The study intends to show that ultrasound enables accurate deployment and stable positioning of the MANTA Vascular Closure Device
Medical technology company Teleflex has recruited the first patient in a clinical study to evaluate the safety of MANTA Vascular Closure Device ultrasound (U/S) guided closure without relying on pre-procedural depth locator measurements.
Teleflex said that the patients undergoing elective TAVR surgeries with intended percutaneous femoral arterial access will be recruited in the study.
The MANTA Ultra Study is a prospective, multi-centre, single-arm trial that will enrol up to 150 patients in up to 15 investigational sites across the US and Canada.
It employs the primary safety endpoint of any large bore access-site related Valve Academic Research Consortium-2 (VARC-2) Major Vascular Complication within 30 days
The use of ultrasound-guided access can result in a lower risk of life-threatening, major, and minor access site haemorrhage problems, as well as a lower risk of major and minor vascular complications at the access site.
The study also aims to show that ultrasound enables accurate deployment and positive positioning of the MANTA Device anchor within the vessel through visualisation of the access site during MANTA Device deployment.
If successful, the method will enable the MANTA Device to be used in clinical situations when the baseline arterial depth is unknown or may have changed during or after surgery.
The pre-procedural depth locator measurement approach is expected to be replaced by the MANTA Device ultrasound-guided closure, which can give surgeons more procedural flexibility.
Teleflex medical director Chris Buller said: “The resourcing of the MANTA Ultra Study by Teleflex reflects our commitment to providing interventional cardiologists and surgeons with category-defining tools that enable difficult procedures and minimise complications – in this case, the complications attributable to large bore access that are inherent to TAVI procedures.”
The study will also employ a secondary endpoint of any large bore access-site related VARC-2 minor vascular complication within 30 days and secondary effectiveness endpoints, which include time to haemostasis, ambulation success, technical success, time to ambulation, treatment success and procedure time – all with 30-day and 12-month follow-up time points.
Last month, the company received approval from Health Canada for its MANTA Vascular Closure Device.