Cordis MX61260 Mynx Control Venous Vascular Closure Device

SYMBOLS

Explanation of symbols on labels and packaging:

	CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
	Do not re-use
	Use-by date
	Lot number
	Sterilized using irradiation
	Consult instructions for use or consult electronic instructions for use
	Keep dry
	Do not use if package is damaged and consult instructions for use
	Upper limit of temperature
	Catalogue number
	Manufacturer
	n units per box
	Prohibition
	Wait for two minutes
	Do not re-sterilize
	Caution
	Keep away from sunlight
	Non-Pyrogenic
	10 ml LOCKING SYRINGE
	Medical Device
	Single sterile barrier system; Sterilized using irradiation

STERILE. Sterilized with electron beam radiation. Nonpyrogenic. For one use only. Do not re-sterilize. Store in a cool, dark, dry place.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

INSTRUCTION FOR USE

The device brand name is the Cordis MYNX CONTROL™ VENOUS Vascular Closure Device (VCD) 6F-12F To ensure proper deployment and use of this device and to prevent injury to patients, read all information contained in these instructions for use.

DEVICE DESCRIPTION

The MYNX CONTROL VENOUS VCD 6F-12F is designed to achieve femoral vein hemostasis via delivery of the GRIP TECHNOLOGY™ sealant, an extravascular, water-soluble synthetic hydrogel, using a balloon catheter in conjunction with a standard procedural sheath. The GRIP TECHNOLOGY™ sealant is made of a polyethylene glycol (PEG) material which expands upon contact with subcutaneous fluids to seal the venotomy. The sealant is resorbed by the body within 30 days.
The MYNX CONTROL VENOUS VCD 6F-12F sheath catch is designed to accommodate large Catheter Sheath Introducers up to 12F inner diameter.
The MYNX CONTROL VENOUS VCD 6F-12F is supplied with a 10 ml locking syringe used for balloon inflation and deflation.
The device contains no components manufactured from latex rubber. The catheter shaft has a silicone lubricant to facilitate insertion and withdrawal into compatible sheaths.
Refer to Figure 1 for the MYNX CONTROL VENOUS VCD 6F-12F components.

INTENDED PURPOSE

The MYNX CONTROL VENOUS VCD 6F-12F is intended to achieve femoral vein hemostasis.

INDICATIONS FOR USE

The MYNX CONTROL VENOUS Vascular Closure Device (VCD) 6F-12F is indicated for use to seal femoral venous access sites while reducing times to hemostasis, ambulation, and discharge eligibillityin patients who have undergone catheterbased procedures utilizing 6F to 12F inner diameter procedural sheaths, with single or multiple access sites in one or both limbs.

PATIENT TARGET GROUP

The patient target group includes individuals who have undergone catheter-based procedures utilizing 6F to 12F inner diameter procedural sheaths, with single or multiple access sites in one or both limbs. The patient target group of this device is based on the patient’s anatomy and compatibility with the device.

PERFORMANCE CHARACTERISTICS

The MYNX CONTROL VENOUS VCD 6F-12F is designed to achieve femoral vein hemostasis via delivery of an extravascular, water-soluble synthetic sealant using a balloon catheter in conjunction with a standard procedural sheath. The balloon catheter is designed to be introduced into the femoral introducer sheath and provide temporary hemostasis. The hydrogel sealant is housed next to the balloon and delivered in the extravascular space above the venotomy via actuation of a Button in the delivery system when an appropriate tension is applied on the balloon to achieve temporary hemostasis. Upon delivery, the hydrogel sealant expands by absorption of the body fluids to achieve hemostasis.

CONTRAINDICATIONS

There are no known contraindications for the MYNX CONTROL VENOUS VCD 6F-12F.

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 CONTROL VENOUS VCD 6F-12F 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. Reuse of this product, including after reprocessing and/or re-sterilization, may cause a loss of structural integrity which could lead to a failure of the device to perform as intended and may lead to a loss of critical labeling/use information all of which present a potential risk to patient safety.
Do not use the MYNX CONTROL VENOUS VCD 6F-12F if the puncture site is located above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a hematoma/bleed. Verify the location of the puncture site via imaging.
Do not use the MYNX CONTROL VENOUS VCD 6F-12F if the puncture is through the posterior wall as such punctures may result in a retroperitoneal hematoma/bleed.

