ElectroWire Medical’s Novel LightningWire System Earns FDA 510(k) Clearance

ElectroWire Medical has received 510(k) clearance from the US Food and Drug Administration for its LightningWire Transseptal Puncture System, a device designed to create an atrial septal opening to support the introduction of cardiovascular catheters.
The system combines an electrosurgical guidewire with a dedicated activation cable and is designed to work with commonly used transseptal introducers and separately cleared electrosurgical generators.

Its insulation design is intended to support electrosurgical performance while maintaining mechanical properties along the guidewire.

The LightningWire has a labelled diameter of 0.032 inches and is designed for compatibility with a range of transseptal devices. Its construction also provides additional stiffness to support the delivery of therapeutic devices following transseptal access. 

The activation cable allows clinicians to control radiofrequency energy from the sterile field during the procedure.

The system is intended for use across several cardiovascular procedures requiring transseptal access, including catheter ablation for atrial fibrillation, left atrial appendage occlusion, and transcatheter mitral valve repair and replacement.

The company plans to begin a limited commercial release of the LightningWire system. 

The clearance marks a regulatory milestone for the South Carolina-based medical device company as it seeks to expand access to its transseptal technology.