ElectroWire Medical Announces Successful First Clinical Cases with LightningWire Transseptal Puncture System

Six Cases Across Mitral, LAA, and PFA Workflows Completed with Zero Complications

LEXINGTON, S.C., Sept. 9, 2026 /PRNewswire/ -- ElectroWire Medical, developer of the FDA-cleared LightningWire™ Transseptal Puncture System, today announced the successful completion of its first clinical cases, performed at Spartanburg Medical Center in Spartanburg, South Carolina.

The procedures were performed by Dr. Nalin Srivastava, a structural interventional cardiologist, and Dr. David Rodak, a cardiac electrophysiologist, and 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.

Dr. Srivastava performed first-in-human use of the LightningWire system, successfully delivering a 24-French steerable guide catheter into the left atrium for mitral valve repair. "I think you're onto something here," he said. "The mechanical and electrosurgical performance of the LightningWire, combined with ease of use with the operator having control of the RF on the table, makes this a very attractive option to streamline every transseptal procedure."

"Before clinical use, it's difficult to know if you've made something that will work well in the real world, and that people will actually want," said Dr. Robert Leonardi, Founder of ElectroWire Medical.  "We're thrilled to see the LightningWire system work beautifully in a variety of transseptal procedures in the real world, and for physicians and laboratory staff to provide positive feedback."  The LightningWire technology is positioned to bring value to all procedures in the rapidly growing transseptal access systems market, including catheter ablation of atrial fibrillation, left atrial appendage occlusion, and transcatheter mitral valve repair and replacement.

About LightningWire™

The LightningWire system combines a novel electrosurgical guidewire and activation cable to simplify transseptal puncture and delivery of cardiovascular devices. The LightningWire's proprietary insulation design optimizes mechanical properties and electrosurgical performance along the length of the wire. Despite its 0.032-inch labeled diameter, which facilitates broad compatibility with various transseptal devices, the LightningWire is stiffer than the market-leading 0.035-inch guidewire¹ to support efficient transseptal delivery of therapy devices. Robust insulation allows transseptal puncture at low power settings. Further improving compatibility, the LightningWire's activation cable connects to separately cleared, pre-existing electrosurgical generators and puts control of radiofrequency energy in the operator's hands on the sterile field.

About ElectroWire Medical

ElectroWire Medical is a Lexington, South Carolina-based medical device technology startup focused on setting new standards for transseptal access and device delivery.  Its flagship product, the LightningWire Transseptal Puncture System, is FDA-cleared and in limited market release.  For more information, visit https://electrowiremedical.com/.  For updates, follow ElectroWire Medical on LinkedIn and X.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.  For indications and important safety information, visit https://www.electrowiremedical.com/isi.

¹ Data on File at ElectroWire Medical

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SOURCE ElectroWire Medical