References:
- 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. MCI-2020-0350
