New catheter approved to treat paroxysmal atrial fibrillation in Europe and the U.S.
- Sphere 360 catheter receives CE mark approval in Europe.
- First U.S. implant cases initiated for treating atrial fibrillation.
- Device aims to offer improved patient outcomes.
Medtronic has received CE mark approval in Europe for its Sphere 360 PFA catheter, designed for the treatment of paroxysmal atrial fibrillation. The catheter is aimed at improving patient outcomes by utilizing pulsed field ablation technology, which is intended to be more effective and safer for patients. With this approval, the Sphere 360 PFA catheter can now be used in clinical settings across Europe.
Additionally, Medtronic has initiated the first U.S. investigational device exemption (IDE) cases for the Sphere 360 catheter. These cases are part of a clinical study that will evaluate the device's performance and efficacy. Paroxysmal atrial fibrillation affects a significant number of patients, making this development critical for those who require effective treatment options.
The Sphere 360 PFA catheter aims to set a new standard in the treatment of atrial fibrillation by addressing the challenges associated with traditional ablation methods. As Medtronic continues to advance its cardiac solutions, ongoing studies will provide more insights into the catheter's long-term impact on patient health.
