Spectranetics has announced receiving CE mark approval for its TightRail Rotating dilator Sheath platform for mechanical cardiac lead extraction procedures.
The announcement includes TightRail and a companion product: TightRail Mini rotating dilator sheath. The Mini is designed to gain vascular access, dilating heavily fibrosed and calcified tissue.
The new platform, the company announced, will be used to treat patients at facilities in Europe that are participating in Spectranetics’ initial limited launch.
SightRail Manual dilator sheath, a partner platform, was awarded the CE mark in April and features visual indicators that show bevel orientation and tip alignment, supplementing fluoroscopy as a means to determine position and orientation.
A company release states that these new platforms represent Spectranetics’ entry into the mechanical extraction device market, complementing its laser-based technology for cardiac lead extraction.
Spectranetics debuted TightRail at the Heart Rhythm Society’s 35th Annual Scientific Sessions in San Francisco, USA. The company announced that over 200 physicians participated in the “hands-on” solutions experience hosted by Spectranetics. TightRail will also be showcased at Cardiostim/EHRA Europace (18–21 June, Nice, France).