September 16, 2022 – Teleflex Incorporateda leading global provider of medical technologies, announced that Dr. Magnus Sittergreenassociate professor at Karolinska InstituteInterventional Cardiologist at Karolinska University Hospitaland co-author of the percutaneous vascular closure device at 1,000 consecutive tons through the thighcatheter Aortic valve implantation The study is scheduled to be presented in a training booth sponsored by Teleflex in Cardiovascular treatments via catheterization (TCT) on Sunday, September 18, 2022 at 10:00 a.m. (ET). TCT is a file Cardiovascular Research Foundation (CRF) The annual scientific symposium and the world’s first educational forum for interventional cardiovascular medicine.
Karolinska 1000 Series MANTA . StudyMANTA’s largest real-world rating has demonstrated safety and efficacy with low complication rates and a short learning curve. The results of this study were published in International Journal of Cardiology.
This single-center, observational study reviewed 1048 consecutive, unselected subjects undergoing transoral transcatheter aortic valve transplantation (TAVI) from May 2017 to September 2020 at Karolinska University Hospital in Stockholm, Sweden. The French MANTA 18 device was used by five operators to occlude the femoral artery access site in 1,000 subjects (48 excluded), the primary outcome being the measurement of major complications related to the vascular occlusion device (VCD) according to the Valve Academic Research Consortium (VARC Definition Standards) -2
The study, which was not sponsored by Teleflex, showed that major vascular complications related to the MANTA device occurred in 4.2% of patients with no significant differences in preoperative characteristics between patients with and without major vascular complications associated with and without the MANTA device. Results of the SAFE MANTA IDE clinical trial, published in 2019 in Circulation: Cardiovascular Interventionswhich showed a major vascular complication rate for VARC-2 of 4.2%, as well as the MARVEL Prospective Registry, published in 2020 in Catheterization and Cardiovascular Interventionswhich showed a 4.0% VARC-2 for major vascular complications
“As an interventionist, we often hear that one of the argumentative benefits of MANTA compared to thread-based VCDs is a relatively shorter learning curve; however, few studies have included learning curve analysis,” said Dr. Settergren. “Our study did not find significant differences in major complications between the two interventions, either in the first 20 deployments of the MANTA device, or even across the first 100 procedures at the center.”
“The results of our study indicate that the MANTA device is easy to learn and has a short learning curve, which is in line with our user experience. I look forward to presenting what we learned from this real-world experience to my colleagues at TCT this weekend,”
About MANTA Vascular Closure Device
The MANTA device is the first commercially available biomechanical vascular occlusion device specifically designed to close the access site of the large femoral arteries. MANTA has now sold 100,000 units globally with over 6 years of commercial clinical experience. The device has been studied in over 35 clinical studies – 25 of which focused on TAVI/TAVR.4
for more information: https://www.teleflex.com/usa/en/
- Kastengren, M, Settergren, M, et al. Percutaneous vascular closure device in 1,000 consecutive transfemoral transcatheter aortic valve implantations. International Journal of Cardiology. 2022; Volume 359. https://doi.org/10.1016/j.ijcard.2022.04.033
- The SAFE MANTA IDE clinical trial. The study is sponsored by Teleflex Incorporated or its affiliates.
- Crohn HG, Tonino Ball, Savontos M, et al. Custom plug-based closures to access the big bore – MARVEL’s highly anticipated record. Cardiovasc Interv catheter. 2020; 1-9. https://doi.org/10.1002/ccd.29439
- The data is on file in Teleflex.