Spectranetics Announces FDA Clearance of VisiSheath™ Dilator Sheath, New Lead Management Device

Enhanced Visibility and Performance Features Help Physicians Dilate Scar Tissue Surrounding Problematic Cardiac Leads Requiring Removal

Spectranetics Corporation announced it has received Food and Drug Administration (FDA) 510(k) clearance for its new VisiSheath™ Dilator Sheath device.

This expands the market for VisiSheath, which recently also received CE Mark approval in Europe. The VisiSheath Dilator Sheath may be used alone as an independent sheath for dilating tissue surrounding cardiac leads, or as an enhanced outer support sheath in conjunction with compatible inner sheaths such as Spectranetics’ Laser Sheath (SLS® II), a laser-based system for removing problematic pacing and defibrillator leads.

The VisiSheath Dilator Sheath is an enhanced tool to help physicians free cardiac leads from binding scar tissue that makes removal challenging by dilating the affected area. The VisiSheath device employs unique gold-coated steel marker bands to provide physicians with more than 200 percent better fluoroscopic visibility of the device tip than standard Teflon® or polypropylene sheaths. An advanced multi-layer construction and robust tip design deliver high performance for navigating over leads and dilating tissue.

The first human use of the VisiSheath device took place in Sweden in a laser-assisted lead removal procedure performed by Dr. Charles Kennergren, Associate Professor of Cardiothoracic Surgery at the Sahlgrenska University Hospital in Gothenburg. Dr. Kennegren commented, “VisiSheath’s fluoroscopic visibility is excellent. I found the device especially useful in supporting the laser sheath through the subclavian vein, reducing friction from the clavicle and increasing the tactile feel when maneuvering the laser sheath. For physicians that do not use the laser sheath, I believe this device will provide a nice, high-performance alternative to existing simple plastic sheaths.”

Following initial introduction of VisiSheath into the U.S. market, Dr. Bruce Wilkoff, Director of Cardiac Pacing and Tachyarrhythmia Devices at Cleveland Clinic, utilized it as an outer sheath for the SLS II laser sheath in a laser-assisted lead removal procedure at Cleveland Clinic. Dr. Wilkoff stated, “It is valuable for extraction sheaths to be visible on fluoroscopy and to provide for torque control. These characteristics favor safe advancement of extraction sheaths through fibrotic tissues.”

Both Dr. Kennergren and Dr. Wilkoff are members of the physician medical advisory board for Spectranetics.

More than two million Americans rely on a pacemaker or defibrillator to regulate their heartbeat. These devices rely on cardiac leads to deliver electrical impulses to the heart and detect the heart’s electrical activity. Physicians are recommended to remove cardiac leads when complications occur, such as infection or malfunction. Spectranetics’ excimer laser technology offers a safe means to remove cardiac leads by using pulsed bursts of ultraviolet (UV) light energy to break down scar tissue holding leads in place, thereby enabling effective removal. The newly FDA-cleared VisiSheath Dilator Sheath device will complement the laser-based system as an outer support sheath. Additionally, it will offer a non-laser option to mechanically dilate scar tissue for physicians who do not use laser assistance to manage all of their patients with lead complications.