Catheters with TipTech


eNVoke Micro and Intermediate Catheters offer a broad range of access solutions for use in nearly any interventional procedure. A unique blend of coil, braid, and polymers provides catheter stability and flexibility to easily navigate tortuous anatomy. Our catheters are designed for delivery and re-sheathing of devices and to facilitate stent-retriever thrombectomy1,2.

Powered by its unique tip construction, TipTech is an innovation designed to optimize navigation/trackability through the vessel to the target location.

TipTech is designed to provide targeted softness to the catheter tip, enabling it to articulate and conform to the angle of the vessel and glide to the desired anatomy1.

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Features and Benefits

  • Unique Polymer Jacket, Braid, and Coil Combinations
    Our proprietary combinations of polymers, braids, and coils were customized for each catheter size and created to provide the appropriate amount of stiffness for pushability and softness.
  • Friction Reduction – Inside and Out
    Hydrophilic coating on the outer surface allows for ease of navigation through vessels and a PTFE liner on the inner surface provides controlled delivery of devices, therapeutic agents, or other catheters1.
  • Control
    The stability of the catheter enables delivery, deployment, and retrieval of compatible interventional devices, giving the user control every step of the way1,3.
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  • Multiple Lengths
    Wide range of lengths for different anatomies and approaches, up to 167cm for the microcatheters.
  • Durability
    Durable combination of materials and construction maintains catheter integrity in challenging models1.
  • Exceptional Navigability
    Variable stiffness catheters with precisely designed transition zones provide stability in the proximal shaft and flexibility at the tip resulting in exceptional navigation to the target location2.
  • Shapeable Tip
    The combination of Tip Shapeability and Retention allows for targeted catheter advancement in distal navigation and challenging vasculature1.
  • Multiple Softness Profiles
    Each diameter eNVoke Catheter is available in a variety of softness/stiffness profiles to fit a wide breadth of user preferences and procedural needs.
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This product is not available in all countries or regions. Pending FDA Clearance, Not Available for Sale in the United States. This product and information provided is for use by a Healthcare Professional only, please contact your NeuroVasc Technologies representative for details regarding product availability.

1 TR20-001
2 TR20-003
3 IFU-030, see product labeling supplied with each device for additional information on compatibility

INTENDED USE
The Envoke™ catheters are intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculatures.
CONTRAINDICATIONS
• None known.
WARNINGS
• Do not use if damage to the device is observed.
• Do not use if the product sterile barrier system or its packaging is compromised.
• This device is intended for single use only. Do not resterilize and/or reuse in multiple patients. Structural integrity, sterility and/or function may be impaired by resterilization or re-use.
• Never advance or withdraw an intravascular device against resistance until the cause of resistance is determined by fluoroscopy. Movement of the device against resistance could dislodge a clot, perforate a vessel wall, or damage the device.
• The catheter should be manipulated under fluoroscopy only. Do not attempt to move the catheter without observing the resultant tip response.
• Do not exceed 2070 kPA (300 psi) maximum recommended infusion pressure. Excess pressure may result in catheter damage or patient injury. Use of power injectors requires careful monitoring of catheter tip placement in the vasculature to avoid vessel damage.
• Do not exceed 317 kPa (46 psi) if lumen of catheter is occluded as this may result in catheter damage or patient injury.
• The safety and effectiveness of the device has not been established, or is unknown, in vascular regions other than those specifically indicated.
• This device is coated with a hydrophilc coating at the distal end of the device for a length indicated on the label. Please refer to Procedure section for further information on how to prepare and use this device to ensure it performs as intended. Failure to abide by the warnings in this labeling may result in damage to the device coating, which may necessitate intervention or result in serious adverse events.
PRECAUTIONS
• Carefully read these directions before using this product. Observe warning and safety precautions.
• The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard medical practice.
• The device should only be used by physicians experienced in angiographic and percutaneous interventional procedures, at medical facilities with the appropriate fluoroscopic equipment.
• Use device prior to “Use-by” date printed on label.
• Prevent exposure to temperatures in excess of 55°C. Exposure to temperatures above this temperature may damage device and accessories. Do not autoclave.
• To prevent thrombus formation and contrast media crystal formation, maintain a constant infusion of appropriate flush solution between guide catheter and microcatheter and between the microcatheter and guidewire.
• If flow through catheter becomes restricted, do not attempt to clear catheter lumen by infusion. Doing so may cause catheter damage or patient injury. Remove and replace catheter.
• Torqueing the catheter may cause damage which could result in kinking to separation of the catheter shaft.
• If an intraluminal device becomes lodged in the catheter, or if the catheter becomes severely kinked, withdraw the entire system (intraluminal device, catheter, and guiding catheter).
• The Shaping Mandrel is not intended for use inside the body. Ensure Shaping Mandrel is removed from the catheter prior to introduction into the RHV or other accessories.
• Use only a steam source to shape the catheter tip. Do not use other heat sources or the catheter may be damaged.
• Verify that the diameter of any guidewire or accessory device that is used is compatible with the inner diameter of the catheter prior to use.
• The Envoke™ catheter has a lubricious hydrophilic coating on the outside of the distal end.
• The coating must be kept hydrated in order to be lubricious.
• The coating is incompatible with solvents such as alcohols or cleaning agents. Avoid using alcohols, antiseptic solutions, or other solvents as these may damage the coating, which could affect device safety and performance.
• Avoid wiping the device with dry gauze as this may damage the device coating. Avoid excessive wiping of the coating.
• Avoid device insertion through a metal cannula or needle. Manipulation, advancement, and/or withdrawal through a metal device may result in coating material remaining in the metal device leading to adverse events such as embolization.
• Caution: Federal (USA) law restricts this device to sale, distribution and use by or on the order of a physician.
POTENTIAL COMPLICATIONS
Possible complications of the use of the Envoke™ catheter include, but are not limited to:
• Adverse reaction to antiplatelet/anticoagulation agents or contrast media
• Additional surgical Intervention
• Allergic reaction
• Aneurysm or pseudoaneurysm
• Aneurysm perforation or rupture
• Anesthesia complications
• Arteriovenous fistula
• Cerebral infarct
• Change in mental status
• Death
• Device deformation, collapse, fracture, or malfunction
• Edema, including braid and pulmonary
• Embolization (air, tissue, or thrombotic emboli)
• Hematoma at the site of entry
• Hemorrhage
• Hypotension/hypertension
• Infection
• Inflammation, including sterile inflammation or granulomas at the access site
• Intracranial hemorrhage including subarachnoid hemorrhage and hemorrhagic transformation
• Ischemia
• Myocardial embolism
• Myocardial infarct
• Neurological deficits including stroke and death
• New stroke/ cerebrovascular accident/ transient ischemic attack (TIA)
• Pain at the site of entry
• Post procedural bleeding
• Pulmonary embolism
• Pulmonary infarct
• Pseudoaneurysm
• Renal failure
• Respiratory failure
• Shock
• Stroke
• Thrombosis (acute and subacute)
• Tissue necrosis, transient or long-lasting
• Vascular thrombosis
• Vascular occlusion
• Vascoconstriction (Vasospasm)
• Vessel trauma, dissection, perforation, rupture, or injury

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