The MynxGrip Vascular Closure Device (MynxGrip) is designed to achieve femoral artery and femoral vein hemostasis via delivery of an extravascular, water-soluble synthetic sealant using a balloon catheter in conjunction with a standard procedural sheath. The sealant is made of a polyethylene glycol (PEG) material which expands upon contact with subcutaneous fluids to seal the arteriotomy or venotomy. The sealant is resorbed by the body within 30 days. MynxGrip is supplied with a 10 ml locking syringe used for balloon inflation and deflation. There are no components manufactured from latex rubber. The MynxGrip 5F device has a gray shuttle. The MynxGrip 6F/7F device has a green shuttle.

INDICATIONS FOR USE

MynxGrip is indicated for use to seal femoral arterial and femoral venous 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. 

The MYNXGRIP® device is indicated for use to seal femoral arterial and femoral venous 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

• The MYNXGRIP® device should only be used by a trained licensed physician or healthcare professional.
• The MYNXGRIP® device should not be used in patients with a known allergy to PEG. 

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.
• The MYNXGRIP® device is for single use only.
• The balloon catheter is loaded with a single hydrogel sealant.
• Reuse of the device would result in no delivery of hydrogel sealant.
• Do not use the MYNXGRIP® device if the puncture site is located above the most inferior border of the inferior epigastric artery (IEA) (for arterial application) and/or above the inguinal ligament based upon osseus landmarks, since such a puncture site may result in a retroperitoneal hematoma/bleed.
• Perform a femoral angiogram or venogram to verify the location of the puncture site.
• Do not use the MYNXGRIP® device 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 Vascular Closure Device (Mynx) was evaluated in a prospective multicenter, 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 Trial and the standard compression arm of the MATRIX Trial. Clinical data collected on the Mynx device is directly applicable to the MynxGrip.