FDA clears mechanical lead extraction devices

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Spectranetics announced US Food and Drug Administration (FDA) clearance of two new mechanical lead extraction platforms – the TightRail rotating mechanical sheath and the SlightRail manual dilator sheath – that expand physicians’ options for safe removal of cardiac leads. Each incorporates innovative designs for mechanical extraction aimed at providing total lead management solutions.

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

The SightRail manual dilator sheath platform features visual indicators that show bevel orientation and tip alignment, supplementing fluoroscopy as a means to determine position and orientation. A longer inner sheath gives physicians 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.

These new platforms represent Spectranetics’ entry into the mechanical extraction device market and complement the laser-based technology that established the company’s leading position in lead extraction.

Charles Love, professor of Medicine and director of Cardiac Rhythm Device Services at New York University Langone Medical Center, USA, has been performing extractions since 1988. “In my experience, removing cardiac leads requires skill, patience and the right tools,” says Love.


“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 (SVC).”

Love says that the utility of the TightRail mechanical sheath in aligning with the curves and bends characteristic of the superior vena cava. “Leads rarely take a straight course through the vasculature,” he says. “Having a flexible sheath that follows the curvature of the lead and maintains alignment with the lead is critical to successful extraction.”

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