The 9 Fr. catheter is designed for use under real-time magnetic resonance imaging (MRI) guidance for the treatment of heart conditions.
The device allows electrophysiologists to visualize cardiac soft tissue with precision and clarity while using what looks, feels, and functions like a traditional ablation catheter, according to Imricor’s website.
It is the company’s first device to receive FDA clearance.
“This is obviously a tremendous milestone for the Imricor team, and I want to acknowledge the outstanding work of the entire team in reaching this achievement,” chair and CEO Steve Wedan said in a news release. “Most of us have worked at companies that have existing medical devices on the U.S. market, and getting a new device on the market is always a big deal. But getting a company’s first device on the U.S. market is an extraordinarily big deal.”
The device was used in the first ischemic ventricular tachycardia ablation ever performed under real-time MRI guidance in an iCMR lab by an Amsterdam University Medical Centre team in the Netherlands in November last year.
“With MRI-guided treatment of heart conditions, we are working towards fewer procedures per patient, hospital admissions, and less medication,” said Dr. Marco Götte, a member of the Amsterdam UMC operating team, on Imricor’s website. “Perhaps MRI-guided treatment of heart disease will become the norm and replace X-ray-driven treatments.”