SHEATH INTRODUCERS INCOMPATIBLE WITH MYNX CONTROL VENOUS VCD 6F-12F
USE ONLY WITH A STANDARD SHEATH INTRODUCER with up to 12 cm effective length. Cordis test results have shown
that the sheath introducer listed in Table 1 is incompatible with the MYNX CONTROL VENOUS VCD 6F-12F due the hemostatic valve design

Table 1: Incompatible sheath introducer for all French sizes specific to the MYNX CONTROL VENOUS VCD 6F-12F range. The third-party trademarks used herein are trademarks of their respective owners.

The MYNX CONTROL VENOUS VCD 6F-12F should not be used if a < 6F or > 12F procedural sheath (inner diameter) is used at closure.

PRECAUTIONS

The MYNX CONTROL VENOUS VCD 6F-12F should only be used by a trained licensed physician or healthcare professional.
The MYNX CONTROL VENOUS VCD 6F-12F should not be used in patients with a known allergy to PEG.
The safety and effectiveness of the lubricated device has not been established, or is unknown, in vascular regions other than those specifically indicated. Do not expose lubricated catheter shaft to organic solvents or antiseptic solutions. Avoid wiping of the lubricated catheter shaft. In case of resistance with sheath introducer, exercise caution in removing the device and exchange device for a new one. Failure to abide by the warnings in this labeling might result in damage to the device lubrication, which may necessitate intervention or result in serious adverse events. Exposure to temperatures above 25°C (77°F) may damage the components.

SPECIAL PATIENT POPULATIONS

The safety and effectiveness of the MYNX CONTROL VENOUS VCD 6F-12F have not been established in the following patient populations:

• Pediatric patients or others with small common femoral veins (< 5 mm in diameter)
• Patients with clinically significant peripheral vascular disease in the vicinity of the puncture
• Patients with chronic use of systemic steroids
• Patients with prior surgical procedure, PTA, stent placement, or vascular graft in the common femoral vein
• Patients with bleeding disorders such as thrombocytopenia (platelet count <100,000/mm3), hemophilia, von Willebrand’s disease or anemia (Hgb < 10 g/dL, Hct < 30%)
• Patients with uncontrolled hypertension (systolic BP > 180 mm Hg)
• Patients with morbid obesity (BMI > 45 or < 20kg/m2,)
• Patients who are pregnant or lactating

POTENTIAL ADVERSE EVENTS

Complications may occur and may be related to the procedure or the vascular closure device. They include, but are not limited to:

• Allergic reaction
• Arterio-venous fistula
• Bleeding from the access site
• Bruising at the access site
• Death
• Deep vein thrombosis
• Device failure/malfunction
• Ecchymosis
• Edema
• Embolization (tissue, thrombus, air, calcific debris, device)
• Hematoma
• Infection
• Inflammatory reaction
• Intimal tear/dissection
• Laceration of the vessel wall
• Loss of lower extremity pulse
• Lower extremity ischemia
• Nerve injury
• Oozing from the access site
• Perforation of the vessel wall
• Pseudoaneurysm
• Pulmonary embolism
• Puncture site pain
• Retroperitoneal bleeding
• Superficial vein thrombosis
• Vascular injury
• Vascular occlusion
• Vasovagal response
• Venous thrombus
• Wound dehiscence

For the specific adverse events that occurred during the ReliaSeal Clinical Trial, please see ReliaSeal Clinical Trial Results.

