Kardium, a Canadian medical device company focused on the treatment of atrial fibrillation, has completed the first-in-human study of its next-generation Globe Pulsed Field (PF) system.
The Globe PF system works by delivering pulsed field ablation (PFA) therapy to treat patients with atrial fibrillation (AF).
Kardium said that its team has treated 38 patients using the Globe Pulsed Field System, and successfully isolated the pulmonary veins in all the patients.
The team worked together with Dr Vivek Reddy from Mount Sinai Hospital in New York, US, and Professor Petr Neužil and Dr Jan Petrů from Na Homolce Hospital in Prague, Czech Republic.
Dr Reddy said: “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.
“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 also create a mitral isthmus line.”
The Globe PF system features an advanced Globe Catheter that is equipped with 122 electrodes, each of which allows for high-definition mapping and delivering PFA.
The catheter leverages contact sensing technology to determine which electrodes are in contact with cardiac tissue to ensure effective delivery of the therapy to the heart.
Its patented design allows for rapid, single-shot pulmonary vein isolation (PVI), high-definition mapping, and atrial ablation, said the company.
In the clinical study, patients with paroxysmal AF received PVI treatment in under 16 minutes, and those with persistent AF received PVI treatment.
The Globe PF System was used to create a high-definition map of the entire atrium using real-time 3-D mapping capabilities, said the company.
Kardium CEO Kevin Chaplin said: “The Globe PF System is designed to be a safe, effective, and rapid treatment for AF. We are extremely 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 PVI three months after the procedure.”
Furthermore, Kardium intends to conduct a global clinical study of the Globe PF System in the US, Canada, Germany, and the Czech Republic, to obtain regulatory approval.
