ElectroWire’s LightningWire Transseptal Puncture System Used in First Clinical Cases

September 16, 2026—ElectroWire Medical announced the successful completion of its first clinical cases performed with the LightningWire transseptal puncture system.

In July 2026, the company announced that the FDA granted 510(k) clearance for the LightningWire system, which is indicated to create an atrial septal defect in the heart, whereby various cardiovascular catheters are introduced. The company began commercialization of the device with a limited market release.

The LightningWire technology is intended to address procedures including catheter ablation of atrial fibrillation, left atrial appendage occlusion, and transcatheter mitral valve repair and replacement, noted ElectroWire.

The first procedures were performed by structural interventional cardiologist Nalin Srivastava, MD, and cardiac electrophysiologist David Rodak, MD, at Spartanburg Medical Center in Spartanburg, South Carolina.

According to the company, the procedures included one mitral valve repair, one left atrial appendage occlusion, and four pulsed field ablations. The cases were performed using four different transseptal introducers and two different electrosurgical generators, demonstrating the LightningWire system’s compatibility across a range of operator-preferred and already-available equipment. All procedures were completed successfully with no complications, noted ElectroWire.

Dr. Srivastava performed the first-in-human use of the LightningWire system, delivering a 24-F steerable guide catheter into the left atrium for mitral valve repair.

“I think you’re onto something here,” commented Dr. Srivastava in the press release. “The mechanical and electrosurgical performance of the LightningWire, combined with ease of use with the operator having control of the radiofrequency on the table, makes this a very attractive option to streamline every transseptal procedure.”