MYNX ACE® Vascular Closure Device

Documentation

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

Clinical articles

The MYNX ACE® Vascular Closure Device
Rajesh M. Dave, MD. Endovascular Today. February 2015

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. Vasc Endovascular Surg. 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. J Neurointerv Surg. 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. May 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. October 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 MYNX ACE® Vascular Closure Device includes:

• (1) MYNX ACE^® Device including balloon catheter and integrated sealant
• (1) 10 ml locking syringe
• (1) Introducer
• (1) Dilator

Product	Size	Order Number
MYNX ACE® Vascular Closure Device	5F/6F/7F	MX6740

Indications for Use: The MYNX ACE® device 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: The MYNX ACE® device should only be used by a trained licensed physician or healthcare professional. The MYNX ACE® 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 MYNX ACE® device 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 the MYNX ACE® device 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 the MYNX ACE® 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: See IFU for a list of Potential Adverse Events.