Medtronic Announces First Procedures in Pivotal Trial to Evaluate Novel Ablation Technology in Treating Atrial Fibrillation
Study Will Determine the Safety and Effectiveness of Pulsed Electrical Fields to Interrupt Irregular Heart Rhythms Medtronic plc the global leader in medical technology, today announced the first procedures in the investigational device exemption pivotal trial to evaluate the PulseSelect ™ Pulsed Field Ablation System, a novel, breakthrough technology that uses pulsed electric fields to treat atrial fibrillation . … Study Will Determine the Safety and Effectiveness of Pulsed Electrical Fields to Interrupt Irregular Heart Rhythms
Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced the first procedures in the investigational device exemption (IDE) pivotal trial to evaluate the PulseSelect ™ Pulsed Field Ablation (PFA) System, a novel, breakthrough technology that uses pulsed electric fields to treat atrial fibrillation (A
Medtronic Recalls Unused Valiant Navion Thoracic Stent Grafts
Physicians directed to immediately cease use of the Medtronic Valiant Navion thoracic stent graft system
February 23, 2021 Medtronic has voluntarily issued a global recall of unused Medtronic Valiant Navion thoracic stent graft system and informed physicians to immediately cease use of the device until further notice.
Medtronic initiated this action in response to information recently obtained from the Valiant Evo Global Clinical Trial indicating that three patients in the Valiant Evo Global Clinical Trial were observed to have stent fractures. Two of these stent fractures resulted in confirmed type IIIb endoleaks. One patient death was reported, the company said.
FDA Clears Medtronic DiamondTemp Ablation System to Treat Atrial Fibrillation
Clinical trial demonstrates procedural efficiencies, safety and effectiveness of DiamondTemp System
Medtronic s DiamondTemp Ablation (DTA) system is FDA cleared to treat patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) and who have been unresponsive to drug therapy. The DiamondTemp system is the first FDA-approved, temperature-controlled, irrigated radiofrequency (RF) ablation system with diamonds currently available to deliver ablations.
January 29, 2021 The U.S. Food and Drug Administration (FDA) has cleared Medtronic s DiamondTemp Ablation (DTA) system to treat patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) and who have been unresponsive to drug therapy. The DiamondTemp system is the first FDA-approved, temperature-controlled, irrigated radiofrequency (RF) ablation system with diamonds currently available to deliver ablations.
Medtronic Receives FDA Approval of DiamondTemp Ablation System for the Treatment of Patients with Atrial Fibrillation
Clinical Trial Demonstrates Procedural Efficiencies, Safety, Effectiveness and Non-Inferiority of DiamondTemp System
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DUBLIN, Jan. 29, 2021 /PRNewswire/ Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) approval of the DiamondTemp™ Ablation (DTA) system which treats patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) and who have been unresponsive to drug therapy. The DiamondTemp system is the first FDA-approved, temperature-controlled, irrigated radiofrequency (RF) ablation system with diamonds currently available to deliver ablations.