Medtronic said it has received Europe’s CE mark for its Affera system that integrates pulsed field ablation with radiofrequency to treat abnormally fast heart rhythms, and provides real-time feedback to the physician through mapping and navigation software.
The system generates anatomical maps that allow physicians to choose between PFA and RF to deliver the ablation lesions, depending on the patient and procedure needs.
The European approval for Affera follows the company’s announcement in December that it completed enrollment in a U.S. Investigational Device Exemption pivotal trial to evaluate the safety and effectiveness of the system for persistent atrial fibrillation. That study is now in its 12-month follow-up phase, Medtronic said Wednesday in a press release.
The Affera mapping and ablation system will be commercially available beginning in the first half of 2023 in Europe and is still investigational in the United States. Medtronic acquired Affera in August 2022.
Medtronic also is developing the PulseSelect pulsed field ablation system, which currently is investigational and not approved for sale or distribution. The company earlier this month presented results from a single-arm study showing the device exceeded safety and efficacy goals.
Pulsed field ablation is a newer procedure using electrical pulses to scar heart tissue in the treatment of atrial fibrillation, the most common heart arrhythmia. Johnson & Johnson and Boston Scientific are developing competing devices.
In a separate announcement Wednesday, Medtronic was named among the investors in a $25 million financing round for FIRE1, the Dublin-based developer of a remote monitoring system for heart failure patients.
