Safety and efficacy of the Mynx Control vascular closure device in peripheral arterial procedures: A prospective study

Vascular ◽  
2021 ◽  
pp. 170853812110627
Author(s):  
Athanasios Diamantopoulos ◽  
Romman Nourzaie ◽  
Doug Mulholland ◽  
Steven G Dolan ◽  
Irfan Ahmed ◽  
...  

Objectives This article aims to present a prospective study investigating the safety and efficacy of the Mynx Control extravascular closure device (Cordis Corporation, FL, USA), for femoral arterial closure in patients undergoing peripheral arterial procedures. Methods Between January 2020 and February 2021, 100 Mynx Control devices were deployed in 91 consecutive patients (mean age: 67.5 ± 16.9 years) who underwent peripheral arterial procedures. We used ultrasound and/or fluoroscopy during Mynx Control deployment and ultrasound post-procedure to detect complications. Femoral artery punctures included 62 (62%) antegrade and 38 (38%) retrograde punctures. The mean activated clotting time at time of device deployment was 221s. The primary endpoints were technical success, device failure, and complication rates up to 30 days. Results A 5F vascular sheath was used in 43 cases (43%) (36 (36%) 6F and 21 (21%) 7F). The majority of our cases had antegrade access (62%). Overall technical success rate was 97% in both antegrade and retrograde cases. In total, there were 4 minor complications: 3 (3%) cases of pseudoaneurysm and 1 (1%) case of haematoma. No major complications were recorded post-procedure or 30 days post index procedure. Conclusion The Mynx Control vascular closure device is safe and effective in achieving haemostasis in patients undergoing antegrade and retrograde peripheral angioplasty procedures.

2014 ◽  
Vol 21 (6) ◽  
pp. 822-828 ◽  
Author(s):  
Kaffer Kara ◽  
Amir A. Mahabadi ◽  
Hanna Rothe ◽  
Patrick Müller ◽  
Jan Krüger ◽  
...  

Gut and Liver ◽  
2015 ◽  
Vol 9 (2) ◽  
pp. 239-246 ◽  
Author(s):  
Kei Yane ◽  
Hiroyuki Maguchi ◽  
Akio Katanuma ◽  
Kuniyuki Takahashi ◽  
Manabu Osanai ◽  
...  

Vascular ◽  
2021 ◽  
pp. 170853812110378
Author(s):  
Sullivan A Ayuso ◽  
R Caroline Shipp ◽  
Bola G Aladegbami ◽  
Delton Farquharson ◽  
Denny Lawson ◽  
...  

Objectives Vascular closure devices (VCDs) are widely used for arteriotomy closure after percutaneous catheter–based procedures. In comparison to manual compression, VCDs have been associated with shorter time to hemostasis, shorter time to ambulation, and also decreased length of stay. Complexity of deployment, lack of immediate hemostasis, and residual deformity of the arterial wall remain as limitations of current VCDs. The aim of this study was to investigate the AbsorbaSeal™ 5.6.7F vascular closure device, a novel, completely bioabsorbable, intuitive, and easy to use VCD which uses a compressive, “sandwich”-type design comprising a low profile intravascular distal seal and gasket and an extravascular floating foot and proximal seal, in an open infrarenal aortic swine model. Methods Eight fully heparinized swine at a good laboratory practices facility underwent AbsorbaSeal™ 5.6.7F VCD closure of three 6F arteriotomies each in the proximal, mid, and distal infrarenal aorta. Two swine underwent harvest at each of four time cohorts: 30, 60, 90, and 120 days. Acute and chronic procedural safety and efficacy, as well as target site vascular remodeling over time, were the primary outcomes evaluated. Secondary outcome measures included local and systemic inflammatory responses, end-organ tissue analysis, and device-related complications through the follow-up periods. Histopathological evaluation was performed by a blinded pathologist. Standard statistical methods were used. Results In deployment of 24 AbsorbaSeal™ 5.6.7F VCDs, there were no device-related complications or mortalities. All deployments resulted in rapid arteriotomy seal (100% deployment success), with a mean time to hemostasis (cessation of arterial flow) of 21.5 s (median: 6.5 s) across a mean activated clotting time (ACT) of 356 s. Twenty of the 24 implant sites (83%) attained complete hemostasis within 20 s. Immediate post-implant and pre-termination angiographies at all time points were performed of all swine which demonstrated normal aortic appearance and tissue structure and normal downstream vascular beds. At 30 days, each implant’s intravascular distal seal and gasket were removed from the circulation and completely covered with a smooth neointimal layer. Minimal inflammation and no intimal or luminal thrombus were observed at any site at every time point. Conclusions AbsorbaSeal™ 5.6.7F is a safe, effective, and secure VCD that demonstrates rapid hemostasis in a fully heparinized open aortic porcine model. Removal from circulation and complete coverage of the intravascular distal seal and gasket with neointima occurred within 30 days post-implant. Natural transmural vessel healing from the arteriotomy itself with minimal inflammation was noted for each implant at every time point.


2009 ◽  
Vol 8 (8) ◽  
pp. 666-667
Author(s):  
J. Neymeyer ◽  
W. Abdul-Wahab Al-Ansari ◽  
C. Baecker ◽  
B. Mueller ◽  
M. Abou-Dakn ◽  
...  

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