Pre-loaded in delivery catheter

One size for quick selection

Single adaptable filter for vessels ranging 3.5 mm – 6.0 mm

Secures onto any O.O14″ guidewire

Provides freedom to select the optimal guidewire for the procedure

Deploy anywhere on the O.O14″ guidewire

Provides complete control over filter positioning without compromising wire support and stability

Compatible with multiple atherectomy devices

Removes constraints around product selection and compatibility

Retrieval catheter with retractable tip technology

INTENDED USE

The WIRION is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris) while performing atherectomy in calcified lesions of the lower extremities. The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION may be used with commercially available 0.014" guide wires.

CONTRAINDICATIONS

• Patients with severe allergy to Heparin

• Patients with uncorrected bleeding disorder

• Patients in whom anticiagulant and antiplatelet therapy is contraindicated

WARNINGS

Only physicians who have received appropriate training and are familiar with the principles, clinical applications, complications and hazards commonly associated with interventional procedures should use this system.

• Intended for single-use only. Do not reuse. Reuse of this device may lead to its failure and subsequent patient injury, illness or death.

• Do not resterilize as this can compromise device performance and increase the risk of cross contamination due to inappropriate processing.

• If the delivery system is removed from the patient’s body prior to locking the filter on the guide wire, the delivery system must be discarded and a new delivery system used.

• The WIRION system is provided sterile. Do not use if the sterile barrier is damaged or if the package label is missing. If the sterile barrier is compromised, contact your Cardiovascular Systems representative.

• Refer to the instructions supplied with any interventional device to be used in conjunction with the System for their intended use, contraindications, warnings and precautions.

• The appropriate antiplatelet and anticoagulation therapy should be administered pre-and post-procedure to minimize the risk of embolism and thrombosis.

• Introduce and advance devices slowly to prevent air embolism or trauma to the vasculature.

• Do not use excessive force when attempting to cross the lesion with the System.

• Do not use the product after the “Use By” date specified on the package.

• The safety and effectiveness of the WIRION Embolic Protection System has been demonstrated in LE procedures with the following atherectomy devices: Jetstream, SilverHawk, TurboHawk, HawkOne, Phoenix, Pantheris, TurboPower, TurboElite and Diamondback. PRECAUTIONS

• Inspect the catheters prior to use (e.g., bends, kinks, integrity). Do not use if damaged.

• Maintain the sterile contents of the pouch in the sterile field during the procedure.

• Confirm angiographically that the vessel diameter is appropriate for treatment with the System.

• Confirm angiographically that there is a sufficient vessel length in which to place the Filter Unit, and to maintain adequate distance between the Filter Unit proximal side and the stent delivery device, the atherectomy system or other interventional devices.

• Ensure use of a guiding catheter or introducer sheath to allow system support during filter deployment; allow no more than 35cm length outside of the guiding catheter/sheath.

• Use a 6F to 8F guiding catheter with a 0.07” (1.78mm) to 0.088” (2.24mm) inner diameter respectively, or a 6F introducer sheath with a 0.079” (2mm) minimum inner diameter.

• Always use the System Retrieval Catheter to remove the Filter Unit with the guide wire. Pulling an open Filter Unit through a stent should be a last resort for retrieval as it may lead to entanglement of the filter with the stent.

• Always advance or retract the catheter slowly under fluoroscopic imaging. If resistance is felt and/or observed, determine the cause and take any necessary remedial action.

• Advancing or torqueing the catheters against resistance could result in vessel trauma.

• Use caution when advancing or retracting the catheters through a deployed stent as this may cause stent entanglement or stent dislocation.

• If blood flow through the filter is slow, the filter may be removed and replaced. However, at the operator’s discretion, the procedure may be completed before removing the device.

• If there is no blood flow through the filter, remove the filter, using the Retrieval Catheter. If further intervention is required, replace with a new system.

• If intervention is required in additional vessels, use a new System. 

Possible adverse events include, but are not limited to the following:

• Angina

• Bleeding complications

• Bradycardia or arrhythmias, including ventricular fibrillation or tachycardia Safety Sticker Rx Port Activating Handle Soft tip Pre-loaded Filter Tip retrieving knob Marker band Rx Port Handle Collecting tube

• Congestive heart failure

• Damage to or dislocation of the implanted stent(s)

• Death

• Detachment and/or implantation of a component of the device

• Drug reaction, allergic reaction to contrast media, medications or device materials

• Emergent surgery

• Embolization of air, tissue, thrombus or other embolic debris

• End organ ischemia, vessel thrombosis or spasm

• Hypotension/hypertension

• Infection (local or systemic)

• Myocardial infarction

• No-reflow resulting from reduced blood flow through the Filter Unit

• Puncture site complications (i.e., vessel occlusion, hemorrhage, hematoma, pseudoaneurysm or arteriovenous fistula)

• Renal insufficiency, kidney failure, hematuria

• Stroke/cerebrovascular accident (CVA), transient ischemic attack (TIA) or seizure

• Vessel damage, dissection, occlusion, aneurysm, perforation, rupture or injury

• Distal embolization or slow flow, loss of distal tibial runoff

• Amputation