ElectroWire Medical has announced the completion of the first clinical cases with its US Food and Drug Administration (FDA)-cleared LightningWire transseptal puncture system at Spartanburg Medical Center in Spartanburg, USA.
The procedures were performed by Nalin Srivastava, a structural interventional cardiologist, and 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, the company said in a press release, also reporting that the procedures were completed successfully with no complications.
Srivastava performed first-in-human use of the LightningWire system, successfully delivering a 24Fr steerable guide catheter into the left atrium for mitral valve repair.
“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,” he said.
“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 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.”
