Kardium’s Globe Pulsed Field System is Focus of First-in-Human Study

 Kardium Inc. is conducting the first-in-human study of its next-generation Globe Pulsed Field System, which uses pulsed field ablation (PFA) therapy to treat atrial fibrillation (AF).

Working with Dr. Vivek Reddy* from Mount Sinai Hospital (New York, N.Y.), and Prof. Petr Neužil and Dr. Jan Petrů from Na Homolce Hospital (Prague, Czech Republic), the Kardium team successfully treated 38 patients, isolating all patients’ pulmonary veins using the Globe Pulsed Field System. “PVI with the Globe PF System was very easy. I could quickly position the catheter in each pulmonary vein, ensure that the electrodes were in good contact, and then deliver pulsed field energy to isolate each vein safely and rapidly from one position,” Reddy said. “I also really liked the system’s flexibility in more complex cases. I could map the atrium and then deliver additional pulsed field lesions to isolate the posterior wall quickly and then create a mitral isthmus line.”
 
The Globe Pulsed Field (PF) System features the company’s Globe Catheter with 122 gold electrodes, each of which can map the patient’s cardiac anatomy and electrical activity and deliver PFA energy to the heart to treat afib. The Globe Catheter uses contact sensing to determine which electrodes are in contact with cardiac tissue to help ensure therapy is delivered effectively to the heart.

“The Globe PF System is designed to be a safe, effective and rapid treatment for AF,” Kardium CEO Kevin Chaplin said. “We are excited by these procedures, which demonstrate the flexibility and ease of use of the Globe PF System. Previous clinical cases with the Globe PF System have achieved 100% durable PV isolation three months after the procedure.
 
In this study, patients with paroxysmal AF received pulmonary vein isolation (PVI) treatment in as little as 16 minutes. Patients with persistent AF received PVI treatment, and then the Globe PF System was used to create a high-definition map of the entire atrium using real-time 3D mapping capabilities. Using these maps, all of the patients with persistent AF received additional ablation of the posterior wall and several patients also received a mitral isthmus line, all using the same Globe Catheter.
 
Kardium now plans to conduct a global pivotal clinical study of the Globe PF System in the United States, Canada, Germany, and the Czech Republic to obtain regulatory approval for commercial sales.
 
Kardium Inc. is a medical solutions company that has developed an advanced atrial fibrillation (AF) treatment system. The Globe Pulsed Field System is an all-in-one solution for treating atrial fibrillation, which affects more than 59 million people worldwide. 

* Dr. Reddy is a Kardium consultant.