New Fully Absorbable Patch Based Large Hole Vascular Closure Device - Presented by Priv.-Doz. Dr. med. Michael Laule - Vivasure Medical

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

                  Implantation site                   „      Complete absorption
                                                      „      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