HeRO Vascular Access Device

HeRO is a fully subcutaneous AV access solution, clinically proven to maintain long-term access for hemodialysis patients with venous outflow obstruction.

Like other specialized ePTFE grafts, HeRO may require periodic maintenance. A percutaneous technique is recommended (e.g. a rheolytic thrombectomy system, balloon maceration, or balloon assisted aspiration.)

Use of fluoroscopy during any HeRO intervention is strongly recommended.

Restoring HeRO Patency:

• INTRODUCE a 7F short vascular sheath near the arterial anastomosis.
• INFLATE a soft, compliant, embolectomy balloon at the radiopaque marker band of the 5mm Venous Outflow Component. DO NOT advance the balloon beyond the radiopaque marker band to avoid dislodgement of the Venous Outflow Component.
• PULL balloon back to device connector. Apply positive aspiration while deflating the balloon by approximately 10%. Failure to deflate the balloon may result in balloon perforation as the catheter passes through the HeRO titanium connector.
• PULL balloon through the connector and reinflate within the 6mm graft.
• EXTRACT clot at the introducer site.
• DECLOT the full length of HeRO device prior to removing the arterial plug to decrease risk of pulmonary embolism.

Arterial Plug Removal

• CHOOSE a Fogarty embolectomy balloon sized for the artery (3-4mm) and insert past the arterial plug.
• INFLATE the balloon, "pop" the arterial plug, then pull back to the introducer site.
• EXTRACT the arterial plug, then confirm flow and patency throughout the device. Ultrasound may be used to assess flow.
• RECONFIRM placement of the device connector and Venous Outflow Component tip via fluoroscopy.

Tips for Successful Outcomes

• Percutaneous or surgical technique may be used to declot HeRO. A surgical technique is recommended during the graft incorporation period to avoid risk of seroma or other complications.
• A 90cm thrombectomy tool is required to accommodate the entire length of the HeRO device.
• Administration of drugs such as TPA or urokinase to lyse the thrombus is recommended.
• Thrombus may be soft or gelatinous in nature and is likely to be present throughout the entire device.
• Mechanical/rotational devices (e.g., Trerotola® device) are contraindicated as internal damage to the Venous Outflow Component and connector may occur.

Patency Data

HeRO patency was evaluated in a prospective, randomized study and found to be equivalent to standard ePTFE grafts. Additionally, the HeRO intervention rate of 2.5 per year can be considered equivalent to an ePTFE graft literature control of 1.6 – 2.4 average interventions per year. As a specialty ePTFE graft, HeRO will require the same frequency of intervention and declot maintenance as any standard ePTFE graft. (See Clinical Outcomes Comparison for more information.)

Troubleshooting Thrombosis

• Test for coagulability disorders after repeated clotting episodes.
• After a clotting episode, thoroughly image the inflow artery all the way to the shoulder and throughout the entire HeRO device, including the outflow component tip, to identify root causes.
• Consider prescribing an anticoagulant in patients with repeated clotting episodes.
• During dialysis treatment, closely monitor the patient for hypotensive events.
• Avoid using fistula clamps after a dialysis session.

Contact Hemosphere Customer Service at 888.313.8233 with device-related or technical questions and tell us about your experience by sending us an email at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

Thrombectomy
Guidelines

INTENDED USE

The HeRO Vascular Access Device is intended for use in maintaining long-term vascular access for chronic hemodialysis patients who have exhausted peripheral venous access sites suitable for fistulas or grafts. See the Instructions for Use manual for full prescribing information.

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