Indications, safety, and warnings Apollo™ Onyx™ delivery microcatheter &
Marathon™ flow directed microcatheter

INDICATIONS FOR USE

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.

The Apollo™ Onyx™ delivery micro catheter is intended to access the neuro vasculature for the controlled selective infusion of the Onyx™ liquid embolic system (LES).

CAUTION

1. Apollo™ Caution: U.S. federal law restricts the sale, distribution and use of this product to physicians or as prescribed by a physician. This product is for the exclusive use by medical specialists experienced in angiographic and percutaneous neurointerventional procedures.
2. Marathon™ Caution: Federal (USA) law restricts this device to sale, distribution, and use by or on the order of a physician. This device should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures.

PRECAUTIONS

Apollo™ Onyx™ Delivery Micro Catheter

• 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™ Onyx™ delivery micro catheter 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.
• 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™ Onyx™ delivery micro catheter has a hydrophilic coating on the outside of the catheter which must be kept hydrated.
• This catheter is 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.
• Navigating or repositioning the catheter while it is in a wedged position or with vessels that are in vasospasm may cause premature tip detachment.
• 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™ Onyx™ delivery micro catheter is a flow directed micro catheter that can optionally be used with hydrophilic, 0.010” or less sized guidewires. The Apollo™ Onyx™ delivery micro catheter is not compatible with non-hydrophilically coated guidewires or guidewires greater than 0.010” in diameter.
• It is recommended that the Apollo™ Onyx™ delivery micro catheter be used with an appropriately sized guiding catheter which allows adequate clearance (minimum internal diameter of 0.053” or 1.35mm).
• 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.
• If catheter entrapment is suspected, 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.

Marathon™ Flow Directed Micro Catheter

• Prior to use, carefully examine the Marathon™ and its packaging to verify that they have not been damaged during shipment.
• Prior to use, all accessory devices and agents should be fully prepared according to the manufacturer’s instructions.
• Always monitor infusion rates when using this catheter.
• The Marathon™ has a hydrophilic coating on the outside of the catheter which must be kept hydrated.
• This catheter is 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.
• Because the Marathon™ may be easily advanced into narrow, selective vasculature, repeatedly verify that the Marathon™ has not been advanced so far as to interfere with its removal by slightly withdrawing the catheter before each infusion.
• 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 Marathon™ is a flow directed micro catheter that can optionally be used with hydrophilic, 0.010” or less sized guidewires. The Marathon™ is not compatible with non-hydrophilically coated guidewires greater than 0.010” in diameter.
• It is recommended that the Marathon™ be used with an appropriately sized guiding catheter which allows adequate clearance (minimum internal diameter of 0.053” or 1.35mm).

CONTRAINDICATIONS

• The Marathon™ Flow Directed Micro Catheter is contraindicated when, in the medical judgment of the physician, use of such product may compromise the patient’s condition.
• The Marathon™ Flow Directed Micro Catheter is contraindicated for neonatal and pediatric use.
• The Apollo™ Onyx™ delivery micro catheter is 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.

POTENTIAL COMPLICATIONS

Potential complications include, but are not limited to:

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

WARNINGS

Apollo™ Onyx™ Delivery Micro Catheter

• 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.
• 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. Remove the catheter and 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. 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.
• Leave a gap between the Onyx™ LES reflux and the proximal marker band. Excessive reflux may result in difficult catheter removal.
• Do not reposition catheter after start of Onyx™ LES injections as this could lead to unintended and undetectable detachment and/or proximal embolization.
• Avoid pauses of greater than 2 minutes between injections. Prolonged pauses between Onyx™ LES injections may result in occlusion of the Apollo™ Onyx™ delivery micro catheter which may lead to leakage from the detachment zone.
• The detachable tip does not contain a proximal fluoroscopic marker band and therefore may not be able to be visualized following tip detachment if the distal marker band is embedded in the Onyx™ LES cast.
• Handle the Apollo™ Onyx™ delivery micro catheter with care.
• The catheter may leak from the distal tip coupling if the coupling is moved or damaged during handling

Marathon™ Flow Directed Micro Catheter

• 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.
• Do not “over-shape” the catheter to achieve the desired shape angle. Over-shaping can lead to catheter kink or prolapse.
• 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.
• 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.