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.”
Kevin Chaplin, 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 like strokes and heart failure. The condition can potentially lead to shorter life expectancy unless it is effectively treated.
Kardium has been developing tech to treat AF since it was founded in 2007, The recent regulatory decision helps Kardium bring the device to market in the US.
“The FDA approval of the Globe System represents the most significant milestone in the life of Kardium,” CEO Kevin Chaplin said in a statement. “We are extremely proud of the achievements of the team to deliver on our mission of developing the best treatment for AF.”
Chaplin told The Globe and Mail that the FDA has approved its tech as a Class 3 medical device. This is astringent designation that means it could be used in heart procedures within weeks.
Kardium’s Globe System uses a method called pulsed field ablation (PFA). It consists of a “sophisticated catheter” with 122 electrodes that works in tandem with software to permit rapid pulmonary vein isolation, or the practice of delivering an electric pulse to target problematic cells. It also provides high-definition mapping and precision targeting the atria.
Other companies developing tech to treat AF with PFA include Boston Scientific, Johnson & Johnson, and Medtronic.
News of the FDA approval comes shortly after Kardium closed $340 million CAD in funding earlier this summer to secure regulatory approval and expand manufacturing for its Globe System.
According to The Globe and Mail, Kardium intends to submit to regulators in Canada and Europe next, where it hopes to gain approval to sell its device in 2026.
Feature image courtesy Nappy via Unsplash.