Kardium CEO Kevin Chaplin holds a Globe Pulsed Field System medical deviceJimmy Jeong/The Globe and Mail
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 long journey for us and to have all our work and efforts validated is extremely exciting.”
The company will submit next to regulators in Canada and Europe and hopes to get approval to sell in those markets in 2026.
Kardium raises $340-million as B.C. heart device maker prepares for FDA approval, market entry
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.Jimmy Jeong/The Globe and Mail
AF is an irregular heartbeat disorder that affects more than 59 million people worldwide and can lead to complications such as stroke and heart failure.
Kardium, which has raised more than US$550-million from investors – including US$250-million earlier this summer, is one of several players bringing devices to market that treat AF with a method called pulsed field ablation (PFA). Its financial backers include sovereign wealth fund Qatar Investment Authority, Fidelity Management & Research Co., T. Rowe Price Associates, Inc. and several venture-capital firms.
Boston Scientific BSX-N generated US$1-billion in sales from its PFA device in 2024 after winning FDA approval that year. Medtronic plc MDT-N, an American-Irish company, expects similar sales for its PFA product.
Kardium has generated better clinical results than both rivals. In April, it published results from a study of 183 patients showing 77.8 per cent were free of AF 12 months after being treated with its technology, with no device-related “primary safety events.”
Competing developers reported between 0.7 per cent and 2.2 per cent adverse safety events, while their treatments kept 66.7 per cent to 73.3 per cent of patients AF-free for a year.
Kardium’s technology combines several existing approaches that treat different aspects of AF into a single device designed to save time and improve results.
The key is a three-centimetre-diameter disco-ball-like globe with 122 golden, individually controlled electrodes. The sphere is flattened, encased in a sheath, inserted in a patient’s femoral vein and threaded into the heart’s left atrium. It is then expanded to sphere form and maps the inside of the heart to pinpoint where erratic electrical signals originate before destroying the problem cells.
The device was originally designed to burn the cells using radio frequencies. But in 2021, Kardium shifted to the emerging PFA approach, whereby its device sends rapid, high voltage pulses to rupture targeted cells, restoring the heart’s normal rhythms without damaging adjacent cells like the older approach.
Pitching in: Improving treatment for abnormal heart rhythm
Kardium CEO Kevin Chaplin holds a Globe Pulsed Field System device.Jimmy Jeong/The Globe and Mail
Mr. Chaplin said Kardium has the capacity to make up to 50,000 devices annually – which are used once and sell for US$10,000 to US$12,000 – at its existing facilities in the Vancouver area. “We’ll be building several thousands of these devices and have tens of millions of dollars in revenue” within the next 18 months, he said.
He added Kardium expects to decide by the end of the year on where to expand its manufacturing. Mr. Chaplin said the company is talking with the B.C. and federal governments about support to locate some of that additional manufacturing in Canada, but it is also eyeing a “lower-cost manufacturing jurisdiction. The size of this market is so huge we need to build as much manufacturing capacity as we can.”
The 500-person company also plans to go public in one to two years, once it has at least 12 months of revenue and commercialization efforts behind it.
The company based in Burnaby, B.C., was co-founded in 2007 by Daniel Gelbart and Amos Michelson – the former chief technology officer and chief executive officer, respectively, of local printing-technology maker Creo Inc., which sold to Eastman Kodak in 2005 for US$980-million. The other co-founders were Dr. Sam Lichtenstein, head of the University of British Columbia’s cardiac surgery division, and original Kardium chief executive officer Doug Goertzen, now president and chief operating officer.