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Spectranetics obtains FDA approval for two mechanical lead extraction devices

US-based Spectranetics has obtained the US Food and Drug Administration (FDA) approval for the TightRail rotating mechanical sheath platform and the SightRail manual dilator sheath platform.

The two new mechanical lead extraction platforms expand physicians’ options for safe removal of cardiac leads. Each platform features innovative designs for mechanical extraction aimed at providing total lead management solutions.

The TightRail rotating mechanical sheath platform features an advanced forward-facing dilating blade that remains shielded until activated. For efficient dilation, the tip feature rotates in both directions. For procedural safety, the physician controls when the blade is exposed.

Combining unprecedented shaft flexibility and column strength, the TightRail platform helps physicians safely navigate the vasculature during cardiac lead extraction procedures.

The CE-Marked SightRail manual dilator sheath platform has 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.

Spectranetics CEO Scott Drake noted that physicians consistently emphasize the need for the right tool at the right time for lead management.

"By providing a broader range of clinical solutions, our goal is to continue to enable safe, predictable outcomes in lead management.

"Our confidence in the long-term strength of this business continues to be driven by the launch of our mechanical tools portfolio and increasing contribution from our sales force expansion," Drake added.

With the TightRail rotating mechanical sheath platform and the SightRail manual dilator sheath platform, Spectranetics is now entering into the mechanical extraction device market.