Burnaby, BC-based medical technology company Kardium has received pre-market approval from the United States (US) Food and Drug Administration (FDA) for its innovative heart device: the Globe Pulsed Field System ( Globe System ).

The company has also been given 510(k) clearance for both the Globe Introducer sheath and Globe mapping software.

“The FDA approval of the Globe System represents the most significant milestone in the life of Kardium.”

The Globe System is designed to treat a common heart problem called atrial fibrillation (AF), AF is an irregular heartbeat disorder that affects more than 59 million people globally. It causes rapid, chaotic beating of upper heart chambers (atria), which can induce dizziness, fainting, fatigue, shortness of breath, and more serious complications

See Full Page