The innovative design and predictable deployment of MYNX CONTROL™ Vascular Closure Device delivers outstanding performance and control for consistently secure arterial closures.

• 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.

Precautions

• 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.

Warnings:

• 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.

The MYNX® VCD was evaluated in a prospective multi-center, non-randomized clinical trial involving 190 patients to achieve femoral arterial access site hemostasis following diagnostic angiography (n=95) or interventional procedures (n=95). The control arm (standard compression) from the MATRIX VSG™ System Clinical Trial (MATRIX) was used as a historical control group. Table 1 is a report of the total number and the rate of major and minor complications in the MYNX VCD Trial and the standard compression arm of the MATRIX Trial. Clinical data collected on the MYNX VCD is directly applicable to the MYNX CONTROL VCD.