Biocompatibles, Inc.

Biocompatibles, Inc. Drugs

• Varithena
  

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  Varithena

  

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  For intravenous use only.

  Varithena™ is intended for intravenous injection using ultrasound guidance, administered via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities. Use up to 5 mL per injection and no more than 15 mL per session.

  Physicians administering Varithena™ must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease, and be trained in the administration of Varithena™.

  Activate Varithena™ using the Varithena™ oxygen canister and polidocanol canister (see Instructions for Use). Once a Varithena™ transfer unit is in place, foam can be generated and transferred to a syringe. Discard the syringe contents if there are any visible bubbles. Administer the injectable foam within 75 seconds of extraction from the canister to maintain injectable foam properties. Use a new sterile syringe after each injection. Use a new Varithena™ transfer unit for each treatment session.

  Local anesthetic may be administered prior to cannula insertion but neither tumescent anesthesia nor patient sedation is required. Cannulate the vein to be treated using ultrasound guidance to confirm venous access.

  Inject freshly generated Varithena™ injectable foam slowly (approximately 1 mL/second in the GSV and 0.5 mL/second in accessory veins or varicosities) while monitoring using ultrasound. Confirm venospasm of the treated vein using ultrasound.

  When treating the proximal GSV, stop the injection when Varithena™ is 3-5 cm distal to the saphenofemoral junction (SFJ).

  Apply compression bandaging and stockings and have the patient walk for at least 10 minutes, while being monitored. Maintain compression for 2 weeks after treatment.

  Repeat treatment may be necessary if the size and extent of the veins to be treated require more than 15 mL of Varithena™. Separate treatment sessions by a minimum of 5 days.

  Retained coagulum may be removed by aspiration (microthrombectomy) to improve comfort and reduce skin staining.

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