RELIASEAL CLINICAL TRIAL

MYNX CONTROL VENOUS VCD 6F-12F was evaluated for safety and effectiveness in a prospective, multi-center, randomized (2:1) clinical trial comparing MYNX CONTROL VENOUS VCD 6F-12F to manual compression (MC) in sealing femoral venous access sites in patients who have undergone catheter-based procedures utilizing one or more procedural sheaths up to 12F with single or multiple access sites in one or both limbs. The study enrolled a total of 314 subjects (44 roll-in and 270 randomized) across 13 U.S. sites. The study endpoint objectives were to demonstrate MYNX CONTROL VENOUS VCD 6F-12F non-inferiority safety (combined major venous access site closure- related complications through 30 days post procedure) and effectiveness superiority (Time to Ambulation (TTA) in hours and Time to Hemostasis (TTH) in minutes) compared to MC. The hypothesis for the primary safety endpoint was that the rate of CEC-adjudicated combined major venous access site closure-related complications through 30 days post-procedure for subjects treated with the Mynx CONTROL VENOUS VCD is non-inferior to the rate for subjects using manual compression. Subjects were followed for 30 days after the procedure. Seventy-two (72) subjects (47 MYNX CONTROL VENOUS VCD and 25 MC) were enrolled in a duplex ultrasound (DUS) sub study. These subjects had a DUS prior to discharge and, if any complications were noted at discharge, those subjects were required to undergo a DUS at their 30-day follow-up visit. Patients were required to be 18 years of age, have signed the informed consent and have planned, elective, nonemergent catheter-based procedure(s) via the common femoral vein(s) using 6F – 12F introducer sheaths with no contraindications for emergent vascular surgery or manual compression of the venous access sites. Pregnant women or women who were lactating or planned to be pregnant were excluded. Patients were excluded if they used systemic steroids (IV or oral) within 30 days, had a history of bleeding disorders, deep vein thrombosis (DVT), pulmonary embolism (PE), or thrombophlebitis within 6 months, had a platelet count < 100,000 cells/mm3, hemoglobin (Hgb) < 10 g/dl, hematocrit (Hct) < 30%, uncontrolled hypertension (HTN) with systolic BP > 180 mm Hg, or critical illness requiring blood pressure (BP) stabilization, serum creatinine > 2.5 mg/dL, body-mass index (BMI > 45 kg/m2 or < 20 kg/m2, any allergy to polyethylene glycol or contrast medium, active systemic infection or cutaneous infection or inflammation at the target access site, Covid-19 infection, positive test within 14 days or recent Covid-19 exposure, life expectancy < 30 days, would refuse a blood transfusion if needed. Patients were also excluded if they had previous vascular surgery or repair in the vicinity of the target access site within 90 days, recent (within 10 days) femoral arteriotomy or venotomy in either limb, use of VCD in either limb within 30 days, planned procedures involving femoral arterial or venous access in either limb within 30 days post procedure or prior to study exit including planned staged procedures or concomitant conditions/comorbidities that per investigator’s judgement could extend ambulation attempts beyond 2-3 hours and/or require extended hospitalization or re-hospitalization, or were unable to walk at least 20 feet without assistance. Exclusion criteria evaluated prior to randomization and related to the index procedure (defined as the endovascular procedure from time of first venous access to the removal of the final procedural or device sheath) included any attempt or inadvertent arterial access/puncture with hematoma, procedural complications that could interfere with routine recovery, ambulation or discharge eligibility times, discretionary physician preference for hemostasis approach, physician determination that the patient could not attempt protocol-required ambulation (subjects randomized to MYNX CONTROL VENOUS VCD 6F-12F were required to attempt ambulation within 2 – 2.5 hours from time of final VCD removal
– delay > 2.5 hours was a protocol deviation), venous access site location above the inguinal ligament, intra-procedural bleeding around sheath, suspected intraluminal thrombus, hematoma, pseudoaneurysm or AV fistula, difficult insertion of procedural sheath or needle stick problems (e.g., multiple stick attempts, accidental arterial stick with hematoma, “back wall stick”, etc.), or use of a < 6F or > 12F procedural sheath at any time during the procedure or at closure.
A total of 270 subjects were randomized, 177 to MYNX CONTROL VENOUS VCD 6F-12F and 93 to manual compression with even age distribution (mean 69 years of age) and a larger cohort of men than women (2:1) also evenly distributed in both randomized cohorts.

