-

Kardium Receives CE Mark for Globe® Mapping and Ablation System

Announces launch of commercial sales in Europe

VANCOUVER, British Columbia--(BUSINESS WIRE)--Kardium Inc. has received CE mark approval for its Globe Mapping and Ablation System – the most complete solution for the treatment of atrial fibrillation (AF). AF is the world’s most common heart rhythm disorder, affecting more than 37 million people. This approval allows Kardium to begin commercial sales of the Globe System in Europe.

“This is an important milestone both for Kardium and the global AF community,” said Kevin Chaplin, CEO of Kardium. “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.”

The spherical Globe catheter has 122 electrodes and, when combined with the Globe System’s sophisticated software, is the only device that provides the EP with single-shot pulmonary vein isolation, high-definition mapping, and atrial ablation, giving the most complete solution for treating AF.

“The Globe Mapping and Ablation System has the potential to completely revolutionize the way we treat atrial fibrillation,” said Prof. Hans Kottkamp, Head of Electrophysiology, Sana Hospitals, Düsseldorf. “By combining single-shot ablation with high-resolution mapping and the ability to ablate anywhere in the left atrium, the Globe System gives us a comprehensive solution to treat both paroxysmal and persistent AF.”

The CE mark approval was based on the positive results from the GLOBAL-AF study, a multi-centre study that demonstrated the safety and effectiveness of the Globe Mapping and Ablation System.

Kardium GmbH has been formed in Dortmund, Germany to handle commercial sales of the Globe System in Europe.

ABOUT KARDIUM

Kardium Inc. (kardium.com) is a rapidly growing medical solutions company that has developed an advanced system for the treatment of atrial fibrillation: the Globe Mapping and Ablation System. Kardium has built an outstanding team of engineers, medical researchers, compliance and production staff who have worked with top medical advisors to develop the Globe System. Founded in 2007 and headquartered in Vancouver, Canada, Kardium has consistently ranked as one of the top companies to work for in British Columbia.

Contacts

Kevin Chaplin, CEO, Kardium Inc.
+1-604-248-8891 x 277 | kevin.chaplin@kardium.com

Kardium Inc.


Release Versions

Contacts

Kevin Chaplin, CEO, Kardium Inc.
+1-604-248-8891 x 277 | kevin.chaplin@kardium.com

More News From Kardium Inc.

Kardium Announces First Patient Enrollment in the Globe Registry, Expanding Real-World Evidence for the Globe® Pulsed Field System Following Strong Early Commercial Experience

VANCOUVER, British Columbia--(BUSINESS WIRE)--Kardium today announced the first site activation and first patient enrollment in the Globe Registry: Globe® Pulsed Field System Registry for Treating Patients with Symptomatic Atrial Fibrillation. The registry marks an important milestone in the continued commercial adoption of the Globe System following positive physician experience, strong procedural outcomes, and a growing body of evidence supporting the system's unique integrated mapping and ab...

Kardium Launches the “Globe Durability Guarantee”™ – Highlighting the Outstanding Durability of the Globe® System

VANCOUVER, British Columbia--(BUSINESS WIRE)--Kardium Inc., a medical device solutions company behind the Globe® System, announced the launch of the “Globe Durability Guarantee”™, which is designed to provide patients and physicians with additional confidence in the Globe System’s ability to deliver durable treatment with only one procedure. The Globe Durability Guarantee promises that if a patient treated with the Globe System returns for a redo ablation and pulmonary vein reconnection is obse...

Kardium Receives Funding From the Government of Canada to Expand Manufacturing of the Globe® Pulsed Field System in British Columbia

VANCOUVER, British Columbia--(BUSINESS WIRE)--The Government of Canada today announced funding of up to $31.25 million through the Strategic Response Fund (SRF) toward Kardium’s investment in a $125 million project to expand its manufacturing capabilities in Vancouver, British Columbia. The announcement was made by the Honourable Mélanie Joly, Minister of Industry and Minister responsible for Canada Economic Development for Quebec Regions. The investment will support a major expansion of Kardiu...
Back to Newsroom