ElectroWire Medical has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for its LightningWire transseptal puncture system, which is indicated to create an atrial septal defect in the heart via which various cardiovascular catheters can be introduced.
The LightningWire system combines a novel electrosurgical guidewire with a dedicated activation cable to simplify procedures using preferred transseptal introducers and existing electrosurgical generators, according to an ElectroWire press release. The device’s proprietary insulation design optimises electrosurgical performance and mechanical properties along the length of the wire, while robust distal insulation allows transseptal puncture at low power settings.
ElectroWire also states that, despite its 0.032-inch labelled diameter—which facilitates broad compatibility with various transseptal devices—the LightningWire is stiffer than the market-leading 0.035-inch guidewire, supporting efficient transseptal delivery of therapy devices.
The LightningWire’s activation cable connects to separately cleared electrosurgical generators and puts control of radiofrequency energy in the operator’s hands on the sterile field. The release adds that, having been designed for compatibility, LightningWire technology is positioned to bring value to all procedures in the rapidly growing transseptal access systems market—including catheter ablation for atrial fibrillation (AF), left atrial appendage occlusion, and transcatheter mitral valve repair and replacement.
“I am extremely excited to use the new LightningWire,” commented James Stewart (Piedmont Atlanta’s Marcus Heart Valve Center, Atlanta, USA). “The ability to cross the septum in a precise location using the transseptal catheter of my choice and then deliver bulky equipment into the left side of the heart should streamline our left-sided procedures tremendously.”
“Safe, effective and efficient transseptal access is critical in the electrophysiology space,” added William Brabham (Lexington Medical Center, Lexington, USA). “LightningWire meets all of these needs in a versatile device that can be used across industry platforms. It also has the potential to add cost savings for health systems as the economics of these important procedures evolve.”
ElectroWire says it looks forward to immediate commercialisation of the LightningWire system in a limited market release. The company is also currently raising capital.
“ElectroWire was founded to set a new standard for transseptal access and device delivery,” said ElectroWire founder Robert Leonardi. “We think we’ve done that with our LightningWire technology, which we expect to benefit patients, their physicians, and the hospitals and ambulatory surgery centres where transseptal procedures are done.”
