Arrow ErgoPack and AC3 Optimus Product Overview
MantaⓇ Vascular Closure Device
A new era of simplicity and confidence in large bore closure
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 large bore sheaths
ranging from 12 Fr. to 25 Fr. O.D. 2b
Simple deployment
Addresses the challenges of femoral arterial access site closure with a single easy-to-use
device.2b
Rapid hemostasis
Reduces time to hemostasis without pre-closure, utilizing the coagulation-inducing
properties of collagen for rapid hemostasis to promote vessel healing. 2c,3-5
Reliable closure
Delivers reproducible results and helps inspire confidence in achieving successful
closure.2d
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1. Data on file at Teleflex. 2. Data on file at Teleflex. The SAFE MANTA IDE Clinical Trial. 2a. 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. 2b. A single MANTATM Device was deployed in 99.6% of subjects in
the IDE trial. 2c. The MANTAT 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 +/- d. 17 minutes (588 +/- 1,020 seconds). 3 97.7% Technical Success, defined as percutaneous vascular closure obtained with the MANTATM Device without the use of unplanned endovascular or surgical intervention.
Study sponsored by Teleflex Incorporated or its affiliates.
3. 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.
4. Farndale RW, et al. The role of collagen in thrombosis and hemostasis. J Thromb Haemost. 2004 Apr;2(4):564-573. 5. Nuyttens BP, et al. Platelet adhesion to collagen. Thromb Res. 2011;127(2): S26-S29.
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