MYNX CADENCE and MYNXGRIP VASCULAR CLOSURE DEVICE

INDICATIONS FOR USE

Mynx, Mynx Cadence and MynxGrip are indicated for use to seal femoral arterial access sites while reduc¬ing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath.

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CONTRAINDICATIONS

There are no known contraindications for Mynx, Mynx Cadence or MynxGrip.

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WARNINGS

Do not use if the sterilization indicator dot on the pouch is yellow/gold.

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, Mynx Cadence and MyxGrip are 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, Mynx Cadence or MynxGrip 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, Mynx Cadence or MynxGrip if the puncture is through the posterior wall or if there are multiple punctures, as such punctures may result in a retroperitoneal hematoma/bleed.

PRECAUTIONS

Mynx, Mynx Cadence and MynxGrip should only be used by a trained licensed physician or healthcare professional.

Mynx, Mynx Cadence and MynxGrip should not be used in patients with a known allergy to PEG.

Ordering Information

The MynxGrip™ Vascular Closure Devices include:
(1) Balloon catheter with integrated sealant
(1) 10 ml locking syringe

The Mynx Cadence™ Vascular Closure Device includes:
(1) Balloon catheter with integrated sealant
(1) 10 ml locking syringe

The Mynx™ Vascular Closure Devices include:
(1) Balloon catheter with integrated sealant
(1) 10 ml locking syringe

The Bengal™ Band includes:
(1) Compression bracelet
(1) Adaptor
(1) Sterile gauze pad

In the United States, fax your order to AccessClosure at (877) 933-0133 or email to customerservice@accessclosure.com

Outside of the United States, contact your local Mynx distributor