Kardium treats first patient in pulsed-field ablation study

The Globe PF pulsed-field ablation catheter. [Image from Kardium]Kardium announced today that it successfully treated the first patients in the PULSAR clinical study for its Globe PF pulsed-field ablation (PFA) system.

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 …

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Kardium lands CE Mark for mapping and ablation device

Kardium announced that it received CE Mark approval in Europe for its Globe mapping and ablation system for treating atrial fibrillation (AF).

Vancouver, B.C.-based Kardium’s spherical Globe catheter is comprised of 122 electrodes to provide electrophysiologists with single-shot pulmonary vein isolation, high-definition mapping and atrial ablation, according to a news release.

Approval in Europe came off the back of positive results from the company’s Global-AF multi-center study that demonstrated the safety and effectiveness of the Globe system.

“This is an important milestone both for Kardium and the global AF community,” Kardium CEO Kevin Chaplin said in the release. “The Globe system can now be used by electrophysiologists (EPs) across Europe to safely and effectively treat patients with AF. We have a sales and support team in place and are now launching the Globe system for clinical use in Europe.”

Commercial sales and support for…

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