Milestone for Lexington County Company
Lexington, SC 07/17/2026 – ElectroWire Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its LightningWire™ Transseptal Puncture System, marking another milestone for the Lexington County-based medical device company as it prepares to bring its first product to market.
The clearance allows ElectroWire to begin commercializing the LightningWire™ system, which is designed to improve transseptal access during minimally invasive heart procedures. The technology is designed for compatibility with existing electrosurgical generators and a broad range of transseptal devices used in today's cardiac procedures. Since announcing plans to establish operations in Lexington County in December 2024, ElectroWire opened its manufacturing facility in August 2025, received FDA clearance for its first product and is now preparing for commercialization.
"ElectroWire was founded to set a new standard for transseptal access and device delivery," said Dr. Robert Leonardi, founder of ElectroWire Medical. "We think we've done that with our LightningWire™ technology, which we expect to benefit patients, their physicians and the hospitals and ambulatory surgery centers where transseptal procedures are performed."
ElectroWire plans to begin first-in-human procedures in August, followed by a limited market release in South Carolina and neighboring states later this year. A broader national rollout is anticipated in 2027 while the company continues generating clinical data to further demonstrate the technology's safety, efficacy and clinical utility.
"Receiving FDA clearance is an important step for ElectroWire and validates years of research, development and collaboration," said Dr. Leonardi. "We're excited to begin introducing LightningWire™ to physicians through a limited market release while continuing to generate clinical data that supports the technology and its potential to improve patient care."
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