US-based Spectranetics has obtained European CE Mark approval for its TightRail rotating dilator sheath platform that is designed to gain vascular access, dilating heavily fibrosed and calcified tissue.
Spectranetics claims that the TightRail rotating dilator sheath platform combines unprecedented shaft flexibility and column strength to help physicians safely navigate the vasculature during cardiac lead extraction procedures.
The company’s announcement includes TightRail and a companion product, TightRail mini rotating dilator sheath.
The TightRail rotating dilator sheath platform will be now used to treat patients at facilities in Europe that are participating in the company’ initial limited launch.
Following the completion of TightRail’s first in-patient case, Spectranetics introduced the TightRail earlier May 2014.
Spectranetics Lead Management business unit sales and marketing senior vice president Donna Ford-Serbu said that by providing a wider range of clinical solutions, the company is responding to a global need for innovative extraction options.
"Physicians are always looking for ways to serve their patient’s needs – we are committed to providing tools that extend life and ensure physicians are successful at every turn," Ford-Serbu added.
Spectranetics was awarded CE Mark approval for its SightRail manual dilator sheath, a partner platform, in April 2014. The SightRail manual dilator sheath features visual indicators that show bevel orientation and tip alignment, supplementing fluoroscopy as a means to determine position and orientation.
Image: Spectranetics’ TightRail rotating dilator sheath platform. Photo: Courtesy of The Spectranetics Corporation