Cardioblate Gemini-s Surgical Ablation Device - Cardiac radio-frequency ablation system

Intended purpose

The device is intended to create transmural 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 Gemini-s surgical ablation device is a hand-held, single-use, bipolar, 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 to cool the tissue during RF energy delivery. The device is intended for intermittent operation.