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3-in-1 Thrombectomy
Aspiration + Maceration + Transportation
The AspirexTM Mechanical Aspiration Thrombectomy System offers a 3-in-1 mechanism of action designed to aspirate, macerate, and transport clot out of the vessel.
true
Complete Mechanism
of Action
ADVANCED
ASPIRATION
Internal helix rotates at 40,000 – 60,000 RPMs creating powerful suction at the catheter tip, aspirating clot through wall-apposed side window(s)
CONTINUOUS MACERATION
Clot is macerated by the internal helix as it enters the catheter, and is continuously macerated as it travels through the catheter to help mitigate clogging
MECHANICAL TRANSPORATION
Internal helix helps transport clot through the catheter, out of the vessel
Small Footprint & Simple Set-Up
- No Warm-up or repeated catheter clean-out required
- Plug-and-play capital component
Recanalization of an Acute Iliofemoral Deep Vein Thrombosis Using the Aspirex™ 10F Catheter
Dr Michael Lichtenburg, Chief Medical Officer, Karolinen Hospital, Arnsberg, Germany
Venogram demonstrated complete thrombotic occlusion of the left iliac vein (figure 1). Mechanical Thrombectomy was performed with the 10F Aspirex™ Catheter (figure 2). At the 3-month clinical follow-up visit, the patient's venous outflow was shown to be symptom-free. Venous outflow was shown to be possessive on the treated side.
*This clinical experience is presented for informational purposes only. The results from this case study may not be predictive for all patients. Individual results may vary depending on a variety of patient specific attributes.
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The Aspirex™ Thrombectomy System is indicated for the removal of acute emboli and thrombi from vessels of the peripheral venous system.
The Aspirex™ Thrombectomy System is not for use in the vessels of the cardiac, pulmonary, coronary and neurovasculature. Please consult product labels and instructions for use for indications, contraindications, hazards, warnings, and precautions.
BD-56967
Aspirex™ Mechanical Aspiration Thrombectomy System
Indication for Use
The Aspirex™ Mechanical Aspiration Thrombectomy System is indicated for the removal of acute emboli and thrombi from vessels of the peripheral venous system.
Contraindications
Not for use in the vessels of the cardiac, pulmonary, coronary and neurovasculature.
Warnings
The Aspirex™ Thrombectomy Catheters may only be used in conjunction with the Drive System and the provided Aspirex™ Guidewire of appropriate size. The Aspirex™ Thrombectomy Catheters are supplied sterile and are intended for single use only. Do not resterilize or reuse the device. Failure to ensure sufficient blood flow to the catheter head could result in drawing of the vessel wall into a side window(s). Failure to ensure sufficient blood flow through the catheter head could result in damage to the catheter due to overheating. Do not operate the Aspirex™ Thrombectomy Catheter near fractured areas of broken stents or stent grafts. Do not use the Aspirex™ Thrombectomy Catheter or Aspirex™ Guidewire if kinked or through a kinked or damaged introducer sheath. The safety and efficacy of this device has not been established in vessels with a radius of curvature < 2 cm. It is recommended to select the largest catheter diameter in order to reduce the potential for embolism. The catheter size should be selected based on the minimum vessel diameter. The risk of embolism increases with the difference in diameter between the native vessel and the minimum vessel diameter.
Precautions
The Aspirex™ Thrombectomy System should only be used under adequate visual monitoring with suitable radiographic techniques. The Aspirex™ Thrombectomy System does not contain any parts that can be maintained or serviced by the end-user. Do not repair or change the configuration of the product. The Aspirex™ Thrombectomy Catheters must not operate dry and must be primed and flushed using heparinized saline before and during use per the Directions for Use. The Aspirex™ Thrombectomy Catheters must not operate without an Aspirex™ Guidewire. Do not use the Aspirex™ Thrombectomy Catheter Set when product damage is evident, if packaging is damaged, or if the sterilization expiration date has passed. Ensure the Aspirex™ Thrombectomy Catheter is manipulated slowly with a back-and-forth motion as described in the Directions for Use. Insufficient blood flow through the catheter may result in intra-catheter clot formation, slow or absent therapeutic function, fracture of the helix and/or guidewire, and/or overheating of the catheter. The device is intended for use by physicians who have received appropriate training.
Potential Adverse Events
Potential adverse events include, but are not limited to: Acute occlusion; Air embolism; Allergic/anaphylactic reactions; Amputation; Arteriovenous fistula, pseudo-aneurysm; Atrial Fibrillation; Death; Detachment of catheter or guidewire; Device malfunction; Distal embolization; Emboli; Emergent surgery; Entrapment; Excessive blood loss; Hematoma, hemorrhage; Hypotension; Inability to completely remove thrombus; Intimal disruption; Ischemia; Kidney damage from contrast media; Myocardial infarction; Respiratory failure; Sepsis/Infection; Thrombophlebitis; Thromboembolic events; Vessel spasm, thrombosis, dissection or perforation, or valve damage.