CLOSES WITH SECURITY.

LEAVES WITHOUT A TRACE.*

*The sealant is resorbed by the body within 30 days.

 Close with Confidence. Leave Nothing Behind*.

MYNX CONTROL™ Vascular Closure Device features a redesigned, ergonomic handle to facilitate Secure Extravascular Closure
ease-of-use and predictable deployment. in a wide range of clinical scenarios
Clinically versatile, MYNX CONTROL™ VCD offers dependable closure with nothing left behind*
The Science of Active Extravascular Sealing —treats a wide range of patients and clinical scenarios.
MYNX™ GRIP TIP MYNX™ Sealant
MYNX CONTROL™ VCD is comprised of two
configurations of polyethylene glycol (PEG),
for durable hemostasis.

Proven PEG Material

• SAFE No foreign-body reaction or scar tissue formation1

• SYNTHETIC Non-thrombogenic1
• HYDROLYTIC DEGRADATION Fully resorbs through hydrolysis—no enzymatic breakdown1 Safe closure below the
femoral bifurcation†2

Dual-mode Active Sealing

MYNX™ SEALANT FULLY EXTRAVASCULAR
MYNX™ GRIP TIP
COLUMN CLOSURE
Useful on antegrade
punctures3

=
Sealant
MYNX™
GRIP TIP
Arteriotomy

No footplates,
• Activated by body • Expands to 3-4 times its sutures, or metal

30
temperature and pH original size on contact with implants to
blood and subcutaneous impede reaccess
• Interlocks with
fluids, creating a matrix
contours of the vessel
structure for clot formation
by actively attaching
to the artery, for secure • Provides further support DAY
RESORBABILITY* Balloon visualization
mechanical closure for the MYNX™ GRIP TIP
verifies position

*The sealant is resorbed by the body within 30 days. †Confirm vessel size is ≥ 5mm
 Safety by the Numbers.

MYNX™ VCD has been clinically proven to reduce surgical complications, expedite recovery, Reduced Risk and Severity of Complications
shorten hospital stays, and increase patient comfort.2-7‡
In a retrospective, single-center review of 11,006 cardiac and peripheral vascular procedures,
MYNX™ VCD was proven to reduce the risk and severity of surgical complications following
Safety and Efficacy in Interventions catheterization, compared to Angio-Seal™ and manual compression.6
A single-center, multi-year comparative analysis involving 4,074 percutaneous coronary intervention
(PCI) patients found MYNX™ VCD to be equally safe and effective as Angio-Seal™, with no intra-arterial Rate of surgical repair 6
components left behind.4 0.7 p<0.0001

Access-site bleeding and vascular injury4 0.6 0.61% • 10x fewer secondary surgeries than Angio-Seal™6
• 3x fewer secondary surgeries than manual

Incidence Rate (%)

3.0 0.5
compression6
0.4
p-value=0.6
• MYNX™ VCD complications did not involve
2.3%
Incidence Rate (%)

0.3 p=0.14
embolism or artery damage, worsening of
0.2 0.19% peripheral vascular disease, or necessitate
2.0 device removal6
0.1 0.06%
1.5% 0.0
Angio-Seal™ MYNX™ VCD Manual
Compression
1.0
MYNX™ VCD Angio-Seal™

Increased Patient Comfort

Safety in Clinical Trials and Real-world Use
In a prospective multi-center, non-randomized clinical trial (n=190) MYNX™ VCD demonstrated: 2,8 In a blinded, randomized clinical study, pain at closure and pain increase from baseline to close were
significantly lower for MYNX™ VCD than Angio-Seal™.7

99.5% Procedure success rate Less pain than Angio-Seal™

10
Worst Pain

Mean Pain (Visual Analog Scale)

8
p=0.0009
1.3 MIN Time to hemostasis 6
5.03
Angio-Seal™
4
2.94
In a real-world cohort of 432 patients undergoing coronary angiography, MYNX™ VCD demonstrated: 5 MYNX™
NEARLY 2
Faster time to ambulation1
3X ( 2.6 hours vs. 7.4 hours with standard compression )
0 Least Pain
99.5% Same-day discharge Pre-closure Closure

0.5 % Rate of major complications 1

‡Time to discharge eligibility as compared to manual compression. MATRIX Clinical Trial (IDE# G030182). Data on file.
 Procedure Steps

Made for Predictable Deployment. 1. DEPLOY THE BALLOON

Designed for Ease of Use.

