MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study

The MANTA device is a VCD intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F ID) interventional devices. The function of MANTA is to percutaneously close the puncture in the artery wall (arteriotomy) through which the catheters were inserted for the procedure.

The study is being conducted to demonstrate the safety and effectiveness of MANTA in achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous transcatheter interventional procedures using a large-bore procedure sheath.

Inclusion criteria

• Candidate for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedure via a 10-18F size retrograde common femoral artery approach (i.e., transcatheter aortic valve implantation [TAVI], endovascular aneurysm repair [EVAR], Impella® use)
• Vessel size would allow for access for the MANTA device as determined by baseline CTA: minimum vessel diameter 5mm for the 14F MANTA and 6mm for the 18F MANTA
• Eligible for sheath removal in the catheterization lab
• Age ≥21 years
• Understand and sign the study specific written informed consent form
• Able and willing to fulfill the follow-up requirements
• In the investigator's opinion, patient is suitable for the MANTA vascular closure device, conventional hemostasis techniques and participation in an investigational trial

Exclusion criteria

• Known to be pregnant or lactating
• Immunocompromised or with pre-existing autoimmune disease
• Systemic infection or a local infection at or near the access site
• Significant anemia (hemoglobin <10 g/DL, hematocrit <30%)
• Morbidly obese or cachectic (BMI >40 kg/m2 or <20 kg/m2)
• Known bleeding disorder including thrombocytopenia (platelet count <100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease
• Allergy to bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel
• Femoral artery puncture in target groin within the prior 14 days
• Previous iliofemoral intervention in region of access site, including but not limited to prior atherectomy, stenting, surgical or grafting procedures in the access area
• Patients who have undergone use of an intra-aortic balloon pump through the arterial access site within 30 days prior to the baseline evaluation
• Patients who are not mobile and are confined to a wheelchair or bed
• NYHA class IV heart failure
• Patients who have already participated in the IDE study
• Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period
• Patient cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life threatening disease