ElectroWire Medical Secures FDA 510(k) Clearance for LightningWire Transseptal System
Shots:
- The US FDA has granted 510(k) clearance to the LightningWire Transseptal Puncture System, indicated to create an atrial septal defect to enable the introduction of cardiovascular catheters
- LightningWire combines an electrosurgical guidewire & activation cable for transseptal access, working with preferred introducers & existing electrosurgical generators. Its insulation enables low-power puncture, while the 0.032-inch wire provides broad device compatibility and added stiffness
- The system is designed for procedures incl. atrial fibrillation ablation, left atrial appendage occlusion, & transcatheter mitral valve repair or replacement, with ElectroWire planning an immediate limited market release
Ref: PRnewswire | Image: ElectroWire Medical | Press Release
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