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INSTRUCTIONS FOR USE - MANTA
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While maintaining neutral digital pressure at the puncture with the fingers of the left hand, withdraw the MANTA slowly and carefully from the
patient along the angle of puncture, approximately 45 degrees (Figure 13).
NOTE: DO NOT apply compressive or occlusive manual/digital pressure to the vessel while rotating lever, releasing the toggle, or withdrawing
the MANTA device. Only support the skin enough to prevent distension of the vessel.
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Continue to withdraw the MANTA Closure until the tension gauge begins to show YELLOW/GREEN in the tension window (Figure 14). The BLUE lock
advancement tube will emerge (Figure 15).
NOTE: DO NOT pull past GREEN. Excessive force may cause vessel damage. Only light tension (YELLOW/GREEN) is required.
The collagen plug has now been deployed, and the lock must be advanced to fully seal:
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MAINTAIN constant YELLOW/GREEN tension while the BLUE lock advancement tube emerges from the MANTA Closure (Figure 15). Note that the
tension gauge indicator will show a RED zone when excessive force is applied.
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While maintaining light tension as indicated by the YELLOW/GREEN to full GREEN indicator, grasp the BLUE lock advancement tube.
Maintain
YELLOW/GREEN
Tension
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Lightly slide the BLUE lock advancement tube down the suture and advance the stainless steel lock distally to secure the implant (Figure 16),
maintaining constant tension (indicator showing GREEN) on the MANTA Closure handle with the right hand.
•
While maintaining the position of the BLUE lock advancement tube, increase tension on the MANTA Closure handle slightly, until an audible click is
heard.
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Relax upward tension on the MANTA Closure handle. Slide the BLUE lock advancement tube up the suture and out of the puncture tract. Observe
the puncture site and confirm hemostasis.
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If pulsatile arterial bleeding (greater than subcutaneous oozing) persists, advance the BLUE lock advancement tube a second time after achieving
GREEN/YELLOW tension on the MANTA handle. If bleeding is non-pulsatile, DO NOT perform a second lock advancement. Apply manual pressure to
facilitate hemostasis.
NOTE: With tension removed, a visible GRAY indicator band at the proximal tip of the delivery tube will confirm the lock is fully advanced and the
collagen is compacted (Figure 17).
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If hemostasis has still not been achieved, additional manual pressure should facilitate hemostasis.
NOTE: A femoral angiogram may be performed to confirm patency and lack of extravasation.
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Once arterial hemostasis has been achieved, remove the guidewire.
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Press down on the skin at the puncture tract and cut the suture below the level of the skin (Figure 18).
NOTE: Visible suture at skin level may lead to infection.
A small sterile dressing or pressure bandage may be applied to the access site as needed.
Figure 17 – Note GRAY Indicator Band, Indicates Full Collagen Compaction
Recatheterization/Reintervention
In the event that a patient requires reintervention after a MANTA Closure has been placed:
Using X-ray, locate the existing MANTA Closure Device(s), visible by the small radiopaque marker.
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Select a puncture site on the common femoral artery at least 2.5 cm above or below the existing MANTA Closure Device(s) to avoid interference
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from scar tissue or unresorbed MANTA components.
NOTE: When selecting puncture site, take care to observe "Warnings" section above.
Proceed with device deployment per "Device Use Steps" above.
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PRODUCT INFORMATION DISCLOSURE
Essential Medical, Inc. has taken reasonable care in the manufacture of MANTA and excludes all warranties, expressed or implied, by operation of law or
otherwise, including but not limited to any implied warranties of merchantability or fitness, since handling or storage of this device as well as factors relating
to the patient, diagnosis, treatment, surgical procedures, and other matters beyond Essential Medical, Inc.'s control directly affect the MANTA and the result
obtained from its use. Essential Medical, Inc. shall not be liable for any incidental or consequential loss, damage, or expense, directly or indirectly arising
from use of MANTA. Essential Medical, Inc. neither assumes, nor authorizes any other person to assume for it, any other additional liability or responsibility
in connection with MANTA.
MRI Safety Information:
Non-clinical testing demonstrated that the MANTA is MR Conditional. A patient with this device can be scanned safely in an MR system under the following
conditions:
Static magnetic fields of 1.5-Tesla and 3-Tesla
o
Maximum spatial gradient magnetic field of 4,000-gauss/cm (40-T/m) or less
o
Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4-W/kg for 15 minutes of scanning (i.e., per
o
pulse sequence) in the First Level Controlled Operating Mode
Under the scan conditions defined for, the MANTA is expected to produce a maximum temperature rise of 2.4°C after 15-minutes of continuous scanning
(i.e., per pulse sequence).
Artifact Information
In non-clinical testing, the image artifact caused by the MANTA extends approximately 10-mm from the MANTA when imaged using a gradient echo pulse
sequence and a 3-Tesla MR system.
LBL-001 REV. A
2018/01
Figure 13 – Deploy Along Angle of Tract
Figure 14 – Tension Gauge Visual
YELLOW
Tension
Gauge
Figure 15 – Collagen Deployment Prior to Advancing Lock
3: Hold Lock;
Pull Right Hand
to Click
2: Lightly
Advance Lock
Guidewire
Removed AFTER
Advancing Lock
Figure 16 – Pull to Tension Indicator and Advance Lock
GRAY
BLUE Lock Advancement
Tube
YELLOW
Tension
Gauge
GREEN
Withdraw Handle
and Sheath to
Deploy Closure
BLUE Lock Advancement
Tube
1: MAINTAIN
YELLOW/GREEN
to Full GREEN
Tension
ADVANCING LOCK
Figure 18 – Cut Suture below Skin
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