Medtronic Expands CE Mark Indication For Affera System For Ventricular Arrhythmias Treatment

Medtronic said its Sphere-9 catheter with Affera mapping and ablation system received a CE mark in Europe for ventricular arrhythmia treatment. The system previously had CE for atrial arrhythmias (initially March 2023) and FDA clearance for the same (October 2024). Medtronic is also running a US trial and seeking FDA clearance.

Medtronic (NYSE: MDT) said it expanded the CE Mark indication for its Affera Mapping and Ablation System with the Sphere-9 catheter to treat ventricular arrhythmias, including ventricular tachycardia and PVCs. Medtronic also reported FDA Breakthrough Device Designation for Sphere-9 and that the U.S. Sphere VT pivotal trial is enrolling patients.

A federal jury in Massachusetts awarded Alabama couple Larry and Tammy Patterson $88 million in a hernia mesh case against Covidien, a Medtronic subsidiary. The jury found Covidien failed to adequately warn about risks of its Symbotex mesh. Larry received $77 million and Tammy $11 million. The verdict was the first federal bellwether in a multidistrict litigation with over 2,500 pending suits.

A federal jury ordered Medtronic to pay $88 million to an Alabama man and his wife in the first hernia mesh test trial. The case alleged Medtronic’s Covidien division failed to warn about risks of its Symbotex implanted mesh used in 2017. Medtronic said it will seek post-trial relief and appeal, while about 10,350 plaintiffs remain in similar litigation.

A federal jury ordered Medtronic (NYSE:MDT) to pay $88 million to an Alabama couple in the first hernia mesh trial tied to implants made by its Covidien unit. The jury found Covidien failed to adequately warn of risks, and no punitive damages or fraud were awarded. Medtronic said it will seek post-trial motions and appeal.

Reuters reports Medtronic was ordered to pay $88 million in a bellwether hernia mesh lawsuit. The plaintiff alleged bowel adhesions after use of Covidien Symbotex mesh and required revision surgery. Reuters says this was the first trial among thousands, with about 2,500 similar Covidien hernia mesh cases pending in federal MDL.