VASCADE MVP Venous Vascular Closure System Receives CE Mark and Launches in Europe

Sep 09, 2023 07:30 CST Updated 07:30

Cardiva Medical

Medical Device R&D and Manufacturer

Medtronic

Medical Device Manufacturer

Haemonetics

A High-Tech Professional Company Specializing in Blood Processing Technology

Manual Compression (MC) is the traditional method for hemostasis at the puncture site after interventional procedures, but it is uncomfortable and time-consuming for both patients and clinicians, with a risk of hematoma formation. Depending on the access site, the size of the venotomy, and the degree of anticoagulation, MC may require 3-30 minutes along with a 2-8 hour period of compression fixation. The advent of Vascular Closure Devices (VCDs) has significantly reduced bed rest duration and postoperative care costs following arterial interventions. Many scholars believe that using specialized devices to close venous access sites holds similar potential to reduce bed rest time, facilitating early mobilization and discharge after catheterization procedures. However, currently, only one device, the MYNXGRIP VCD (Cardinal Health, Dublin, Ohio), has FDA approval for 7F venous closure indications, though reliable clinical data on its performance post-venous intervention remains lacking. The emergence of the VASCADE Vascular Closure System (Cardiva Medical, Inc., Santa Clara, California), which delivers a collagen patch to the outer surface of the vessel wall to achieve hemostasis, is now suitable for closure of 5F to 7F femoral arteriovenous access.

Comparison of VASCADE MVP Device with Traditional Methods

VASCADE MVP (Cardiva Medical, Santa Clara, California) Venous Vascular Closure System (VVCS) is a novel, investigational, disposable vascular closure device that achieves hemostasis by delivering an absorbable, extravascular collagen patch to the puncture site after sheath removal. This closure device can be used with sheaths up to 12F in size, including the Flexcath sheath (Medtronic, Minneapolis, Minnesota), for the Artic Front CryoAblation balloon (Medtronic) and the WATCHMAN Left Atrial Appendage Closure Device (Boston Scientific, Natick, Massachusetts). The device builds on the design of the VASCADE VCS (Cardiva Medical), which is already approved for use in closing arteriotomy sites ranging from 5F to 7F. Results from the randomized controlled U.S. pivotal RESPECT trial (n=420) demonstrated that following endovascular procedures performed via 6F or 7F access, the VASCADE VCS was safe and effective in closing femoral arterial access sites, showing no major vascular complications compared to manual compression (MC), fewer minor vascular complications, and shorter times to hemostasis, ambulation, and discharge.

AMULATE Trial

The study compared the efficacy and safety of the VASCADE MVP venous vascular closure system (VVCS) device (Cardiva Medical, Santa Clara, California) with manual compression (MC) for puncture site closure following electrophysiological procedures. Outcome measures included time to ambulation (TTA), total post-procedure time (TPPT), time to discharge eligibility (TTDe), time to hemostasis (TTH), 30-day major and minor complications, analgesic use, and patient-reported outcomes. A total of 204 patients were randomized to the closure device group (n=100; 369 puncture sites) or the MC group (n=104; 382 puncture sites). Baseline characteristics were similar between groups. Mean TTA, TPPT, TTDe, and TTH were significantly reduced in the closure device group (by 54%, 54%, 52%, and 55%, respectively; all p<0.0001). Opioid use was reduced by 58% (p=0.001). No major puncture site complications occurred. Minor complication rates were 1.0% in the closure device group and 2.4% in the MC group (p=0.45). Patient satisfaction with bed rest duration and comfort was 63% and 36% higher, respectively, in the closure device group (both p<0.0001). Overall satisfaction with bed rest pain was 25% higher in the closure device group (p=0.001), and 40% higher among patients with a history of ablation (p=0.002). The use of the closure device in cardiac ablation procedures significantly reduced TTA, TPPT, TTH, TTDe, and opioid use, with high patient satisfaction and no significant increase in complications.

