MYNXGRIP? Vascular Closure Device

Documentation

• MYNXGRIP^? overview brochure
• MYNXGRIP^? procedure guide
• MYNXGRIP^? instructions for use
• MYNXGRIP^? procedure poster
• MYNXGRIP^? patient brochure
• MYNX^? Family: Patient Discharge Sheet - English
• MYNX^? Family: Patient Discharge Sheet - Spanish

Clinical articles

Mynx Vascular Closure Device Achieves Reliable Closure and Hemostasis of Percutaneous Transfemoral Venous Access in a Porcine Vascular Model
S. Sanjay Srivatsa, MBBChir1; Arjun Srivatsa1; Taylor A. Spangler, DVM, DACVP2. The Journal of Invasive Cardiology. February 2015

The MYNXGRIP? Vascular Closure Device
Hoang Minh Thai, MD, FACC, FSCAI, and Barry S. Weinstock, MD. Endovascular Today. April 2012.

Successful Reduction of Surgeries Secondary to Arterial Access Site Complications
A Retrospective Review at a Single-Center with an Extravascular Closure Device.
Noor S, Meyers S, Curl R. Vascular and Endovascular Surgery. May 2010;44(5):345-9.

A Prospective Randomized Single-blind trial of Patient Comfort Following Vessel Closure
Extravascular Synthetic Sealant Closure Provides Less Pain than a Self-tightening Suture Vascular Compression Device.
Fargen KM, Hoh BL, Mocco J. J Neurointerv Surg. 2011;3(3):219-23

Mynx Vascular Closure Device Early Ambulation Study
Vikranth R. Gongidi, DO; Ahsan Jafir, DO; and Vijay Verma, MD, FACC, FSCAI. Endovascular Today. October 2013

Occurrence of angiographic femoral artery complications after vascular closure with Mynx and AngioSeal
Fargen KM, Velat GJ, Lawson MF, et al. Journal of Neurolnterventional Surgery. 2013;5(2):161-4

Use of Vascular Closure Device After Access of Common Femoral Artery Through an Existing Stent
George JC. Vascular Disease Management. 2012;9(5):E68-E70.

Two Years of Extravascular Closure With the Mynx? Vascular Closure Device
The Baptist Memorial Hospital experience revisited.
David Wolford, MD, FACC. Endovascular Today. August 2010.

Mynx Closure in a Patient Treated for Chronic Total Occlusion of the Iliac Artery with Multiple Sheath Exchanges.
A Case Review. Michael S. Fenster, MD. TCTMD. May 2009.

Why Extravascular Closure?
The Baptist Memorial Hospital Experience with the Mynx Vascular Closure Device
David Wolford, MD, FACC. Endovascular Today. August 2009.

The Safety and Efficacy of an Extravascular, Water-Soluble Sealant for Vascular Closure
Initial Clinical Results for Mynx. D. Scheinert MD et al. Catheterization and Cardiovascular Interventions. November 2007.

In the United States, fax your order to 877.933.0133, email?GMB-ACI-Customer-Service@cardinalhealth.com,?or call 877.700.6969. Outside of the United States, contact your local MYNX? device distributor.

The MYNXGRIP? Vascular Closure Device includes:

• Balloon catheter with integrated sealant
• 10 ml locking syringe?

Product	Size	Order Number
MYNXGRIP? Vascular Closure Device	5F	MX5021
MYNXGRIP? Vascular Closure Device	6F/7F	MX6721

Indications For Use: 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. Potential Adverse Events: In addition to the complications noted in the MYNX? device clinical trial, the following potential complications, which may be related to the endovascular procedure or the vascular closure, may occur: allergic reaction, ecchymosis, superficial vein thrombosis, foreign body/local reaction, retroperitoneal bleed, vessel occlusion, pulmonary embolism, or death. See IFU for complete information.