- Data on file at Teleflex.
- Data on file at Teleflex. The SAFE MANTA IDE Clinical Trial.
a. A single MANTA Vascular Closure Device was deployed in 99.6% of subjects in IDE trial.
b. 97.7% Technical Success, defined as percutaneous vascular closure obtained with the MANTA< Device without the use of unplanned endovascular or surgical intervention.
c. The MANTA Device demonstrated a time to hemostasis (TTH) of 24 seconds median time (65 seconds mean time) from deployment to hemostasis, which is lower than published rates for Perclose ProGlide® where Perclose ProGlide® demonstrated a TTH of 9.8 +/- 17 minutes (588 +/- 1,020 seconds).3
d. Major Complications defined as composite of: i) vascular injury requiring surgical repair/stent-graft; ii) bleeding requiring transfusion; iii) lower extremity ischemia requiring surgical repair/additional percutaneous intervention; iv) nerve injury (permanent or requiring surgical repair); and v) infection requiring IV antibiotics and/or extended hospitalization.
Study sponsored by Teleflex Incorporated or its affiliates.
- Nelson PR, et al. A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial). J Vasc Surg. 2014 May;59(5):1081-1193.
- Farndale RW, Sixma JJ, Barnes MJ, de Groot, PG. The role of collagen in thrombosis and hemostasis, J Thromb Haemost. 2004 Apr,2(4);564-573.
- Nuyttens BP, Thijs T, Deckmyn H, Broos K. Platelet adhesion to collagen, Thromb Res. 2011;127(2); S26-S29.
- Généreux P, et al. Vascular complications after transcatheter aortic valve replacement. J Am Coll Cardiol. 2012 Sept 18;60(12):1043-1052.
- Lauten A, et al. Percutaneous left-ventricular support with the Impella 2.5-assist device in acute cardiogenic shock: results of the Impella-EUROSHOCK-registry. Circ Heart Fail. 2013 Jan;6(1):23-30.
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 or 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: 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.
Please see the Instructions for Use for a complete listing of the indications, contraindications, warnings and precautions. Not all products are available in all regions. Please contact customer service to confirm availability in your region. Teleflex, the Teleflex logo, and MANTA are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. All other trademarks or registered trademarks are property of their respective owners.