The next-generation MYNX CONTROL™ Vascular Closure Device (VCD) deployment

system is purpose-designed to enhance safety and deliver reliable performance.

Achieve temporary hemostasis and position at

Tension Indicator Ergonomic Handle the arteriotomy.

Provides visual Facilitates ease of 2. PLACE THE SEALANT

confirmation of device use for predictable

position for proper deployment
sealant deployment

The MYNX™ GRIP TIP securely adheres to the artery

and MYNX™ Sealant fills the tissue tract.

3. REMOVE THE DEVICE

Sheath Catch Button #1 Button #2

Compatible with Deploys and One-step balloon Platelets and blood cells collect inside the sealant’s
porous matrix.
procedural sheath— compresses withdrawal
eliminates the need the sealant
4. FINAL RESULT
for sheath exchanges§

The sealant dissolves within 30 days

§MYNX CONTROL™ VCD is incompatible with Medtronic Input® Introducer (11cm) sheaths, Cook Check-Flo®
leaving nothing behind but a healed artery.
Performer® Introducer sheaths, and procedural sheaths longer than 12cm in effective length.
 Closes with Security. Leaves Without a Trace.*
MYNX CONTROL™ Vascular Closure Device (VCD) integrates dual-mode active sealing and
resorbability with a next-generation delivery system to maximize predictability, safety,
and ease of use.

SECURE SAFET Y AND E A SE OF

CLOSURE PAT I E N T C O M F O R T USE

*The sealant is resorbed by the body within 30 days.

Ordering Information
The MYNX CONTROL™ VCD includes:
(1) MYNX CONTROL™ VCD including balloon catheter and integrated polyethylene glycol sealant
(1) 10ml locking syringe

SIZE EMEA ORDER NUMBER

5F MX5060E
6F/7F MX6760E

To order the MYNX CONTROL™ VCD contact your local Cordis sales representative or customer
service. Visit cardinalhealth.co.uk to learn more.

REFERENCES: 1. Scheinert D, Sievert H, Turco MA, et al. The safety and efficacy of an extravascular, water-soluble sealant for vascular closure: Initial
clinical results for MYNX™. Cathet Cardiovasc Intervent. 2007 Oct;70:627-633. 2. MYNX CONTROL™ Vascular Closure Device Instructions for Use. 3. Pruski
MJ Jr, Blachut AM, Konkolewska M, et al. MYNX™ GRIP for closure of antegrade puncture after peripheral interventions with same-day discharge. Vasc
Endovasc Surg. 2017 Feb;51(2):67-71. 4. Baker NC, Escarcega RO, Lipinski MJ, et al. Active versus passive anchoring vascular closure devices following
percutaneous coronary intervention: a safety and efficacy comparative analysis. J Interv Cardiol. 2016 Feb; 29(1): 108-112. 5. Hutchings D, Hayat A,
Karunakaran A, Malik N. Success, Safety, and Efficacy of the MYNX™ Femoral Closure Device in a Real-World Cohort: Single-Center Experience. J
Invasive Cardiol. 2016 Mar;28(3): 104-108. 6. Noor S, Meyers S, Curl R. Successful reduction of surgeries secondary to arterial access site complications: a
retrospective review at a single center with an extravascular closure device. Vasc Endovascular Surg. 2010 Jul;44(5):345-349. 7. Fargen KM, Hoh BL, Mocco
J. 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. J NeuroInterv Surg. 2011 Sep; 3(3): 219-223. 8. MATRIX Clinical Trial (IDE# G030182). Data on file.
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 12cm effective length or
incompatible sheaths listed in Table 1 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.

For Healthcare Professionals Only. Important information: Prior to use, refer to the Instructions for Use supplied with this device for indications,
contraindications, side effects, suggested procedure, warnings and precautions. As part of its continuous product development policy, Cordis reserves
the right to change product specifications without prior notification. CORDIS, the Cordis LOGO and MYNX CONTROL are trademarks of Cardinal
Health and may be registered in the US and/or in other countries. © 2019 Cardinal Health. All Rights Reserved. 100538826 06/2019