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Tissue-dilating sheath receives FDA premarket clearance
The VisiSheath Dilator Sheath can be used independently or in combination with other compatible cardiac lead removal systems.
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Spectranetics has announced that its VisiSheath Dilator Sheath, indicated for the percutaneous dilation of tissue surrounding cardiac leads, has received 510(k) clearance from the FDA.
According to FDA documents, the VisiSheath can be used to dilate the scar tissue surrounding cardiac leads and to assist in the removal of indwelling catheters and other foreign objects. The VisiSheath device is also indicated for the introduction of intravascular catheters. The device is compatible with the Spectranetics Laser Sheath (SLS II) system, which uses a laser-based mechanism for the removal of scar tissue surrounding the cardiac lead.
The VisiSheath Dilator Sheath consists of a single-lumen polymer sheath that can be used independently or as an outer support for an inner sheath that can facilitate tissue dilation. Both ends contain radiopaque, gold-coated marker bands that can enhance the fluoroscopic visibility of the device tip by more than 200% when compared with standard polypropylene sheaths, according to a press release. To accommodate a variety of clinical scenarios, the VisiSheath device is offered in nine sizes composed of several combinations of diameters and lengths.
“It is valuable for extraction sheaths to be visible on fluoroscopy and to provide for torque control,” Bruce Wilkoff, MD, director of cardiac pacing and tachyarrhythmia devices at the Cleveland Clinic and a member of the physician advisory board of Spectranetics, said in a press release. “These characteristics favor safe advancement of extraction sheaths through fibrotic tissues.”
The VisiSheath Dilator Sheath has obtained CE Mark approval in Europe.