INDICATIONS FOR USE:
MYNX CONTROL™ VCD is indicated for use to seal femoral arterial access sites while reducing times to hemostasis and
ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F, or 7F procedural sheath.
MYNX CONTROL™ VCD should only be used by a trained licensed physician or healthcare professional. MYNX CONTROL™ VCD should
not be used in patients with a known allergy to PEG. MYNX CONTROL™ VCD should not be used with sheaths longer than 12 cm effective length or
incompatible sheaths listed in Table 9 of the Instructions for Use.
Do not use if components or packaging appear to be damaged or defective or if any portion of the packaging has been previously
opened. DO NOT REUSE OR RESTERILIZE. MYNX CONTROL™ VCD is for single use only. The catheter is loaded with a single hydrogel sealant. Reuse
of the device would result in no delivery of hydrogel sealant. Do not use MYNX CONTROL™ VCD if the puncture site is located above the most inferior
border of the inferior epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in
a retroperitoneal hematoma/bleed. Perform a femoral angiogram to verify the location of the puncture site. Do not use MYNX CONTROL™ VCD if the
puncture is through the posterior wall or if there are multiple punctures, as such punctures may result in a retroperitoneal hematoma/bleed.
Federal (US) law restricts this device to sale by or on the order of a physician.
Prior to use, refer to the Instructions for Use supplied with this device for indications, contraindications, side effects,
suggested procedure, warnings, and precautions.
See IFU for complete information.