Micro catheters

Plato™ 17 micro catheter

<p>Plato™ 17 micro catheter introduces therapeutic devices, infuses diagnostic agents, and delivers embolization materials in neuro and peripheral vasculatures.</p>

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Indications, Safety, and WarningsCautionFederal law (USA) restricts this device to sale by or on the order of a physician.Indications for UseThe Plato 17 Microcatheter is intended for the introduction of therapeutic devices, infusion of diagnostic agents, such as contrast media, and delivery of embolization materials to the peripheral and neuro vasculature systems. The Plato 17 Microcatheter is not intended for use in the coronary vasculature.ContraindicationsNone known.CompatibilityDiagnostic agents, therapeutic devices, and embolization materials should be used in accordance with information provided by their respective manufacturer and labeling. The Plato® 17 Microcatheter should only be used with devices that are compatible with 0.017-inch inner diameter microcatheters per the manufacturer’s instructions. The Plato® 17 Microcatheter should only be used with large bore catheters that are compatible with 0.028-inch (2.1F) outer diameter microcatheters. Interface compatibility with the catheter should be carefully considered before use. The Plato® 17 Microcatheter has been verified to be compatible for use with polyvinyl alcohol (PVA) embolic particles up to 300µm-500µm in size. Consult table below.

Model

Working Length

(cm)

Maximum Guidewire Diameter inch (mm)

Minimum Guiding Catheter ID

inch (mm)

Plato 17

160

0.014 in (0.36mm)

0.038 in (1.00mm)

Potential ComplicationsPotential complications include, but are not limited to: access site complications, allergic reaction, aneurysm rupture or perforation, death, emboli (air, foreign body, plaque, tissue, thrombus), hematoma, hemorrhage, infection, ischemia, nerve injury, neurological deficit, pain at insertion site, pseudoaneurysm, respiratory distress, seizure, stroke, transient ischemic attack, vessel dissection, vessel injury, vessel occlusion, vessel perforation, vessel rupture or perforation, vessel spasm, and vessel thrombosis.Warnings and Precautions

The microcatheter system should be used only by physicians with a thorough understanding of angiography and/or percutaneous interventional procedures.

Carefully inspect the microcatheter prior to use to verify the shape, size and condition are suitable for the specific procedure and for any damage such as kinks or bends. Any damage may decrease performance resulting in patient injury or death.

For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

The Plato^® 17 Microcatheter is supplied STERILE and non-pyrogenic for single use only. Inspect the pouch prior to use for any gaps in sterile barrier such as faulty seals or holes. Do not use if sterile barrier is damaged or package is opened. Do not reprocess or re-sterilize. Reprocessing or resterilizing increases the risks of patient infection and compromises device performance.

Use only therapeutic/interventional devices, diagnostic agents, and embolization materials that have been cleared or approved for use in the intended target anatomy.

Do not exceed the maximum injection pressure of 300 psi or the maximum allowable dynamic pressure of 300 psi.

Use the microcatheter prior to the “Use By” date specified on the package.

Avoid excessive wiping and wiping the device with dry gauze as this may damage the device coating.

Avoid using alcohol, antiseptic solutions, or other solvents to pre-treat the device because this may cause unpredictable changes in the coating, which could affect the device safety and performance.

Avoid pre-soaking devices for longer than instructed, as this may impact the coating performance.

Never advance or withdraw any device within the catheter against resistance until the cause of the resistance is determined.

Discontinue use of microcatheter for infusion if increased resistance is noted. Resistance indicates possible blockage. Remove and replace blocked microcatheter immediately. Do not attempt to clear blockage by over-pressurization. Doing so may cause the microcatheter to rupture, resulting in vascular damage or patient injury.

The Plato^® 17 Microcatheter should be manipulated under fluoroscopy. Do not attempt to move the microcatheter without observing the resulting tip response. Movement of the microcatheter against resistance may result in damage to the microcatheter or injury to the patient.

Limit exposure to X-ray radiation doses to patients and physicians by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors when possible.

Exchange microcatheters frequently during lengthy procedures that require extensive guidewire manipulation or multiple guidewire exchanges.

The Plato^® 17 Microcatheter was evaluated for compatibility with agents that include contrast media, saline, dimethyl sulfoxide (DMSO), ethanol, and ethiodized oil (e.g. lipiodol). The use of these catheters for delivery of solutions other than the types that have been tested for compatibility has not been evaluated.

The Plato^® 17 Microcatheter was evaluated for the delivery of therapeutic devices, such as stents.

The Plato^® 17 Microcatheter is not compatible with stent retrievers. Use of these devices with the Plato^® 17 Microcatheter could result in device damage that may lead to catheter failure and to enhance embolic risks.

The Plato^® 17 Microcatheter was evaluated for the delivery of embolization materials, such as embolic coils, embolic particles, and liquid embolic agents, including Onyx. The use of these catheters for delivery of other embolization materials has not been evaluated.

The Plato^® 17 Microcatheter has not been evaluated for compatibility with embolization materials containing n-BCA, such as Trufill. Use of these devices with the Plato^® 17 Microcatheter could result in device damage that may lead to catheter failure and patient injury.

Plato® 17 Microcatheters are not safe for use in or near Magnetic Resonance Imaging (MRI) equipment.

Features

Proprietary microfabricated design permits thousands of transition zones to navigate complex neuro and peripheral vasculatures

Scientia Plato Micro Catheter annotated image

1. Strain relief minimizes kinking

2. Engineered polymers align with specific cut geometry to optimize flexibility and support

3. Full-length microfabricated nitinol shaft balances torsional strength, push, and trackability

4. Overall length (160cm)

5. Hydrophilic coating (90cm)

6. 2.1F OD

7. Distal cut geometry provides for tip softness and stability

8. 3cm length from marker band to tip

9. Stainless steel distal coil ensures maximum softness

10. 1.7F OD

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