RELIASEAL CLINICAL TRIAL RESULTS

SAFETY RESULTS
The 177 subjects randomized to MYNX CONTROL VENOUS VCD 6F-12F received 503 devices to close 470 access sites (236 limbs) all with technical device success and zero (0) major complications of the target limb(s) access sites within 30 days. Activated clotting time (ACT) was collected at the conclusion of the procedure with mean ACT for subjects reported as 315.4 ± 89.13 seconds and 326.9 ± 72.19 seconds in the MYNX CONTROL VENOUS VCD 6F-12F group (50/177) and MC group (24/93), respectively. There were no minor complications of the target limb access site within 30 days in the MYNX CONTROL VENOUS VCD 6F-12F group. Minor complications of the target limb access site within 30 days were reported in 5.0% (6 limbs) of the MC group. A clinical events committee (CEC) reviewed major and minor complications. The Major Complications and Minor Complications within 30 days, as adjudicated by the CEC, in all Randomized Subjects are listed in Tables 2 and 3, respectively.

Table 2: CEC Adjudicated Major Complications Directly Attributed to the VCD/Manual Compression within 30 days – Intent to Treat (ITT) Subjects

*Results calculated on a per limb basis

Table 3: CEC Adjudicated Minor Complications Directly Attributed to the VCD/Manual Compression within 30 days – Intent to Treat (ITT) Subjects

*Results calculated on a per limb basis

EFFECTIVENESS RESULTS

Time to Ambulation (TTA) in the MYNX CONTROL VENOUS VCD 6F-12F group was significantly less than in the MC group, with a mean of 2.6 ± 1.03 hours vs. 5.1 ± 4.35 hours, respectively (p < 0.001). In addition, Time to Hemostasis (TTH)
(analyzed per access site) was significantly reduced in the MYNX CONTROL VENOUS VCD 6F-12F subjects compared to the MC (2.1 ± 1.79 minutes vs. 11.4 ± 7.19 minutes, respectively); p < 0.001 demonstrating superiority of the MYNX CONTROL VENOUS VCD 6F-12F over MC for TTA and TTH statistically. Subjects treated with the MYNX CONTROL VENOUS VCD 6F-12F also showed a statistically significant shorter Time to Discharge Eligibility (TTDE/Secondary Effectiveness) compared to subjects treated with MC (3.1 ± 1.24 vs. 5.5 ± 4.58 hours, respectively); p < 0.001. The results of the primary endpoints are presented in Table 4 and the results of the secondary effectiveness endpoints are presented in Tables 5a and 5b.

Table 4: Primary Effectiveness Results (TTA and TTH) – Intent to Treat (ITT) Subjects

Table 5a: Secondary Effectiveness Results (TTDE) – Intent to Treat (ITT) Subjects

Table 5b: Secondary Effectiveness Results (Procedural and Device Success) – Intent to Treat (ITT) Subjects

CLINICAL BENEFITS

Reliable closure of femoral vein access sites

CONCLUSIONS

The results from the ReliaSeal Trial demonstrate that patients who underwent catheter-based procedures utilizing 6F – 12F procedural sheaths, with single or multiple access sites in one or both limbs, and who were treated with the MYNX CONTROL VENOUS VCD 6F-12F have had statistically and clinically significant decreased time to ambulation and time to discharge eligibility when compared to patients treated with manual compression. Additionally, time to hemostasis for MYNX CONTROL VENOUS VCD 6F-12F were superior compared to manual compression.
In addition, the trial demonstrated that the rates of total combined major complications were non-inferior for the MYNX CONTROL VENOUS VCD 6F-12F (0.0%) compared to manual compression (0.8%) patients. The rates of total combined minor complications were lower for MYNX CONTROL VENOUS VCD 6F-12F (0.0%) compared to manual compression (5.0%) patients.
Also, the MYNX CONTROL VENOUS VCD 6F-12F arm demonstrated a high procedural success rate (100%) and a high device success rate (100%).

