Important Safety
Information.
Rx Only. Intended for U.S. healthcare professionals. Consult the Instructions for Use for each device for complete indications, contraindications, warnings, precautions and potential adverse events.
Launch copy is supplied and approved by Kaneka regulatory. Text below is taken from current Kaneka labeling and marketing materials.
i-ED COIL System
Indications for use
The i-ED COIL System (i-ED COIL and EDG v4) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The i-ED COIL System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
Contraindications
- Patients with serious thrombocytopenia or abnormal disability in blood coagulation
- Patients with hypersensitivity to platinum and/or tungsten
- Patients with pacemakers or implantable cardioverter defibrillators
- Patients with dissecting aortic aneurysms
Warnings
- For single use only. Do not re-use. Do not resterilize.
- Do not use the i-ED COIL if the device itself or its packaging is found damaged.
- Do not use the product after the "Use-by" date specified on the product label.
- The i-ED COIL was designed and tested for use with the EDG v4.
Potential adverse events
Device failures, adverse events and complications may include migration, breakage, delivery failure, hematoma, vascular injury, stroke, infection and complications from X-ray fluoroscopy exposure.
Consult the full Instructions for Use for complete safety information. Rx Only.
SurfRider 13 Microcatheter
Indications for use
The SurfRider 13 Microcatheter is intended for the introduction of interventional devices, such as embolic coils, or diagnostic agents into the neurovasculature. Rx Only.
Warnings
This device is intended for single use only. Do not resterilize or reuse. Resterilization and/or reuse may compromise the structural integrity of the device and/or increase the risk of contamination or infection leading to device failure and/or cross-infection and patient injury, illness or death. After use, dispose of the device in accordance with hospital and/or local government policy.
See package insert for complete indications, contraindications, warnings and instructions for use.
WaveSelect 1014 Guidewire
Indications for use
The WaveSelect Wire is intended for use in guiding microcatheters to the neurovasculature. WaveSelect facilitates the delivery of embolic devices for the endovascular treatment of brain aneurysms and other neurovascular conditions.
Refer to the WaveSelect Instructions for Use for contraindications, warnings, precautions and potential adverse events. Rx Only.
Toro 88 Superbore Catheter
Indications for use
The Toro 88 Superbore Catheter is indicated for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.
Warnings
Contents supplied STERILIZED using ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your representative. For single 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.
See package insert for complete indications, contraindications, warnings and instructions for use. Toro Neurovascular is a registered trademark in the U.S.