A clean lab in Burnaby, B.C., where Kardium makes a medical device that treats atrial fibrillation. Kardium's product has generated better clinical results than its rivals.

One of Canada’s most promising life-sciences companies, Kardium Inc., has received regulatory approval to take its medical device to market in the United States.

Kardium, developer of a device to treat a common heart problem called atrial fibrillation (AF), said Wednesday the U.S. Food and Drug Administration had given premarket approval for its technology as a Class 3 medical device. That stringent designation means it could be used within weeks in U.S. heart procedures, chief executive officer Kevin Chaplin said in an interview.

“This is the biggest milestone in the company’s 18-year history,” he said. “It’s been a

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