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 Charité University Hospital, Berlin, Germany

Potential conflicts of interest Speaker's name: Priv.-Doz. Dr. med. Michael Laule q I have the following potential conflicts of interest to report: Affiliation/Financial Relationship Company • • Grant/Research Support Vivasure Medical

Primary Drivers of Clinical Need Desired Approach: TAVR TEVAR „ Fully percutaneous EVAR „ Easy to use ECMO „ Safe and secure „ Fully bioabsorbable Challenge: „ Complications associated with currently available large hole closure devices

„ 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

Pre-clinical Histopathology: 30-180 days post implantation Implant Implant Implant Absorbed Encapsulated absorbing and extra-arterial Cross-section Cross-section Cross-section @ 32 days @ 91 days @ 180 days Porcine abdominal aorta – luminal surface 22F Arteriotomy Complete absorption „ Implantation site Implantation site undifferentiated „ from native arterial wall No granuloma/scaring „ Longitudinal histology @ No perivascular fibrosis „ 162 days

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%

Frontier III - Clinical Case Primary Procedure: TAVR with Edwards „ Sapien 3 Device 29mm Valve „ Closure Procedure: „ PerQseal Device „ 21F Closure

Frontier III - Results 62 subjects (70 closures) completed across 6 European centers „ Follow-up Subjects Procedures No. Discharge 62 TAVR 42 3 Month 59 EVAR 24 12 Month 42 TEVAR 4 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 „

NEXT STEPS Build clinical experience „ Indication expansion – (Frontier IV study) Post market – registries EU commercialisation „ Prepare for US IDE study „

Summary 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) Device provides a real option for fully percutaneous closure with „ the potential to reduce hospital costs and procedure times