The MANTA Device is the first commercially available biomechanical vascular closure device designed specifically for large bore femoral arterial access site closure.1 Available in 14 Fr. and 18 Fr., a single MANTA Device effectively closes femoral arterial access sites following the use of sheaths ranging from 12 Fr. to 25 Fr. O.D.2a
Addresses the challenges of large bore closure with a single easy-to-use device.2a
Reduces time to hemostasis without pre-closure, utilizing the coagulation-inducing properties of collagen for rapid hemostasis to promote vessel healing.2c,3-5
Delivers reproducible results and helps inspire confidence in achieving successful closure.2b
The SAFE MANTA IDE Clinical Trial, the largest U.S. prospective, multi-center study
of a purpose-designed large bore femoral arterial access site closure device to
date, demonstrated the safety and effectiveness of the MANTA Device
with all primary and secondary endpoints met.2
INDICATIONS: The 14F MANTA is indicated for closure of femoral arterial access sites following the use of 10-14F devices or sheaths (maximum OD/profile of 18F), and the 18F MANTA device is indicated for closure of femoral arterial access sites following the use of 15-18F devices or sheaths (maximum OD/profile of 25F).
CONTRAINDICATIONS:1) Severe calcification of the access vessel. 2) Severe peripheral artery disease. 3) Puncture in the origin of the profundal femoral artery, above the inguinal ligament, or above the most inferior border of the epigastric artery (IEA). 4) Sheath insertion in vessel other than the femoral 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: 1) Do not use if the temperature indicator dot on package has changed from light gray to dark gray or black. 2) Do not use if the package is damaged or any portion of the package has been previously opened. 3) Do not use if the items in the package appear damaged or defective in any way. 4) Do not REUSE or RESTERILIZE. The MANTA Device is single use only. The MANTA Device contains bioresorbable materials that cannot be reused or re-sterilized. Reuse or re-sterilization may cause degradation to the integrity of the device, leading to device failure which may result in patient injury, illness, or death. 5) Do not use the MANTA Device where bacterial contamination or infection of the target site is suspected. 6) Do not use if there is substantial bleeding around the Depth Locator at the access site during the Depth Location procedure, as this may result in an inaccurate measurement. 7) Do not use if the procedure sheath has been placed through the superficial femoral artery and into the profunda femoris artery, as this may result in collagen deposition into the superficial femoral artery. 8) Do not use if the MANTA delivery system becomes kinked. 9) Do not inflate a contralateral balloon in the femoral or iliac artery during MANTA Sheath exchange or the MANTA Closure procedure. 10) Do not use MANTA if there has been a femoral artery puncture in same vessel within the 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. 11) Do not use if the puncture site is at or distal to the bifurcation of the superficial femoral and profunda femoris artery, as this may result in the a) anchor catching on the bifurcation or being positioned incorrectly, and/or b) collagen deposition into the vessel. 12) Do not use if the puncture site is proximal to the inguinal ligament or above the most inferior border of the epigastric artery (IEA), as this may result in retroperitoneal bleeding. 13) Difficult dilation of the puncture tract due to scar tissue may lead to swelling of surrounding tissue, thus compromising the accuracy of the puncture depth determined during the depth location procedure.
PRECAUTIONS: 1) The MANTA Device should only be used by a licensed physician or healthcare provider trained in the use of this device. 2) The MANTA Device should not be used in patients with known allergies to bovine products, collagen and/or collagen products, or polyglycolic or polylactic acid polymers. 3) The MANTA Device should not be used in patients with known allergy to stainless steel or nickel. See MRI information in these instructions for use.
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, and its consequences, as a result of failed closure in the setting of an access above the inguinal ligament or the most inferior border of the epigastric artery (IEA). 4) Perforation of iliofemoral 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) Adjacent 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.