Abbott PFA system gains FDA approval
Abbott has received U.S. Food and Drug Administration (FDA) approval for its Volt Pulsed Field Ablation (PFA) System to treat patients with atrial fibrillation (AFib). The company expects commercial cases to begin in the United States in the near future.
The Volt PFA System, which already gained CE mark approval in March, was designed with the a significant amount of physician feedback. It works with Abbott’s EnSite X EP heart mapping technology, which the company has said improves accuracy and limits the number of catheter exchanges during treatment. Abbott also noted that patients treated with Volt can be placed under conscious sedation instead of general anesthesia.
Another feature of this technology that stands out is the balloon-in-basket design of its catheter. This is intended to provide clinicians with increased flexibility as they target the patient’s tissues.
“AFib is a progressive condition where timely intervention is critical to disease management and, ultimately, the patient's quality of life,” DJ Lakkireddy, MD, executive medical director of the Kansas City Heart Rhythm Institute and an early user of the Volt system, said in a statement. “When I perform a cardiac ablation, I look for a tool with an excellent patient safety profile that can simplify the treatment of AFib. Volt is a promising option for patients. Its real-time contact visualization and unique balloon-in-basket design provide superior tissue contact and focused energy delivery, while addressing some of the limitations of the early generation PFA systems.”
“We heard the physician feedback that patients need an alternative to general anesthesia during a PFA ablation procedure that doesn't sacrifice strong outcomes,” added Christopher Piorkowski, MD, chief medical officer of Abbott's electrophysiology business. “The Volt PFA System is an option for patients who prefer conscious sedation, which can also lead to faster recovery times and shorter procedures for the millions of Americans who suffer from an abnormal heart rhythm.”
PFA building more and more momentum
PFA uses high-voltage electrical pulses to treat paroxysmal and persistent AFib, as opposed to the heat and cold used by radiofrequency ablation and cryoablation, respectively. It is one of the most in-demand technologies in all of electrophysiology.
PFA has gained so much momentum that the Heart Rhythm Society just announced a new registry for collecting and storing real-time data on PFA patients. To minimize the burden of data entry, the registry will use advanced artificial intelligence algorithms and direct electronic health record integration.
Other FDA-approved PFA systems include Medtronic’s PulseSelect and Affera systems, Boston Scientific’s Farapulse system and Johnson & Johnson MedTech’s Varipulse Platform.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.