FDA approves Spectranetics dilator sheath device

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The FDA has granted 510(k) clearance for Spectranetics’ VisiSheath dilator sheath device, which recently received CE Mark approval in Europe.

According to the Colorado Springs, Colo-based company, the agency has indicated that 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, a laser-based system for removing problematic pacing and defibrillator leads.