A B.C. medtech firm has received the green light to enter the U.S. with its heart rhythm treatment system.
Burnaby-based Kardium Inc. announced Wednesday that it has received pre-market approval from the U.S. Food and Drug Administration (FDA) for the Globe Pulsed Field System, which helps treat atrial fibrillation (AF)—an irregular heartbeat—more effectively.
“The FDA approval of the Globe System represents the most significant milestone in the life of Kardium,” said Kevin Chaplin, CEO of Kardium, in a Wednesday statement.
“We are extremely proud of the achievements of the team in delivering on our mission of developing the best treatment for AF. The Globe System supports a personalized, efficient and effective AF treatment.”
The Globe System is a cardiac mapping and ablation platform that enables single-shot pulmonary vein isolation (PVI) and targeted, customizable ablation using a single catheter.
The system is designed to improve outcomes, streamline workflows, and expand treatment options for patients with atrial fibrillation, according to Kardium.
“I am excited to have the Globe System available in the U.S.,” said Vivek Reddy, director of cardiac arrhythmia services at the Mount Sinai Fuster Heart Hospital in New York.
“The Globe System’s ability to achieve highly durable lesions with an excellent safety profile, together with integrated high-density mapping and true single-shot PVI, offers a distinctive and comprehensive approach to treating atrial fibrillation.”
Kardium has raised several rounds of investment in recent years. In July, the firm secured US$250 million to support the commercial launch of the Globe Pulsed Field System, following a US$104-million round last year and US$115 million in 2021.
Its flagship product received approval from European regulators in 2020, and North American clinical trials began in 2022 at St. Paul’s Hospital in Vancouver.
