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AbsorbaSeal™ 5.6.7F vascular closure device: A good laboratory practice chronic study evaluating safety and efficacy
Sullivan A Ayuso1, R Caroline Shipp2, Bola G Aladegbami1
1Division of Gastrointestinal and Minimally Invasive Surgery, Department of Surgery, 22442Carolinas Medical Center, Charlotte, NC, USA.
Insights
The novel AbsorbaSeal™ vascular closure device (VCD) demonstrated rapid hemostasis and excellent safety in a swine model. This bioabsorbable device achieved complete seal within seconds, with complete tissue integration by 30 days.
Area of Science:
- Vascular Surgery
- Biomaterials Science
- Interventional Cardiology
Background:
- Vascular closure devices (VCDs) offer advantages over manual compression for arteriotomy closure, including reduced ambulation time and hospital stay.
- Current VCDs face limitations such as deployment complexity, delayed hemostasis, and potential arterial wall deformities.
Purpose of the Study:
- To evaluate the safety and efficacy of the novel AbsorbaSeal™ 5.6.7F vascular closure device.
- To assess the vascular remodeling and healing process following implantation in a swine model.
Main Methods:
- Eight heparinized swine underwent implantation of the AbsorbaSeal™ 5.6.7F VCD in the infrarenal aorta.
- Arteriotomies were assessed at 30, 60, 90, and 120 days for procedural safety, efficacy, and vascular remodeling.
- Histopathological evaluation was conducted by a blinded pathologist to assess inflammation, neointimal coverage, and device-related complications.
Main Results:
- 100% deployment success with rapid hemostasis (mean 21.5 seconds) achieved in all 24 implanted VCDs.
- No device-related complications or mortalities were observed throughout the study.
- Angiography and histology confirmed normal aortic appearance, complete neointimal coverage of the device components by 30 days, and minimal inflammation.
Conclusions:
- The AbsorbaSeal™ 5.6.7F VCD is a safe, effective, and secure device for achieving rapid hemostasis.
- The bioabsorbable components are fully integrated into the vessel wall within 30 days, demonstrating natural healing with minimal inflammation.
- This novel VCD shows promise for improving outcomes in percutaneous catheter-based procedures.
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.
