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Product Support

The resources provided are for informational purposes only and are not intended to take the place of product labeling. Refer to the Instructions for Use (IFU) supplied with each product for specific information on indications for use, contraindications, warnings and precautions.

Instructions for Use (IFU)

Catalog Number AC3930A is commercially available only in the U.S.

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Key Stats

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Sales Brochure

View Angel® Catheter Sales Brochure

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Clinical Evidence

View Angel® Catheter Clinical Evidence Packet

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Procedural Steps Overview

View the procedural steps overview for the Angel® Catheter

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Procedural Steps Checklist

View the procedural steps checklist for the Angel® Catheter

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Notification Placard

View the notification placard for the Angel® Catheter

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Placement Accessories and Recommendations

View placement accessories and recommendations for the Angel® Catheter

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Product Data Sheet

View Angel® Catheter Product Data Sheet

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Terms & Conditions

View our Terms & Conditions.

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Frequently Asked Questions

Arrow IconDo Femoral Central Venous Catheters (CVCs) have a higher risk of infection than CVCs inserted via other access sites?

Recent studies show that there is little difference in infection rates between access sites since the implementation of maximal barrier precautions (Matching Michigan, CDC Bundles of Care, etc.) when inserting CVCs. Additionally, infection was closely studied throughout both the Angel® Catheter Pivotal Study as well as the European Post Market Registry Study. During the Angel® Catheter Pivotal Study there were 0 incidences of catheter related bloodstream infection (CRBSI) in 1108 catheter days. And there were 0 incidences of CRBSI in 381 catheter days during the Registry Study.

Arrow IconDoes the presence of the Angel® Catheter predispose a patient to the risk of catheter related thrombosis due to placement via the femoral vein?

Any type of vascular access device as well as all Inferior Vena Cava (IVC) filters and Central Venous Catheters (CVCs) can increase the risk of developing thrombus. However, the Angel® Catheter is intended for short-term dwell times which reduce the risk significantly. DVT or caval occlusion associated with traditional IVC filters are a late stage complication and not typically seen in the first couple of weeks of implantation. Additionally, risk of catheter related thrombosis was closely studied throughout the Angel® Catheter Pivotal Study. The study confirmed an incidence of venous thromboembolic events in critically ill trauma subjects with an 11.04% baseline rate of acute lower extremity DVT, and 18.40% of subjects developing a new acute proximal lower extremity DVT an average of 11 days after the admission to the critical care unit.

The reported rate of thrombotic events is similar to the landmark studies by Geerts et al., evaluating the rates of venous thromboembolism (18.1%) after trauma with the use of prophylactic anticoagulation in trauma subjects that could be anticoagulated. The 12.27% rate of catheter related thrombosis (CRT) reported in the Angel® Catheter Pivotal study is consistent with the rates of femoral catheter related thrombosis reported in multiple other clinical studies. A systematic review reported 154 (12.9%) catheter related thromboses in 1189 patients with a femoral central venous catheter. The risk of PEs secondary to CRT is generally felt to be lower than the associated spontaneous DVTs in high risk populations.

Arrow IconIs the Angel® Catheter prone to the complications associated with other IVC filters?

The unique design and short-term dwell time of the Angel® Catheter reduces the risk of complications that are commonly associated with traditional IVC filters (i.e., fracture, perforation, migration, and filter deployment issues).

Arrow IconWhat should occur if there is clot in the femoral vein (or both femoral veins) at the time of placement? Will a PE be dislodged by using the Angel Catheter?

If there is thrombus in one of the femoral veins, simply place the Angel® Catheter in the contra-lateral leg. This patient would greatly benefit from the protection provided by the Angel® Catheter as patient is at high risk for PE and may need immediate protection. If patient has bilateral femoral thrombus, we recommend sending the patient to Interventional radiology (IR) for jugular placement of a traditional Inferior Vena Cava filter. Patient may be hyper-coagulable and need long term protection while the bilateral thrombus is treated.

Arrow IconWhat should I do when there is a significant thrombus observed at the time of the pre-removal cavogram?

Per the IFU, “Do NOT retrieve filter if significant amount of thrombus (greater than 25% of the volume of the filter) is observed without attempting to mitigate with clinically acceptable means.” Clinically acceptable means of clot mitigation might include a tPA infusion and/or anticoagulation for at least 24 hours. When possible, consider postponing Angel® Catheter removal until there is a resolution or significant reduction of thrombus. Otherwise, another option would be to place a traditional temporary or permanent vena cava filter before removal.

