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. Manta ultrasound-guided closure is intended to be an alternative method to the conventional preprocedural depth-locator measurement technique to provide additional procedural flexibility to operators.

According to the company, the prospective, multicenter, single-arm MANTA ULTRA study will be composed of patients undergoing elective transcatheter aortic valve replacement procedures with planned percutaneous femoral arterial access. Up to 150 patients will be enrolled at up to 15 investigational sites across the United States and Canada.

The Principal Investigators of the study include David A. Wood, MD, and Vijay S. Iyer, MD. Dr. Wood is Head, VGH Division of Cardiology and Director, University of British Columbia Centre for Cardiovascular Innovation in Vancouver, Canada. Dr. Iyer is Chief, Cardiovascular Medicine and Associate Professor of Medicine at the University of Buffalo in Buffalo, New York.

The primary safety endpoint is any large-bore access site–related Valve Academic Research Consortium-2 (VARC-2) major vascular complication within 30 days (adapted from VARC-2 criteria).

Additionally, the study will employ a secondary endpoint of any large-bore access site–related VARC-2 minor vascular complication within 30 days (adapted from VARC-2 criteria) and secondary effectiveness endpoints that include time to hemostasis, technical success, ambulation success, time to ambulation, treatment success, and procedure time—all with 30-day and 12-month follow-up time points.

The company seeks to determine whether the known benefits of ultrasound-guided access will translate to ultrasound-guided closure, resulting in safe Manta device deployment. With visualization of the access site during Manta device deployment, the study intends to demonstrate that ultrasound allows for precise deployment and positive positioning of the Manta device anchor within the vessel.

This approach, if proven effective, will allow the Manta device to be used in clinical scenarios where the baseline arterial depth is not measured or may have changed intraoperatively or postoperatively, stated Teleflex.

“We’re excited to embark on the Teleflex MANTA ULTRA study,” commented Dr. Wood in the company’s press release. “We expect the study results to show that the use of ultrasound further aids in avoiding Manta device deployment complications attributed to anchor malpositioning by providing direct visualization of the closure process.”