Articles from Kardium Inc.

Kardium Inc., a private medical device company that’s advancing the way the world treats atrial fibrillation (AF), announced late-breaking, one-year clinical trial results for its innovative pulsed field ablation (PFA) device—the Globe PF System. These pivotal findings from the PULSAR IDE study were announced at the Heart Rhythm Society (HRS) meeting in San Diego1, highlighting the safety and efficacy data of the Globe PF System, which is currently under PMA review with the US FDA.

Kardium Inc., developer of the Globe® Mapping and Ablation System for the treatment of atrial fibrillation, has raised US $104 million in a new financing round. The round is led by existing investor Fidelity Management & Research Company, together with follow-on participation by funds and accounts advised by T. Rowe Price Associates, Inc. and T. Rowe Price Investment Management, Inc. as well as new investor Durable Capital Partners LP.

Kardium Inc., a private medical device company that has developed the Globe® System for the treatment of atrial fibrillation (AF), announced positive results of the 1-year outcomes of the First-in-Human PULSE-EU Trial. These findings were presented as late-breaking clinical data at the Heart Rhythm Society (HRS) 2024 Annual Meeting and simultaneously published in the Heart Rhythm Journal.

Kardium Inc., a private medical device company that has developed the Globe® System for the treatment of atrial fibrillation (AF), announced today that it had successfully treated a series of patients delivering therapy in both the left and right atria. After successfully completing pulmonary vein isolation (PVI) and posterior wall ablation in the left atrium, the Globe Catheter was subsequently re-deployed in the right atrium, and successful therapy was delivered for right atrial cavotricuspid isthmus (CTI) dependent atrial flutter (AFL). The ablation procedures were also completed utilizing pulsed field (PF) energy, radiofrequency (RF) energy, or a hybrid combination of both, all using sedation without the need for general anesthesia.

Kardium Inc., a private medical device company that has developed the Globe® System for the treatment of atrial fibrillation (AF) using pulsed field ablation (PFA), announced today the successful completion of enrollment in the paroxysmal cohort of the pivotal PULSAR IDE (Investigational Device Exemption) study. This achievement marks a significant milestone in the journey to bring this groundbreaking technology to patients in the United States, with data from the study to be submitted to the Food and Drug Administration (FDA) for Pre-Market Approval (PMA).

Kardium Inc., a private medical device company that has developed the Globe System for the treatment of atrial fibrillation (AF) using pulsed field ablation (PFA), announced today that the first US patients have been successfully treated in the PULSAR clinical study.

Kardium Inc., a private medical device company that has developed the Globe® PF System for the treatment of atrial fibrillation (AF) using pulsed field ablation (PFA), announced today that the first patients have been successfully treated in its PULSAR clinical study. The international, multicenter study recently received U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval in the United States, Health Canada approval in Canada, and SUKL approval in the Czech Republic, to validate the safety and effectiveness of the Globe System.

Kardium Inc. announces the successful first-in-human study of its next generation Globe® Pulsed Field System to treat atrial fibrillation (AF) using pulsed field ablation (PFA) therapy. Working with Dr. Vivek Reddy1 from Mount Sinai Hospital (New York, USA), and Prof. Petr Neužil and Dr. Jan Petrů from Na Homolce Hospital (Prague, Czech Republic), the Kardium® team successfully treated 38 patients, isolating 100% of the patients’ pulmonary veins using the Globe Pulsed Field System.

Kardium Inc. announces a successful first-in-BC investigational* clinical procedure using the Globe® Mapping and Ablation System. Dr. Marc Deyell of St. Paul's Hospital leads the study using the Globe System to navigate inside the heart and diagnose where the rhythm disturbances occur. Once identified, the same device can then deliver immediate treatment to restore the normal heart rhythm and confirm successful treatment.

Kardium Inc. announces the completion of successful first-in-human (FIH) procedures with the Globe Pulsed Field System.