Spectranetics Announces FDA Clearance for Mechanical Lead Extraction Devices
Expands Cardiac Lead Extraction Portfolio to Include TightRail Rotating Mechanical Dilator Sheath and SightRail Manual Mechanical Dilator Sheath Set
The Spectranetics Corporation today announced FDA clearance of two new mechanical lead extraction platforms 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, M.D., Professor of Medicine and Director of Cardiac Rhythm Device Services at New York University Langone Medical Center, has been performing extractions since 1988. "In my experience, removing cardiac leads requires skill, patience and the right tools," said 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 pointed out the utility of the TightRail mechanical sheath in aligning with the curves and bends characteristic of the SVC. "Leads rarely take a straight course through the vasculature," he said.
"Having a flexible sheath that follows the curvature of the lead and maintains alignment with the lead is critical to successful extraction."
Spectranetics CEO Scott Drake sees the next-generation mechanical extraction devices as a welcome addition to the company's portfolio of lead extraction solutions. "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," said Drake. "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."
There are over seven million implanted cardiac devices globally. Each year, about 750,000 additional patients are implanted with these devices worldwide, translating to 1.5 million leads. It is estimated that in 2014, roughly 400,000 patients will meet indications for a lead extraction procedure.