A US clinical study is just getting under way that, if successful, could lead to a cure for the most common type of cardiac arrhythmia. The study is evaluating a new type of cryogenic catheter co-developed by the National Institute of Standards and Technology (NIST).
The catheter system, which is being commercialised by CryoCor of San Diego, CA., is designed to selectively freeze cardiac tissue in order to block the abnormal electrical signals that cause arrhythmia, thereby returning the heart to its normal rhythm.
The system consists of a catheter about 3mm in diameter, a sheath for introducing the catheter into pulmonary veins, and a console for controlling the temperature of refrigerant inside the catheter and thus the size of the tissue area to be frozen. Inside the heart, the catheter can achieve temperatures below – 80 degrees Celsius (-112 degrees Fahrenheit).
On June 29th, the company announced that it had received Food and Drug Administration (FDA) approval for clinical trials to evaluate the system’s safety and efficacy in treating atrial fibrillation, an irregular heart rhythm that increases the risk of stroke and death. Clinical trials are already under way to treat atrial flutter, or rapid heart rate.
International clinical trials had a 98% overall treatment success rate, and the company has approval to sell the system in Europe.
The technology offers a potential cure for arrhythmia, whereas current treatments, including drug therapy and implantable devices such as pacemakers, simply manage the condition.