Spectranetics receives FDA clearance for its new VisiSheath Dilator Sheath device

SpectraneticsDec 3 2009

Spectranetics Corporation (Nasdaq: SPNC) today announced it has received Food and Drug Administration (FDA) 510(k) clearance for its new VisiSheath^TM 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.

Leads are insulated wires connecting pacemakers and defibrillators to the heart that can become infected or non-functional over time. The Heart Rhythm Society Expert Consensus on Facilities, Training, Indications and Patient Management issued earlier this year recommends lead removal following such complications. 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.”