Shots:
- CoreMap received the US FDA’s IDE approval of CoreMap EP (Endocardial Electrophysiology) to extend the 3-phase INvENI clinical study into the US in pts with Atrial Fibrillation (AF) and long-standing persistent AF
- The P-I study assessed acute safety of CoreMap EP in 14 pts while P-II study showed acute safety & effectiveness in 15 pts. The P-III study will evaluate CoreMap-guided ablation + PVI vs SoC PVI and PWI in de novo persistent AF pts, who will be followed for 12mos. to assess freedom from AF, atrial tachycardia, & atrial flutter recurrence
- CoreMap EP Mapping system has already demonstrated safety and acute effectiveness in over 50 pts
Ref: Globenewswire| Image: Coremap| Press Release
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