Aspiration + TipTech


eNVac™ Aspiration Catheters are variable stiffness, large diameter single lumen catheters that provide a unique combination of durability, navigability and pushability to remove thrombus from the vasculature1,2.

The catheters are manufactured with proprietary combinations of polymers, braids, and coils customized for each catheter size and designed to provide the appropriate amount of stiffness for pushability and softness.

The outer surface of the eNVac™ Aspiration Catheter has a hydrophilic coating to reduce friction in the vessel for excellent maneuverability. The soft distal tip has a radiopaque marker to aid in positioning and navigation through the vessel1.

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Features and Benefits

  • 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 location1,2.
  • Extremely Trackable
    Ideal combination of excellent trackability and a large lumen1,2.
  • Large Lumen
    Empower your choice of aspiration sources up to -29.2 inHg (-98.9kPa) vacuum pressure1,3.
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  • Coil + Braid Construction
    Resists kinking even in extreme tortuosity.
    Coil + braid combined with engineered polymer transitions provide support, pushability, and distal tracking through tortuous vessels1.
  • Slick Hydrophilic Coating
    The latest generation of covalently bonded hydrophilic coating technology.
  • Long Lengths
    Catheter working lengths of up to 150cm with the .044 inch and 132cm with the .060 inch and .072 inch sizes allow for a variety of catheter combinations.
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This product is not available in all countries or regions and is not available in the USA. This product and information provided is for use by a Healthcare Professional only, please contact your NeuroVasc Technologies representative for details regarding product availability.

Facts about Stroke


Stroke is the leading cause of serious long-term disability in the USA, and the 2nd leading cause of death worldwide. According to AHA statistics, there are about 795,000 new strokes per in the USA alone resulting in 146,383 deaths7,8.

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people living globally
who have experienced
a stroke8
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New strokes every year8
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Strokes occur in people
<70 years old9
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People die from a
stroke every year8
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People >25 yrs will
experience a stroke
in their lifetime10

1 TR20-022
2 TR20-023
3 IFU-031, see product labeling supplied with each device for additional information
7 Virani SS, Alonso A, Benjamin EJ, et al.; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics – 2020 Update. Circulation, 2020 Mar 03;141:e139-e596.
8 GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol, 2019;18:439-58.
9 World Stroke Organization. Global Stroke Fact Sheet. These values have all been extracted from the Global Burden of Disease Stroke Statistics Worldwide for the year 2016.
10 V. Feigin et al. Global, Regional, and Country-Specific Lifetime Risks of Stroke, 1990 and 2016. New Engl J Med 2018;379:2429-2437

INTENDED USE / INDICATIONS FOR USE
The Envac™ Aspiration Catheter is intended for use in introduction of interventional devices and infusion of diagnostic or therapeutic agents and
removal/aspiration of emboli and thrombi from selected vessels in the arterial vasculature, including the peripheral and neuro vasculatures.
The Envac™ Aspiration Catheter is indicated for general intravascular use, including in the peripheral and neuro vasculatures.
The Envac™ Aspiration Catheter is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large
vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of
symptom onset.
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 the Envac™ catheter 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 the lumen of the catheter is occluded as this may result in catheter damage or patient injury.
• Do not exceed -29.2 inHg (-98.9kPa) vacuum pressure.
• 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.
• Envac™ is not designed to revascularize occlusions due to dissection or atherosclerosis.
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 Envac™ and/or between Envac™ and guidewire or microcatheter if used for navigation.
• 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 or separation of the catheter shaft.
• If the catheter becomes severely kinked, withdraw the entire system (Envac™ catheter, and guidewire and/or microcatheter if used for
navigation).
• 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 Envac™ 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 ADVERSE EVENTS
Possible complications of the use of the Envac™ catheter include, but are not limited to:

• Acute occlusion
• 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 brain and pulmonary
• Embolization (air, tissue, or thrombotic emboli)
• Hematoma at the site of entry
• Hemorrhage
• Hypotension/hypertension
• Inability to completely remove thrombus
• 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
• Radiation exposure that may lead to
cataracts, skin reddening or burns
• 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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