St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced Japanese Ministry of Health, Labour and Welfare (MHLW) approval and reimbursement approval of its Therapy™ Cool Path™ Ablation Catheter. This marks the company's first entry into the irrigated catheter ablation market in Japan.
“The Therapy Cool Path ablation catheter is the first of many product and technology launches that will put more control in the hands of physicians.”
Cardiac ablation catheters are used to help treat cardiac arrhythmias, which are irregular heartbeats that impair the heart's ability to effectively pump blood to the body. The Therapy Cool Path Ablation Catheter is a thin, flexible tube that delivers 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.
Irrigated catheters, such as the Therapy Cool Path, are designed to cool the ablation electrode with the intent of reducing some of the risk factors associated with the heat of the RF energy, such as blood coagulation and charring as the amount of energy required to create an effective cardiac lesion must be carefully balanced against tissue temperature. Additionally, irrigation is designed to allow for the creation of larger and deeper lesions, because the saline fluid from the catheter helps to cool the catheter tip and tissue. The larger and deeper legions help to stop the arrhythmia at its source, which can be deep within the heart muscle by treating the area causing the abnormal heart rhythm.
"I believe that catheter ablation is an essential therapy to treat any cardiac arrhythmia. In my experience, the Cool Path ablation system has a unique irrigation function that helps control the temperature, which remarkably improves the effectiveness and safety of ablation and I believe will expand the application of ablation therapy," said Yoshito Iesaka, MD, Deputy Director, Tsuchiura Kyodo General Hospital.
"With research continuing to demonstrate that ablation is safe and effective therapy for the treatment of cardiac arrhythmias, we are pleased to offer advanced ablation technology to the Japanese market," said Jane J. Song, president of the St. Jude Medical Atrial Fibrillation Division. "The Therapy Cool Path ablation catheter is the first of many product and technology launches that will put more control in the hands of physicians."