Lexington, S.C. – September 13, 2026 -- ElectroWire Medical's FDA-cleared LightningWire Transseptal Puncture System has completed its first six clinical cases at Spartanburg Medical Center in Spartanburg, South Carolina, with zero complications reported.
Six procedures spanned mitral repair, LAA occlusion and pulsed field ablation
The case mix included one mitral valve repair, one left atrial appendage occlusion, and four pulsed field ablations, performed by structural interventional cardiologist Dr. Nalin Srivastava and cardiac electrophysiologist Dr. David Rodak. The team used four different transseptal introducers and two different electrosurgical generators during the cases, testing the device's compatibility with equipment already in operator inventories.
First-in-human use delivered a 24-French guide catheter for mitral repair
Dr. Srivastava performed the first-in-human use of the LightningWire system, successfully delivering a 24-French steerable guide catheter into the left atrium for a mitral valve repair procedure. He said the device's mechanical and electrosurgical performance, combined with operator control of RF energy on the table, makes it an attractive option to streamline transseptal procedures.
Device carries a 0.032-inch profile but outperforms 0.035-inch guidewires on stiffness
Despite its 0.032-inch labeled diameter, the LightningWire is stiffer than the market-leading 0.035-inch guidewire, according to company data on file, supporting delivery of therapy devices across transseptal access. Its insulation design allows puncture at low power settings, and the activation cable connects to separately cleared, pre-existing electrosurgical generators rather than requiring proprietary hardware.
ElectroWire targets the expanding transseptal access systems market
Robert Leonardi, Founder of ElectroWire Medical, said the company had been uncertain how the device would perform in real-world use before these cases. The LightningWire is now in limited market release, with the company positioning the technology for use across atrial fibrillation ablation, left atrial appendage occlusion, and transcatheter mitral valve repair and replacement procedures.