CAUTION: This device is restricted to use by or on the order of a physician. Refer to the Instructions for Use for a complete listing of the Indications, Contraindications, Warnings, Precautions, Adverse Events, and Procedural Steps.

Indications for Use

The Spur is indicated for treatment of de novo or restenotic infrapopliteal lesions, with reference vessel diameters ranging from 2.5 – 4.5mm, prior to treatment with a commercially available drug coated balloon.

Intended Use

The Spur is intended to treat de novo or restenotic lesions in the infrapopliteal arteries to prepare the vessel for treatment with a commercially available drug coated balloon to enhance drug absorption.

Contraindications

The Spur is not intended for use in coronary and cerebral vasculature.

Warnings

• Do not use the device past the expiration date on the label. Use of expired products may result in patient injury.
• Inspect the device packaging prior to use. Do not use the device if the device packaging has been damaged or if sterility has been compromised. Damaged product could result in patient injury.
• Ensure the Spur is used with appropriately sized ancillary devices as listed in the section below. Failure to do so could result in inadequate device performance or patient injury.
• Remove excess slack from the catheter (outside of the patient) to ensure the Spur is recaptured appropriately.
• If an inability to inflate or maintain balloon pressure occurs, remove the device and use a new one.
• Do not use excessive force or torque (more than 1 full turn) on the catheter as this could result in damage to the device and result in patient

Precautions

• • This device should only be used by physicians experienced in interventional vascular procedures.
  • The system is intended for single (one) use only. DO NOT re-sterilize and/or reuse.
  • Inflate the balloon according to the balloon compliance chart. Balloon pressure should not exceed the rated burst pressure (RBP).
  • Use only the recommended contrast medium to inflate the balloon to ensure adequate delivery.
  • Perform all device manipulations under adequate fluoroscopy.
  • Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. If resistance is met, determine the cause of the resistance before proceeding.
  • Do not attempt to straighten a catheter if the shaft has become bent or kinked. Instead prepare a new catheter.
  • During the procedure appropriate anticoagulant therapy must be provided to the patient as needed. Antiplatelet therapy should be prescribed post procedure in accordance with the treating physicians routine practice for endovascular procedures.

Adverse Events

The following events are potential adverse effects associated with standard catheter-based peripheral interventions:

• Anemia;
• Edema;
• Hematoma;
• Peripheral arterial reocclusion;
• Peripheral artery dissection;
• Peripheral artery recoil;
• Pseudoaneurysm;
• Radiocontrast nephropathy;
• Vascular access site pseudoaneurysm;
• Vasospasm;
• Vessel perforation;
• Occlusion;
• Sepsis/Infection;
• Additional intervention;
• Short term hemodynamic deterioration;
• Stroke;
• Death;
• Heart attack;
• Vessel rupture;
• Hemorrhage;
• Pain or tenderness;
• Embolization;
• Arrhythmia;
• Shock.

©2024 Reflow Medical, Inc. All rights reserved. Reflow Medical, Spur and The Pulse of Medical Ingenuity are registered trademarks or trademarks of Reflow Medical, Inc. This device is restricted to use by or on the order of a physician. Refer to the Instructions for Use for a complete listing of the Indications, Contraindications, Warnings, Precautions, Adverse Events, and Procedural Steps.