Recently CardioFocus Inc., the makers of the HeartLight Endoscopic Ablation System (EAS), launched its pivotal trial in the U.S. and has already enrolled their first patient participant. The trial is supposed to monitor the efficacy and safety of the device, which the company hopes will be used to treat AF.
The first patient is a 48-year-old who sufferers from paroxysmal AF. The patient has had the condition for three years and has already undergone a successful pulmonary vein (PV) isolation at Mount Sinai School of Medicine in New York. For the procedure, all four PVs had been isolated on the very first try, and the doctors used visual guidance to help them work their way around. The procedure took two hours.
This new HeartLight EAS is to be the very first catheter ablation system that will incorporate an endoscope to help provide a better visual of the heart when it’s beating. This will be done in real time and without the use of radiation. The HeartLight EAS includes a dynamically adjustable balloon catheter that will be used to help make the contact better with the opening no matter what the patient’s individual anatomy is. This new technology is going to use laser energy as a means of providing more efficient, precise and durable ablation. The FDA decided to approve the HeartLight EAS in December so that this trial could be performed.
“The visually-guided HeartLight EAS is unique in cardiac catheter ablation and offers a promising new treatment option for drug-refractory atrial fibrillation. For the first time, physicians can see within a beating heart to more precisely deliver ablation energy and confirm contiguous lesion placement, which we believe may lead to improved patient outcomes,” said Vivek Y. Reddy, MD, of Mount Sinai School of Medicine, and Principal Investigator of the trial. “The system has been used with great clinical success in Europe, with recent published data supporting the high rate of both acute and durable PV isolation enabled by the device. We are optimistic that we will be able to achieve similar results in this trial.”
Catheter ablations have become a safer means of treating patients with AF since the medications used to treat AF are known to cause serious side effects and even death. One of those medications is Multaq. Some of the side effects linked to Multaq use include liver failure and a worsening of the heart condition. Some patients taking Multaq even die. Because of the dangers linked to Multaq, most doctors won’t prescribe the drug unless other drugs aren’t working.
If you or a loved one has developed liver failure or a worsening of your heart condition after taking Multaq, contact the attorneys at Greg Jones today for a free consultation. We are experienced at fighting Multaq lawsuits and may be able to help you recover money for your injuries.