Manta Vascular Closure Device
• Fast, reliable biomechanical closure1
• Simple deployment with rapid hemostasis1
• Single device that doesn’t require preclosure1,2
• Low complication rates1
• Saves time, potentially reducing costs1
The Manta vascular closure device is indicated for closure of femoral arterial access sites while reducing time to hemostasis (TTH) following the use of 10- to 20-F devices or sheaths (12- to 25-F outer diameter) in endovascular catheterization procedures.
The SAFE MANTA investigational device exemption (IDE) clinical trial* demonstrated that the Manta device successfully achieves fast, reliable biomechanical closure with rapid hemostasis (median TTH, 24 seconds [mean, 65 seconds]) and that all primary and secondary endpoints were met. A major complication rate, defined as a composite of vascular injury requiring surgical repair/stent graft, bleeding requiring transfusion, lower extremity ischemia requiring surgical repair/additional percutaneous intervention, nerve injury (permanent or requiring surgical repair), and infection requiring intravenous antibiotics and/or extended hospitalization, of 5.3% and a Valve Academic Research Consortium-2 major vascular complication rate of 4.2% were also reported. A single Manta vascular closure device was deployed in 99.6% of participants in the SAFE MANTA IDE trial. The device has the potential to reduce bleeding complications and offset other procedural costs.1
The Manta device has received CE Mark approval and FDA premarket approval
*The SAFE MANTA IDE clinical trial was sponsored by Teleflex Incorporated or its affiliates.
1. SAFE MANTA IDE clinical trial. Data on file at Teleflex.
2. Nelson PR, Kracjer Z, Kansal N, 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;59:1081-1193.
MC-005318 Rev 1