They both have 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.