AMULATE SDD Trial

AMULATE SDD Trial is a two-phase, multi-center, prospective, single-arm post-marketing study that collected data from patients discharged on the same day (SDD) of ablation, evaluating the outcomes and safety of using VASCADE MVP for venous closure in atrial fibrillation patients discharged on the same day. Professor Zayd A.Eldadah announced the relevant data of the study: 354 patients were included, with 151 (42.7%) undergoing treatment for paroxysmal atrial fibrillation and 203 (57.3%) receiving treatment for persistent atrial fibrillation. 323 patients (91.2%) completed SDD, of which 320 (99.1%) required no subsequent hospital intervention. No major access site complications were recorded. Patients discharged on the same day reported higher procedural satisfaction compared to those who stayed in the hospital. In this study, 99.7% of SDD patients did not require additional hospital intervention for access site-related complications during follow-up. SDD appears feasible and safe for eligible patients with paroxysmal or persistent atrial fibrillation after catheter ablation, with VASCADE MVP playing a significant role in venous access closure.

AMBULATE‐CAP Trial

Professor Amin AI‐Ahmad evaluated the feasibility of the VASCADE Venous Vascular Closure System (VVCS) through the AMBULATE‐CAP trial. Outcomes included hemostasis (all access sites), no major access site-related complications at 30 days, incidence of closure-related complications, and closure success rate. All 168 patients achieved successful hemostasis within 30 days without major access site-related complications. Among them, 39 patients (95.1%) received heparin treatment without access site-related complications, and 18 out of 18 patients (100%) were discharged on the same day with good perioperative management. VVCS effectively achieves hemostasis after interventional procedures with minimal associated complications.

Complications and Adverse Events Related to Access Site Closure Within 30 Days

MAUDE and FDA Monitoring Data

Professor Brian C.Case analyzed post-marketing surveillance data of the VASCADE vascular closure system from the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. A total of 201 reports were analyzed from post-marketing surveillance data between October 2013 and March 2020. Among the 201 reports involving major complications with the VASCADE device, 156 reports involved injuries (n=145) or deaths (n=11) associated with the device. In the 145 injury-related reports, bleeding was the most common adverse event (n=85), followed by pseudoaneurysm (n=29) and loss of pulse in the procedural limb (n=21). Among the device malfunction events (41 reports), operational failure was the most common cause. The analysis of the MAUDE database suggests that physicians should undergo training and education on the use of the VASCADE closure device before utilizing it.

On August 29, 2023, Haemonetics Corporation announced the launch of its VASCADE portfolio in Europe, with the VASCADE MVP venous vascular closure system being commercially available for the first time in Germany. The VASCADE system is specifically designed for "small-bore" femoral arteriovenous closure and is typically used in interventional cardiology and peripheral vascular procedures. The VASCADE MVP system is designed for "mid-bore" multi-access femoral arteriovenous closure and is generally used in electrophysiology procedures. Both closure devices have received CE certification under the European Union Medical Device Regulation (EU-MDR) and can be used in catheterization procedures involving single or dual-limb, single-access or multi-access patients.

VASCADE MVP Venous Vascular Closure System Introduction

VASCADE MVP (Cardiva Medical, Santa Clara, California) Venous Vascular Closure System (VVCS) is a novel, investigational, disposable vascular closure device that achieves the most stable state immediately after sheath removal by delivering an absorbable, extravascular collagen patch to the access site.

The main advantages of the VASCADE MVP venous vascular closure system are:

VASCADE is suitable for femoral artery and vein access puncture sites after diagnostic and/or interventional endovascular procedures. VASCADE comes in two sizes, 5 French or 6/7 French, covering most interventional procedure calibers.

Haemonetics

Haemonetics (NYSE: HAE) is a global healthcare company dedicated to providing customers with a full range of innovative medical products and solutions to help them improve patient care and reduce healthcare costs. In 2021, Haemonetics acquired Cardiva Medical, Inc. Cardiva Medical, Inc. is a private medical device company focused on revolutionizing vascular closure technology, benefiting patients, hospitals, and doctors in over 5.5 million coronary, peripheral vascular, and electrophysiology procedures annually in the U.S. that require puncture site closure.

Review and Compilation: Dr. Chen Xi, Attending Physician, Wuhan First Hospital

Editor: Oliver, Vascular Information

Copyright Statement: This platform aims to help healthcare professionals better understand the latest developments in relevant disease areas. The information published on this platform does not imply agreement with its descriptions or viewpoints; it is solely for providing more information. If there are any copyright issues, we kindly request the rights holders to contact us, and we will address them as soon as possible. The information is intended for healthcare professionals to stay informed and should not replace professional medical guidance in any way, nor should it be considered as medical advice. If such information is used for purposes other than staying informed, this platform and its authors assume no responsibility.Contact email for collaboration: vascular@edoctor.cn.