MYNX CONTROL™ Vascular Closure Device

Documentation

• MYNX CONTROL™ CONTROL Brochure
• MYNX CONTROL™ CONTROL Step-by-Step Guide
• MYNX CONTROL™ CONTROL Instructions for Use
• MYNX® Family: Patient Discharge Sheet - English
• MYNX® Family: Patient Discharge Sheet - Spanish

Clinical Articles

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 CONTROL™ Vascular Closure Device
The Baptist Memorial Hospital experience revisited.
David Wolford, MD, FACC. Endovascular Today. August 2010.

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, email us your order at GMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com or call us at 800.327.7714. Outside of the United States, contact your local MYNX™ device distributor.

The MYNX CONTROL™ VCD includes:

• (1) MYNX CONTROL™ VCD including balloon catheter and integrated polyethylene glycol sealant
• (1) 10 ml locking syringe 

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.

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.

See IFU for complete information.