FDA Clears Cardiac Lead Extraction Technology from Spectranetics

Spectranetics Corp. received U.S. Food and Drug Administration clearance of two new mechanical cardiac lead extraction devices.

The TightRail rotating mechanical sheath platform combines shaft flexibility and column strength to help physicians safely navigate the vasculature during cardiac lead extraction procedures. A 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.

The new platforms represent the Colorado Springs, Colo.-based company’s entry into the mechanical extraction device market and complement its laser-based technology.

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 said the TightRail mechanical sheath helps 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,” Drake said. “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.”

According to figures cited by the company, there are more seven million implanted cardiac devices globally. Each year, about 750,000 additional patients are implanted with the 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.

Spectranetics develops single-use medical devices used in minimally invasive procedures within the cardiovascular system.

The company’s vascular intervention products include a range of laser catheters for ablation of blockages in arteries above and below the knee. The company also dells support catheters to facilitate crossing of peripheral and coronary arterial blockages, and retrograde access and guidewire retrieval devices used in the treatment of peripheral arterial blockages, including chronic total occlusions. In addition, Spectranetics sells aspiration and cardiac laser catheters to treat blockages in the heart. The firm’s lead management product line includes excimer laser sheaths, mechanical sheaths and accessories for the removal of pacemaker and defibrillator cardiac leads.