Teleflex Announces First Patient Enrollment in MANTA Ultra Study
Excerpt from the Press Release:
Study Intends to Demonstrate that Ultrasound Allows for Precise Deployment and Positive Positioning of the MANTA® Vascular Closure Device
WAYNE, Pa., June 22, 2022 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the first patient enrollment in a clinical study that is intended to demonstrate the safety of MANTA® Vascular Closure Device ultrasound (U/S) guided closure, without dependence on the pre-procedural depth locator measurements. The study will enroll patients undergoing elective TAVR procedures with planned percutaneous femoral arterial access.
Enrolling up to 150 patients in up to 15 investigational sites across the US and Canada, the MANTA Ultra Study is a prospective, multi-center, single-arm trial employing the primary safety endpoint of any large bore access-site related Valve Academic Research Consortium-2 (VARC-2) Major Vascular Complication within 30 days (adapted from VARC-2 Criteria).The occurrence of access site complications is known to be associated with higher rates of morbidity and mortality1 and increased costs associated with prolonged length of stay.2
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