Baylis Medical Technologies today announced US Food and Drug Administration (FDA) 510(k) clearance and commercial launch of the PowerWire 14 radiofrequency (RF) guidewire, designed to facilitate the crossing of completely occluded native or stented peripheral vessels 3mm in diameter or greater.
A press release states that the PowerWire 14 RF guidewire is the first 0.014” RF-enabled crossing wire, offering physicians a smaller-profile option when navigating challenging occlusions. Building on the established PowerWire Pro RF guidewire platform, PowerWire 14 RF guidewire combines RF-assisted crossing capability with a 0.014” profile, providing an option for use in anatomies where precision and controlled advancement are critical.
PowerWire 14 RF guidewire is intended for use in both arterial and venous occlusions. According to Baylis Medical Technologies, early physician use suggests potential advantages in high-pressure systems and complex anatomies where a smaller wire profile may offer greater physician comfort when using RF-assisted technology.
The company notes that, when the energised tip of the PowerWire 14 RF guidewire contacts metal, RF delivery automatically terminates, helping support controlled advancement during in-stent crossing. This design feature assists physicians in managing challenging in-stent occlusions.
Laura Conquergood, chief executive officer of Baylis Medical Technologies, commented: “The launch of PowerWire 14 RF guidewire expands our RF puncture crossing portfolio with a 0.014” option, providing physicians with additional flexibility to select the wire profile that best aligns with vessel size, lesion characteristics, and procedural approach.”
