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Results from the FlexPulse IDE study showed that Abbott’s TactiFlex Duo catheter, which combines pulsed-field ablation and radiofrequency ablation, achieved efficacy and safety after one year of treating patients with paroxysmal atrial fibrillation. The company plans to use the data as the basis for submitting an application to the FDA to market the catheter in the United States.
Medtronic generated $9.8 billion in revenue in the first fiscal quarter of FY27, up 13.7% year over year, driven particularly by its cardiac business and cardiac ablation solutions. The company raised its annual organic revenue growth outlook and also provided updates on the adoption of the Hugo surgical robot.
Boston Scientific halted the distribution and use of Imager II Angiographic Catheters after discovering that they were manufactured with low levels of tip bonding materials, which could lead to tip deterioration or detachment inside a blood vessel. The company reported two serious injuries linked to the issue as of July 16, while the FDA issued an early alert about it.
Abbott has received the European CE mark for the Amulet 360, an upgraded version of its device for closing the left atrial appendage in certain patients with atrial fibrillation in order to reduce the risk of stroke. The company is preparing to expand the device’s use in European countries in the coming weeks, amid direct competition with Boston Scientific’s Watchman device.
Boston Scientific disclosed a cyberattack that caused a network outage and disrupted business systems and technologies supporting the processing and shipment of customer orders worldwide. The company is still investigating the incident and has not yet determined its full scope or financial impact.