In the Angel® Catheter Pivotal Study, an IVC filter was inserted in 6 of the 14 subjects with an averted PE, defined as thrombus >25% of the volume of the filter. Anticoagulation was started on the day of removal in 1/14 (7.14%) subject, 2/14 (14.29%) subjects did not receive anticoagulation at any time during the study period, and the remaining 11/14 (78.57%) subjects received anticoagulation an average of 3.50±3.78 days (median of 2; range of 0-14 days) prior to the removal. Only 1 subject (7.14%) received thrombolytics approximately 3 days after catheter removal.

If the clot does not qualify as a significant thrombus greater than 25% of the volume of the filter, it may be safe to remove the device without further action to mitigate the clot. Use clinical discretion, taking into consideration the patient’s condition, specifically whether the patient is hemodynamically unstable.

Arrow IconAre there any device-specific tips or advice that I should be aware of?

Yes. To protect against inadvertent removal of the Angel® Catheter, ensure that the teal/blue and white catheter hubs are securely locked together immediately following device insertion. The suture wing and suture wing overclamp should be positioned and sutured close to the access site though it is recommended that space be allowed for proper positioning of a BIOPATCH®, or alternative anti-infective dressing around the access site. This will also aid in preventing wicking of fluids into the overclamp. It is also recommended to place sutures through the loops of the catheter hub to reduce the possibility of inadvertent decoupling of the catheter hub.

The Angel® Catheter typically does not end up inserted all the way to the hub and often will have more catheter exposed than may be common with other CVCs. During the Angel® Catheter Pivotal Study, the staff was trained to cover as much of the catheter as possible while still allowing access to the ports. Coban™ self-adherent wrap may be used to cover the exposed catheter; other suggestions are kling/kerlix/ace bandages. The goal is to limit the patient’s ability to grasp the device than to secure it tightly. For placement in the right femoral vein, 27cm is a good starting point for insertion. For placement in the left femoral vein, 29 cm is a good starting point. This applies to most patients within a normal height range (around 5 – 6’2).

Arrow IconDoes the Angel® Catheter have to be utilized as a CVC?

No, but all catheter ports should be either vigorously flushed every 8-12 hours or have a continuous infusion to Keep Vein Open (KVO).

Arrow IconWhat should be done if it is noticed that the Angel® Catheter moves when the patient moves?

Some catheter movement may occur/be observed and should not cause any complications. Patients should continue to be assessed daily. If there are any indications of adverse events, these events should be investigated and recorded.

Arrow IconWhat actions are required if a pre-retrieval lower extremities Doppler results in the diagnosis of a significant DVT?

There are multiple options including starting anticoagulation and/or thrombolytics, and postponing the retrieval of the device until the clot has resolved or significantly reduced in size. However, if the device needs to be removed immediately after the diagnosis and the patient is still at high risk of PE and/or has contraindications to anticoagulation, an IVC filter should be placed. Do not retrieve filter without attempting to mitigate with clinically acceptable means.

Arrow IconIf patient is on Plavix are they a candidate for the Angel® Catheter?

Yes, aspirin and Plavix are not considered to be anticoagulants and they are not associated with increased complications with the use of the device. Also, they do not have a preventative role for DVTs or PE as their effect is mostly on platelets and not in the prevention of venous clots.

Arrow IconCan rapid infusers or pressure bags be used with the Angel® Catheter?

Yes. See table below for gravimetric and power injection flow rates. Do not exceed maximum injection pressure of 300psi. When using rapid infusers and pressure bags, equipment pressure limits may limit maximum obtainable flow rates for fluids. Defer to institutional and equipment manufacturer guidelines for minimum/maximum flow rates for using rapid infusers and pressure bags.

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Arrow IconDoes the Angel® Catheter have an antimicrobial coating?

The Angel® Catheter has a hydrophilic coating to aid in insertion but does not have an antimicrobial coating.

Arrow IconIf patient has already had a femoral line CVC and it’s removed, can the Angel® Catheter be placed on that side at ANY time following the removal of the initial CVC?

Yes, however, it is recommend that the Angel® Catheter not be placed via an exchange over a guidewire from a pre-existing CVC due to the potential risk of infection.