PROCEDURE AND DEVICE PREPARATION

The techniques and procedures described in these Instructions for Use do not represent all medically acceptable protocols, nor are they intended as a substitute for the physician’s experience and judgment in treating any specific patient.

HOW SUPPLIED

The MYNX CONTROL VENOUS VCD 6F-12F is supplied sterile.

WARNING: Do not use if the MYNX CONTROL VENOUS VCD 6F-12F components or packaging appear to be damaged or defective or if any portion of the packaging has been previously opened.
WARNING: DO NOT REUSE OR RESTERILIZE. The MYNX CONTROL VENOUS VCD 6F-12F is for single use only

The MYNX CONTROL VENOUS VCD 6F-12F includes (Figure 1):

(1) MYNX CONTROL VENOUS VCD 6F-12F including balloon catheter and integrated sealant
(1) 10 ml locking syringe.
Also, included in the packaging: One (1) patient brochure for each device.

PROCEDURE PREPARATION

When using the MYNX CONTROL VENOUS VCD 6F-12F confirm that the procedural sheath is 6F to 12F inner diameter with effective working length not exceeding 12 cm.

WARNING: USE ONLY WITH A STANDARD SHEATH INTRODUCER with up to 12 cm effective length.
WARNING: Do not use MYNX CONTROL VENOUS VCD 6F-12F if a < 6F or > 12F inner diameter procedural sheath is used at closure.
WARNING: The MYNX CONTROL VENOUS VCD 6F-12F is not compatible with Cook Check-Flo™ Performer™ Introducer

PRECAUTION: The MYNX CONTROL VENOUS VCD 6F-12F should not be used in patients with a known allergy to polyethylene glycol (PEG).
NOTE:

• If a patient has had a procedural sheath left in place for an extended period of time, consideration should be given to the use of prophylactic antibiotics before inserting the MYNX CONTROL VENOUS VCD 6F-12F.
• If the puncture is at or below the femoral bifurcation, the balloon may be prepped with a diluted contrast solution (50% contrast / 50% saline), in place of 100% saline in order to visualize the balloon while pulling back to the venotomy and to ensure that the balloon properly abuts the venotomy.
• Do not use 100% contrast solution as this will impact balloon inflation / deflation.

Confirm via imaging prior to using the MYNX CONTROL VENOUS VCD 6F-12F:

• Common femoral vein without posterior wall puncture.
• Evidence of adequate flow.
• No evidence of significant PVD in the vicinity of the puncture.

WARNING: Do not use the MYNX CONTROL VENOUS VCD 6F-12F if the puncture site is located above the inguinal ligament based upon bony landmarks.
WARNING: Do not use MYNX CONTROL VENOUS VCD 6F-12F if the puncture is through the posterior wall

DEVICE PREPARATION AND POSITIONING

• Flush the procedural sheath with sterile heparinized saline.

PRECAUTION: Do not expose lubricated catheter shaft to organic solvents or antiseptic solutions.

• Remove device components from packaging
• Prepare balloon
  • Fill locking syringe with 2 to 3 ml of sterile saline (or a 50/50 saline/contrast mixture if fluoroscopy will be used to confirm balloon positioning), attach to stopcock and draw vacuum.
    • Check Luer connector and tighten if necessary.
• Inflate the balloon until the inflation indicator on the back of the device handle extends so that the entire black marker is fully visible with white border on either side.
  • Check for leaks in the balloon and syringe connector; retighten if necessary.
  • Discard the device if the balloon does not maintain pressure.
  • Check for air bubbles in the balloon. If air bubbles are visible, deflate the balloon and draw vacuum with the syringe to remove bubbles. Re-inflate and re-check the balloon to ensure no air bubbles are present.
  • Deflate the balloon and leave syringe at neutral. Do not lock. (Figure 2)
    

Documents / Resources

Cordis MX61260 Mynx Control Venous Vascular Closure Device [pdf] Installation Guide 6F, 12F, MX61260 Mynx Control Venous Vascular Closure Device, MX61260, Mynx Control Venous Vascular Closure Device, Venous Vascular Closure Device, Vascular Closure Device, Closure Device

References

• User Manual