September 16, 2022 — Incorporated Teleflexone of the world’s leading medical technology providers, announced that Dr. Magnus Settergrenassociate professor at the Karolinska InstituteInterventional Cardiologist at Karolinska University Hospital, and co-author of the percutaneous plug-based vascular closure device study in 1000 consecutive transcatheter transfemoral aortic valve implantations, is scheduled to present in a Teleflex-sponsored training pavilion at the Transcatheter Cardiovascular Therapeutics conference. (TCT) this Sunday, September 18, 2022 at 10:00 a.m. (ET). TCT is the Cardiovascular Research Foundation (CRF) annual scientific symposium and the world’s largest educational forum specializing in interventional cardiovascular medicine.
The follow-up study of the Karolinska 1000 MANTA device— the largest ever real-world evaluation of the MANTA device — demonstrated safety and efficacy with low complication rates and a short learning curve.1 The results of this study were published in The International Journal of Cardiology.
This single-center observational study investigated 1048 consecutive unselected subjects undergoing transcatheter transfemoral aortic valve implantation (TAVI) from May 2017 to September 2020 at Karolinska University Hospital in Stockholm, Sweden. The 18 French MANTA Device was used by five operators to close the femoral artery access site in 1000 subjects (48 excluded), the primary outcome being the measurement of major complications related to the vascular closure device (VCD) according to the Valve Academic Research Consortium (VARC)-2 defining criteria.1
The study, which was not sponsored by Teleflex, demonstrated that major vascular complications related to the MANTA device occurred in 4.2% of patients with no significant difference in preoperative characteristics between patients with and without major vascular complications linked to the MANTA.1 device This result is consistent with the results of the SAFE MANTA IDE clinical trial, published in 2019 in Circulation: Cardiovascular Interventionswhich demonstrated a VARC-2 major vascular complication rate of 4.2%, as well as The MARVEL Prospective Registry, published in 2020 in Catheterization and Cardiovascular Procedureswhich demonstrated a VARC-2 major vascular complication rate of 4.0%.2,3
“As interventionists, we often hear that one of the advanced advantages of the MANTA device over suture-based VCDs is a comparatively shorter learning curve; however, few studies have included learning curve analysis,” Dr. Settergren said. “Our study found no significant difference in major complications between interventionists, either in their first 20 deployments of MANTA devices, or even in 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 consistent with our user experience. I look forward to presenting the lessons learned from this real-world experience to my TCT colleagues this weekend,” Dr. Settergren concluded.
About the MANTA Vascular Closure Device
The MANTA device is the first commercially available biomechanical vascular closure device designed specifically for closure of the large bore femoral arterial access site. The MANTA device has now sold 100,000 units worldwide with over 6 years of commercial clinical experience. The device has been studied in more than 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 plug-based vascular closure device in 1000 consecutive transcatheter transfemoral aortic valve implantations. International Journal of Cardiology. 2022; Flight 359. https://doi.org/10.1016/j.ijcard.2022.04.033
- The SAFE MANTA IDE clinical trial. Study sponsored by Teleflex Incorporated or its affiliates.
- Kroon HG, Tonino PAL, Savontaus M, et al. Dedicated plug-based closure for big-bore access – The forward-looking MARVEL damper. Cardiovascular Catheter Interv. 2020;1–9. https://doi.org/10.1002/ccd.29439
- Data on file with Teleflex.
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