Medtronic Inc. announced Monday that the U.S. Food and Drug Administration has approved the Achieve Mapping Catheter, an intra-cardiac electrophysiology diagnostic catheter that can be used to assess pulmonary vein isolation when treating paroxysmal atrial fibrillation (PAF).
PAF is an irregular heartbeat that affects people only intermittently and generally stops in less than seven days.
The Fridley, Minnesota-based company’s new catheter technology can only be used with its Arctic Front Cardiac CryoAblation Catheter System. In discussing the company’s fiscal third-quarter earnings on Feb. 22, Medtronic CEO Bill Hawkins noted that the company had received FDA approval for that system, the only cryoballoon ablation treatment that is approved in the U.S. for paroxysmal AF. Now with the approval of the catheter, pulmonary vein diagnostic and ablation capabilities are combined in a single system. Last week, the first patient procedure in the United States using the new catheter was performed by Dr. Robert Kowal, an electrophysiologist at the Baylor Heart & Vascular Hospital in Dallas.
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Roughly 15,000 Arctic Front procedures have been performed worldwide, including 1,000 procedures with the Achieve Mapping Catheter in Europe, according to Medtronic, which makes new innovative medical devices.
“The Achieve Mapping Catheter, which enables physicians to engage in real-time evaluation of pulmonary vein isolation during the Arctic Front procedure, underscores Medtronic’s commitment to providing physicians with a comprehensive medical solution for treating atrial fibrillation and improving patient quality of life,” said Reggie Groves, vice president and general manager of Medtronic’s AF Solutions division, in a statement.
