Vancouver, British Columbia-based Kardium recently received FDA investigational device exemption (IDE) to conduct the study. The international, multicenter PULSAR study evaluates the safety and effectiveness of Globe PF for the treatment of AFib using PFA.
The study also received Health Canada approval and SUKL approval in the Czech Republic, according to a news release.
Kardium said it expects the PULSAR study to enroll more than 400 patients across up to 35 sites. These sites range between the U.S., Canada and Europe. Dr. Vivek Reddy (Mt. Sinai Hospital, New York) and Dr. Atul Verma (McGill University Health Centre, Montreal) are principal investigators. Dr. Reddy, Prof. Petr Neužil and Dr. Jan Petru treated the first patients this week at …