St Jude Medical has received European CE mark for the Therapy Cool Flex Ablation Catheter at the 17th World Congress in Cardiac Electrophysiology and Cardiac Techniques (CardioStim).
Therapy Cool Flex Ablation Catheter is a cardiac ablation catheter which is used to treat cardiac arrhythmias. Catheters are thin flexible tubes that deliver radiofrequency (RF) energy to specific areas of cardiac tissue in order to create lesions, or tiny scars, that interrupt the abnormal electrical signals that contribute to irregular heart rhythms.
St Jude Medical said that the design of the Therapy Cool Flex Ablation Catheter features a flexible, laser-cut tip which can bend to conform to the cardiac anatomy. In addition, the laser cut design allows fluid to be infused around the entire catheter tip electrode. Together, the new features have been designed to allow for unmatched catheter tip cooling and increase the ability of the catheter to stay in contact with the endocardial surface.
The Therapy Cool Flex catheter tip has been designed for effective view of cardiac tissue anatomy using various angles of approach. The coil spring-loaded flexible tip can conform to the contours of the tissue up to 20 degrees when in contact with the endocardial surface. The Therapy Cool Flex is not currently available in the US.
The laser-cut tip electrode of the Therapy Cool Flex catheter was designed to provide optimal irrigation flow over the entire tip electrode for improved cooling compared to conventional irrigated catheter designs.
The catheter electrode features irrigation slits arranged in a zig-zag pattern and four ports at the distal end of the tip to allow irrigation to flow around the entire surface area of the tip. Additionally, the effect of the catheter tip bending and conforming to the tissue opens the irrigation slits on the side of the catheter tip facing the tissue, directing saline flow to the area where it is most needed the interface where the catheter tip meets the tissue.
The company said that the improved cooling capabilities may help to reduce some of the risk factors associated with the delivery of the RF energy, such as blood coagulation, charring and steam popping.
Jane Song, president of the atrial fibrillation division at St Jude Medical, said: “St Jude Medical has developed a very special and unique treatment solution for physicians with the Therapy Cool Flex Ablation Catheter. We believe that our flexible tip has a strong potential to replace a rigid tip as the new industry standard for irrigated catheter ablation. It is one of several potentially game-changing products that we look forward to bringing to market soon.”