The Pantheris LV Catheter is a monorail (rapid exchange) device with an effective length of 110 cm, compatible with standard 7F sheaths and 0.014” guidewires. It consists of a lubricious coated torque shaft with a proximal handle assembly and an atraumatic distal assembly. The distal assembly of the catheter consists of an imaging assembly, a rotating cutter, an apposition jog, and a flexible, tiltable nosecone with a radiopaque fuel gauge. The distal end of the catheter includes an approximately 13 cm length guidewire lumen, accommodating standard 0.014” guidewires. The nosecone component of the catheter is 6 cm long. The catheter is sterilized by electron beam and is intended for single use only.
A sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of peripheral arteries. It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This device is not intended for use in the coronary, carotid, iliac or renal vasculature. This is a single-use device.