SpeedLyser® PRO™ Infusion System

PRO infusion System – Built for Dialysis Grafts and Fistulas

Designed to enhance patient safety, the SpeedLyser device helps reduce risk of embolism because of its effectiveness in uniformly delivering a lytic drug throughout the graft or fistula. It is the first system to combine the minimal invasiveness of micropuncture access with the efficiency of PRO infusion technology.

PRO slit technology along the catheter’s surface results in faster, more uniform distribution of lytic agent than with a conventional end-hole catheter, assuring effective lysis throughout the entire graft or fistula. For faster, more uniform drug delivery and efficient resolution of thrombosis, the SpeedLyser device delivers lytic agent directly into clots in only 1-2 seconds with a single 5-10 cc bolus, compared with the 3-5 minutes required using a conventional end-hole device.

Features:
  • PRO Slit Technology allows for faster, more uniform distribution of lytic agent
  • PRO slit design eliminates need to occlude inflow and outflow, as typically required with a conventional Lyse & Wait system
  • Coaxial interlocking catheters, with 3 French inner and 5 French outer components, designed with tapered tip for a smooth insertion and tracking over an .018” wire
  • User-friendly kit, packaged with all the components needed for an efficient graft lysis procedure

Important Risk Information

INDICATION FOR USE: AngioDynamics SpeedLyser Infusion Catheter Kit is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature CONTRAINDICATIONS: The SpeedLyser Infusion Catheter Kit is contraindicated for use in the coronary vasculature and is not intended for the infusion of blood or blood products. WARNINGS AND PRECAUTIONS: The SpeedLyser Infusion Catheter and kit components are supplied sterile and are intended for single use only. Do NOT reuse or resterilize these devices. The SpeedLyser devices should be used by physicians who have a thorough understanding of angiography and percutaneous interventional procedures. Refer to the product insert of the therapeutic solution for indications, contraindications, side effects and precautions. The SpeedLyser Infusion Catheter Kit is not intended for use with power injectors. CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician. POTENTIAL COMPLICATIONS: Adverse reactions may include, but are not limited to: vessel dissection or perforation, vasospasm, hemorrhage, hematoma, stroke, biocompatibility reaction, embolism, clotting, contrast extravasation, drug reaction, neurological deficits, pain, and tenderness.Indications, contraindications, warnings and instructions for use can be found in the instructions for use supplied with each device. Observe all instructions prior to use. Failure to do so may result in patient complications.

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