FDA Clears Spectranetics TightRail and SightRail Mechanical Lead Extraction Devices

April 10, 2014—Spectranetics Corporation (Colorado Springs, CO) announced US Food and Drug Administration clearance of two mechanical lead extraction platforms for removal of cardiac leads.

According to the company, the TightRail rotating mechanical sheath platform combines shaft flexibility and column strength to help physicians safely navigate the vasculature during cardiac lead extraction procedures. The device incorporates a forward-facing dilating blade that remains shielded until activated. The tip rotates in both directions for efficient dilation. For procedural safety, the physician controls when the blade is exposed.

The SightRail manual dilator sheath platform has visual indicators that show bevel orientation and tip alignment, supplementing fluoroscopy to determine position and orientation. A longer inner sheath gives physicians an improved ability to grip and manipulate the device, especially when advancing and rotating. The SightRail sheath set has also received CE Mark approval for use in Europe.

In the company’s press release, Charles Love, MD, commented, “In my experience, removing cardiac leads requires skill, patience, and the right tools. Identifying bevel orientation can be challenging with fluoroscopy alone, so the visual direction offered by the SightRail sheath helps ensure proper sheath positioning and tip orientation when working in the superior vena cava.”

Dr. Love, who is Professor of Medicine and Director of Cardiac Rhythm Device Services at New York University Langone Medical Center in New York, New York, noted the utility of the TightRail mechanical sheath in aligning with the curves and bends characteristic of the superior vena cava. He stated, “Leads rarely take a straight course through the vasculature. Having a flexible sheath that follows the curvature of the lead and maintains alignment with the lead is critical to successful extraction.”