Dive Brief:
- Medtronic said Wednesday it has received clearances for cardiac mapping and ablation software in the U.S. and Europe.
- Authorities in both regions cleared Medtronic’s Affera Prism-2 Mapping Software, which creates three-dimensional maps of the heart’s electrical activity during cardiac ablation procedures.
- Medtronic also received a CE mark for the PulseSelect ProxBox Adapter with Proximity Indicator software, a product that adds real-time feedback to one of its pulsed field ablation systems.
Dive Insight:
“Software excellence” is a priority for Medtronic’s electrophysiology unit and is “central to the integrated experience physicians expect,” Rebecca Seidel, president of electrophysiology therapies at the company, said in a statement. The latest regulatory milestones further Medtronic’s efforts to use software to gain an edge in a fast-growing PFA market targeted by Abbott, Boston Scientific and Johnson & Johnson.
Medtronic’s Affera Prism-2 software now has Food and Drug Administration clearance and a CE mark supporting use in Europe. Using magnetic and impedance-based tracking, the software shows the location of diagnostic catheters on a three-dimensional map. The software supports procedures that use little or no fluoroscopy, an X-ray technique for imaging the inside of the body in real time.
The Prism-2 software “unlocks meaningful benefits, including improved navigation using hybrid impedance and magnetic mapping to better visualize non-sensor-based catheters,” Medtronic CEO Geoff Martha said on an earnings call in June. At that time, Medtronic was rolling out Prism-2 globally following a quarter in which the U.S. Affera installed base grew 40% sequentially, Martha said.
Medtronic received 510(k) clearance for updated Affera mapping software in August. The filing covered new features disclosed in Wednesday’s statement that help physicians identify heartbeats with abnormal signals and mark when pacing is performed during a procedure.
Physicians use Affera mapping software with Medtronic’s Sphere-9 catheter.
Medtronic disclosed the Prism-2 clearances alongside a CE mark for new PulseSelect capabilities. The updated system provides real-time, impedance-based feedback to help physicians check that the catheter is near the targeted heart tissue before delivering energy.
