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Potential conflicts of interest
Speaker's name: Priv.-Doz. Dr. med. Michael Laule q I have the following potential conflicts of interest to report:
- Grant/Research Support
- Vivasure Medical
Affiliation/Financial Relationship Company
New Fully Absorbable Patch Based Large Hole Vascular Closure Device - - PowerPoint PPT Presentation
New Fully Absorbable Patch Based Large Hole Vascular Closure Device - - PowerPoint PPT Presentation
New Fully Absorbable Patch Based Large Hole Vascular Closure Device Presented by Priv.-Doz. Dr. med. Michael Laule Charit University Hospital, Berlin, Germany Potential conflicts of interest Speaker's name: Priv.-Doz. Dr. med. Michael Laule
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Primary Drivers of Clinical Need
Desired Approach:
Fully percutaneous Easy to use Safe and secure Fully bioabsorbable
Challenge:
Complications associated
with currently available large hole closure devices
EVAR
TEVAR
TAVR
ECMO
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Fully absorbable patch based Simple operation (OTW) Indicated 18F - 24F arteriotomies No suture, collagen or metal
components
Absorbed fully within 180 days in
animal model
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Cross-section @ 180 days Cross-section @ 32 days
Implant Encapsulated
Cross-section @ 91 days
Implant absorbing and extra-arterial Implant Absorbed
Pre-clinical Histopathology:
30-180 days post implantation
Longitudinal histology @ 162 days
Porcine abdominal aorta – luminal surface
Implantation site
22F Arteriotomy
Complete absorption
Implantation site undifferentiated from native arterial wall
No granuloma/scaring
No perivascular fibrosis
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Frontier III - Multi-centred European
Clinical Study
Aim of the Study: Assess the safety and clinical performance of a new fully percutaneous patch based synthetic absorbable Large Hole Closure Device (18-24F). Method:
50+ patients undergoing large bore femoral percutaneous access for TAVI, EVAR and TEVAR, prospective, non-randomized in 6 European centres
Assessment of puncture site with DUS/CT at discharge, 30 days, 90 days and 1 year
Primary endpoint: Incidence and severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE up to 3 months from implantation (as defined by VARC-2) is no worse than those associated with cut-down or suture based closure devices of 14.7%
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Frontier III - Clinical Case
Primary Procedure:
TAVR with Edwards Sapien 3 Device
29mm Valve Closure Procedure:
PerQseal Device 21F Closure
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Frontier III - Results
62 subjects (70 closures) completed across 6 European centers
Mix of devices and sheath sizes across procedures
No device related major vascular complications (VARC-2)
97% technical success
3 minor device related complications (haematoma, asymptomatic stenosis and pseudoaneurysm
No late minor or major device related vascular complications
No clinically significant changes on ultrasound or CT-Angiogram
Follow-up Subjects Discharge 62 3 Month 59 12 Month 42 Procedures No. TAVR 42 EVAR 24 TEVAR 4
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NEXT STEPS
Build clinical experience
–
Indication expansion (Frontier IV study)
–
Post market registries
EU commercialisation
Prepare for US IDE study
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Easy to use device with low learning curve
Patch-based, fully bioabsorbable implant
Requires no pre-procedure steps
Has clinically demonstrated its safety and effectiveness with excellent outcomes from discharge through 1, 3 and 12 month follow-up (120 patients in Frontier I, II and III)