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FDA Approves IDE for Trial of Essential Medical's Manta Large-Bore Vascular Closure Device

July 8, 2016—Essential Medical, Inc. announced that it has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin the United States clinical trial for Manta, the company’s large-bore vascular closure device.

Results Presented From Pivotal Trial of Essential Medical's Manta Vascular Closure Device

June 25, 2018—Essential Medical, Inc. announced the results from the pivotal SAFE MANTA investigational device exemption (IDE) clinical trial, which is evaluating the company's Manta dedicated large-bore vascular closure device.

Teleflex's Manta Device Receives FDA Premarket Approval for Large-Bore Femoral Arterial Access Site Closure

February 5, 2019—Teleflex Incorporated announced its Manta vascular closure device has received FDA premarket approval (PMA).

Teleflex’s MANTA ULTRA Study Begins Enrollment

June 22, 2022—Teleflex Incorporated announced that the first patient was enrolled in the MANTA ULTRA clinical study, which seeks to demonstrate the safety of ultrasound-guided closure with the company’s Manta vascular closure device without dependence on preprocedural depth-locator measurements.

Teleflex Manta Vascular Closure Device Approved in Canada

May 18, 2022—Teleflex Incorporated announced that it received Health Canada approval for the Manta vascular closure device, which is designed specifically for large-bore femoral arterial access site closure.

Essential Medical's Manta Large-Bore Vascular Closure Device Approved in Europe

July 18, 2016—Essential Medical, Inc. announced that it has received European CE Mark approval for the company’s Manta large-bore vascular closure device.

Teleflex Commences Enrollment in ACCESS-MANTA Registry

November 16, 2023—Teleflex Incorporated announced the first patient enrollment in a clinical registry that is intended to examine and collect data on outcomes of contemporary on-label use of the company’s Manta vascular closure device (VCD) in transcatheter aortic valve replacement (TAVR) procedures.

European Studies Begin for Essential Medical's Manta Large-Bore Vascular Closure Device

July 27, 2015—Essential Medical, Inc. announced that it has commenced European clinical studies using its Manta large-bore vascular closure device, which is designed to seal both 14-F and 18-F large-bore femoral punctures. The Manta device closes femoral arterial punctures made during cardiac catheterization procedures such as transcatheter aortic valve replacement, endovascular treatment of abdominal aortic aneurysms, ventricular assist, and balloon aortic valvuloplasty.

Safety and Efficacy Data Published for Teleflex's Manta Closure Device

July 12, 2019—Findings from SAFE MANTA, the pivotal clinical study to evaluate the safety and effectiveness of the Manta percutaneous vascular closure device (Teleflex), were published by David A. Wood, MD, et al in Circulation: Cardiovascular Interventions.

European Postmarket Registry Begins for Essential Medical's Manta Large-Bore Vascular Closure Device

October 9, 2017—Essential Medical, Inc. announced the initiation of enrollment in a postmarket clinical registry of the company's Manta large-bore vascular closure device to be conducted in the regions where the device commercially available.

Essential Medical to Seek FDA Approval of Manta Large-Bore Vascular Closure Device

January 8, 2018—Essential Medical, Inc. announced the completion of 60-day follow-up for the MANTA United States pivotal study of the company's Manta vascular closure device.

United States Pivotal Trial Begins for Essential Medical's Manta Vascular Closure Device

December 12, 2016–Essential Medical, Inc. announced the start of the MANTA United States pivotal trial for the company's Manta vascular closure device.

CE Mark Approval Data Published for Essential Medical's Manta Large-Bore Vascular Closure Device

April 3, 2017—Essential Medical, Inc. announced the publication of the CE Mark approval study of the Manta vascular closure device, "Percutaneous Plug-Based Arteriotomy Closure Device for Large-Bore Access" by Nicolas M. Van Mieghem, MD, et al in Journal of the American College of Cardiology: Cardiovascular Interventions.

Enrollment Completed in Pivotal Trial of Essential Medical's Manta Large-Bore Vascular Closure Device

October 2, 2017—Essential Medical, Inc. announced the completion of enrollment in the United States pivotal trial of its Manta large-bore vascular closure device.

Enrollment Completed in EU Clinical Studies for Essential Medical's Manta Large-Bore Vascular Closure Device

February 1, 2016—Essential Medical, Inc. announced that it has completed enrollment of its European CE Mark clinical study of Manta, the company's large-bore vascular closure device.