Important Safety Information
The following statements are associated with the regulatory approvals of the VENCLOSE™ procedure.
Indications for Use
The VENCLOSE™ RF Ablation Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
The VENCLOSE RF Ablation Catheter is contraindicated in patients with thrombus in the vein segment to be treated.
Potential Adverse Events
Potential adverse events include, but are not limited to, the following: vessel perforation, skin discoloration, nerve injury, temporary paresthesia, thrombosis, deep vein thrombosis, phlebitis, hematoma, infection, skin burn, pulmonary embolism, pain.