Apollo™ Onyx Delivery Micro Catheter &
Marathon™ Flow Directed Micro Catheter Indications, Safety, and Warnings

INDICATIONS FOR USE

The Apollo^TM Onyx Delivery Micro Catheter is intended to access the neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.

The Marathon™ Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.

CAUTION

• Federal (USA) law restricts this device to sale, distribution, and by or on the order of a physician.
• These devices should be used only by physicians with a thorough understanding of angiography and/or percutaneous neurointerventional procedures.

PRECAUTIONS

• For Apollo™: Select tip size based on angioarchitecture. The detachment zone should never be distal to the last tortuous curve of the vessel. Refluxing over the detachment zone distal to the last tortuous curve may result in catheter entrapment. Do not place catheter such that the detached tip could interfere with patent vessels.
• Prior to use, carefully examine the Apollo™ or the Marathon™ and its packaging to verify that it has not been damaged during shipment. Do not touch or manipulate the catheter tip prior to use.
• Prior to use, all accessory devices and agents should be fully prepared according to the manufacturer’s instructions.
• For Apollo™: During navigation, check that the distal tip of the catheter is not kinked before passing the guidewire through it. Kinking or prolapsing of the catheter may result in unintended rupture of the catheter.
• Always monitor infusion rates when using the catheter.
• The Apollo™ and the Marathon™ have a hydrophilic coating on the outside of the catheter which must be kept hydrated.
• These catheters are not intended for use with chemotherapy agents.
• When the infusion catheter is in the body, it should be manipulated only under fluoroscopy. Do not attempt to move the catheter without observing the resultant tip response.
• For Apollo™: Navigating or repositioning the catheter while it is in a wedged position or with vessels that are in vasospasm may cause premature tip detachment.
• For Apollo™: Do not reposition catheter after start of Onyx injections.
• When performing angiography, it is recommended to use a 3cc syringe rather than a 1cc syringe to reduce the risk of catheter over-pressurization.
• The Apollo™ and the Marathon™ are flow directed micro catheters that can optionally be used with hydrophilic, 0.010” or less sized guidewires. The Apollo™ and the Marathon™ are not compatible with non-hydrophilically coated guidewires or guidewires greater than 0.010” in diameter.
• It is recommended that the Apollo™ and the Marathon™ be used with an appropriately sized guiding catheter which allows adequate clearance (minimum internal diameter of 0.053” or 1.35mm).
• For Apollo™: When withdrawing the catheter, monitor the distal tip under angiography. Pulling the catheter against significant resistance can cause patient injury. If significant catheter resistance is felt, refer to the precaution in the procedure section below for guidance.
• For Apollo™: If catheter entrapment is suspected (with any embolic agent), fast catheter retrieval technique may result in catheter shaft separation and potential vascular damage. Follow catheter retrieval instructions at the end of instructions for use.
• If catheter entrapment is suspected (with any embolic agent), fast catheter retrieval technique may result in catheter shaft separation and potential vascular damage.

CONTRAINDICATIONS

• The Apollo™ Onyx Delivery Micro Catheter and the Marathon™ Flow Directed Micro Catheter are contraindicated when, in the medical judgment of the physician, use of such product may compromise the patient’s condition.
• Not intended for use in the coronary vasculature.
• The Apollo™ Onyx Delivery Micro Catheter and the Marathon™ Flow Directed Micro Catheter are contraindicated for neonatal and pediatric use.

POTENTIAL COMPLICATIONS

Potential complications include, but are not limited to, the following:

• Puncture site hematoma
• Pain and tenderness
• Vessel perforation
• Thrombolytic episodes
• Vessel spasm
• Neurological deficits including stroke and death
• Hemorrhage
• Vascular thrombosis

WARNINGS

• For Apollo™: Not intended for use with embolization particles, detachable coils or Onyx HD500.
• For Apollo™: Do not steam shape the tip of the micro catheter. Steam shaping the catheter tip may cause damage to the detachment zone and unintended detachment.
• For Apollo™: Do not use a cannula or needle to introduce the end of the catheter into a connector. Insertion of a cannula or needle may cause damage to the detachment zone and result in unintended detachment.
• For Apollo™: Always handle the distal end of the catheter with care to avoid damage to the detachment zone and unintended detachment.
• Infusion pressure with this device should not exceed 690 kPa/100 psi. Pressure in excess of 690 kPa/100 psi may result in catheter rupture, possibly resulting in patient injury.
• If flow through the catheter becomes restricted, do not attempt to clear the device by high pressure infusion. Either remove the catheter to determine the cause of the obstruction or replace it with a new catheter. Excessive pressure may cause catheter rupture, possibly resulting in patient injury.
• Never advance or withdraw an intraluminal device against resistance until the cause of the resistance is determined by fluoroscopy. Excessive force against resistance may result in damage to the device or vessel perforation.
• When injecting contrast for angiography, ensure that the catheter is not kinked, prolapsed or occluded. Remove excess slack in the catheter to reduce the potential for catheter kink or prolapse.
• Verify catheter integrity prior to re-inserting guidewire or injecting embolic material to prevent vascular damage or unintended embolization. Catheter integrity is verified by angiographically confirming that contrast agent is exiting only from the catheter tip while viewing the entire distal section of the catheter.
• For Apollo™: Regardless of the liquid embolic being used, leave a gap between the reflux and the proximal marker band. Excessive reflux may result in difficult catheter removal.
• This device is supplied STERILE for single use only. Do not reprocess or re-sterilize. Reprocessing and re-sterilization increase the risks of patient infection and compromised device performance.
• For Apollo™: Verify catheter integrity prior to re-inserting guidewire or injecting embolic material to prevent vascular damage or unintended embolization. Catheter integrity is verified by angiographically confirming that contrast agent is exiting only from the catheter tip while viewing the entire distal section of the catheter.
• For Marathon™: Do not “over-shape” the catheter to achieve the desired shape angle. Over-shaping can lead to catheter kink or prolapse.
• For Marathon™: The stylet (supplied with some models) is not to be used as a guidewire. The stylet should never be manipulated within the catheter. Do not advance the stylet beyond the tip of the catheter. Use of the stylet as a guidewire could cause damage to the catheter and/or injure the patient.
• For Marathon™ Steam Shaping Mandrel:
      - Shaping Mandrel is not intended for use in the human body.
      - Use only a steam source to shape the catheter tip. Do not use other heat sources.
      - Prior to use, inspect the catheter tip for any damage that may have resulted from shaping. Do not use a catheter that has been damaged in any way. Damaged catheters may rupture causing vessel trauma or tip detachment during steering maneuvers.