ElectroWire earns FDA clearance for heart device

A new medical device company in the Midlands has received FDA clearance commercialize a product designed for heart procedures.

ElectroWire Medical has received U.S. Food and Drug Administration clearance for its LightningWire Transseptal Puncture System, marking a milestone for the Lexington County-based medical device company bringing its first product to market.

The company opened its Lexington County manufacturing facility last year now plans its first in-human procedures to take place in August, according to a news release.

The FDA clearance allows ElectroWire to begin commercializing the LightningWire system, which is designed to improve transseptal access during minimally invasive heart procedures, according to the release. 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,” company founder Dr. Robert Leonardi said in the release. “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 in-human procedures in August, followed by a limited market release in South Carolina and neighboring states later this year, the release stated. 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,” Leonardi said in the release. “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.”