MANTA Vascular Closure Device

MANTA Vascular Closure Device

A new era of simplicity and confidence in closure is here

The MANTA Device is the first commercially available biomechanical vascular closure device

designed specifically for large bore femoral arterial access site closure.

Simple deployment

     Addresses the challenges of large bore closure with a single easy-to-use device.

Rapid haemostasis

      Reduces time to haemostasis without pre-closure, utilizing the coagulation-inducing    properties of collagen for rapid haemostasis to promote vessel healing.

     Reliable closure

     Delivers reproducible results and helps inspire confidence in achieving successful closure.

     Engineered for versatility

Contraindications:

1.      Severe calcification of the access vessel

2.      Severe peripheral artery disease

3.      Puncture in the origin of the profundal femoral

4.      Sheath insertion in vessel other than the femoral artery, above the inguinal ligament, or above the most inferior border of the epigastric artery (IEA) artery

5.      Marked tortuosity of the femoral or iliac artery

6.      Marked obesity or cachexia (BMI >40 or <20)

7.      Blood pressure >180 mmHg

8.      Patients who cannot be anti-coagulated for the procedure

Warnings: Do not use:

1.      If bacterial contamination of procedure sheath or surrounding tissues may have occurred.

2.       If the procedure sheath has been placed through the superficial femoral artery and into the profunda femoris artery.

3.      If the MANTA Device delivery system becomes kinked

4.      with a contralateral balloon inflated in the femoral or iliac artery during MANTA device use

5.      If there has been a femoral artery puncture in same vessel within prior 30 days, recent femoral artery puncture in same groin that has not healed appropriately, and/or recent (<30 days) vascular closure device placement in same femoral artery.

6.      If puncture site is at or distal to bifurcation of superficial femoral and profunda femoris artery.

7.      If the puncture site is proximal to inguinal ligament or above most inferior border of epigastric artery (IEA).

Potential Adverse Events:

1.      Failed hemostasis requiring manual or mechanical compression, application of balloon pressure from a secondary access site, placement of a covered stent or surgical repair.

2.      Local trauma to the femoral or iliac artery wall, such as dissection.

3.      Retroperitoneal bleeding as a result of access above the inguinal ligament or the most inferior border of the epigastric artery (IEA).

4.      Perforation of ileofemoral arteries, causing bleeding/hemorrhage.

5.      Accidental positioning of some or all of the collagen plug within the femoral artery, leading to ischemia or stenosis.

6.      Thrombosis formation or embolism.

7.      Nerve damage or neuropathy.

8.      Other access site complications leading to bleeding, hematoma, pseudoaneurysm, etc., possibly requiring blood transfusion, surgical repair, and/or endovascular intervention.