new fully absorbable patch based large hole vascular
play

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

0 downloads 3 Views 1,73 MB Size Report
  1. New Fully Absorbable Patch Based Large Hole Vascular Closure Device Presented by Priv.-Doz. Dr. med. Michael Laule Charité University Hospital, Berlin, Germany

  2. 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

  3. 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

  4. „ 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

  5. 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

  6. 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%

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

  8. 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 „

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

  10. 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

Recommend Documents


large hole vascular closure device
Large Hole Vascular Closure Device

New Fully Absorbable Patch Based Large Hole Vascular Closure Device Jeffrey

interactive visualization and on demand processing of
Interactive Visualization and On-Demand

Interactive Visualization and On-Demand Processing of Large Volume Data: A

a fully a fu lly gpu gpu based based ou out of of
A Fully A Fu lly GPU GPU-Based

ence ce eren Confer A Fully A Fu lly GPU GPU-Based Based Ou Out-Of

disclosures
Disclosures Co-editor, Global

4/17/2018 Global Vascular Guideline on the Management of Chronic Limb

pat patch ch based based ei eigen en fac ace e isomap omap
Pat Patch ch-based based Ei Eigen

Fac acial ial Ex Expression ression Det etecti ection on using ng Pat

academic vs clinically based vascular surgery fellowships
Academic vs. Clinically -based Vascular

Academic vs. Clinically -based Vascular Surgery Fellowships John E. Rectenwald

soft hair enhanced entanglement beyond page curves in
Soft-Hair Enhanced Entanglement Beyond

Soft-Hair Enhanced Entanglement Beyond Page Curves in Black-Hole Evaporation

optimizing the performance of
Optimizing The Performance Of None

4/7/2017 Disclosure Optimizing The Performance Of None Your Vascular Lab

academic based vascular surgery fellowships
Academic-Based Vascular Surgery

Vascular Annual Meeting General Surgery Resident Breakfast Program May 30,

an analysis of patch plausibility and correctness of
An Analysis of Patch Plausibility

An Analysis of Patch Plausibility and Correctness of Generate-And-

perspectives on pocus handout from stfm conference
Perspectives on POCUS - Handout from

Perspectives on POCUS - Handout from STFM Conference Presentation 4/2019 A

fsi simulation of pulsatile blood flow in aortic arch
FSI Simulation of Pulsatile Blood Flow

FSI Simulation of Pulsatile Blood Flow in Aortic Arch (coupling Abaqus and

connie lorette phd crna intraoperative monitoring ase sca
Connie Lorette, PhD, CRNA

Connie Lorette, PhD, CRNA Intraoperative monitoring ASE/SCA assess 20 view

30 05 11
30-05-11 Clinical outcome after

30-05-11 Clinical outcome after pre-incision Aim Study assessment of

sub aortic stenosis in england 1997 2015 reoperation
Sub-aortic stenosis in England 1997

Sub-aortic stenosis in England 1997 2015: Reoperation rates and risk factors

hello my name is ka e girgulis and i am a medical student
Hello, my name is Ka.e Girgulis

Hello, my name is Ka.e Girgulis and I am a medical student at the

inoperable patients with severe aortic
Inoperable Patients With Severe

Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) in

the heart the heart
THE HEART THE HEART MEDIASTINUM

THE HEART THE HEART MEDIASTINUM PERICARDIUM HEART THE HEART THE

improving the efficiency of manual ground truth labeling
Improving the Efficiency of Manual

Improving the Efficiency of Manual Ground Truth Labeling Using Automated

late presentation of turner syndrome and its
Late Presentation of Turner Syndrome

Late Presentation of Turner Syndrome and Its Complications Huzairi Sani 1 ,

tirone david v s mod v sarr for
Tirone David-V S mod V-SARR for

Tirone David-V S mod V-SARR for Bicuspid Aortic Valve (BAV) Aortopathy and AR

ecmo in the emergency department
ECMO. In the Emergency Department

ECMO. In the Emergency Department John C. Greenwood, MD Department of