next generation tavr technologies...369 353 342 330 319 296 portico valve commercial valve 0 30 90...

Alexandre Abizaid, MD, PhD, FACC

Instituto Dante Pazzanese de Cardiologia

Sao Paulo, Brazil

Next Generation TAVR Technologies

Conflict of Interest

Proctor for Boston Scientific and Edwards Life Science

New TAVI systems: Why do we need new valves?

Before… …Today.

Edwards

Centera

Braile Biom.

Inovare

MyVal

New Generation TAVR Devices:

▪ Sapien 3 Ultra (Edwards)

▪ Evolut R (Medtronic)

▪ Portico (Abbott)

▪ Lotus (Boston Scientific)

▪ Acurate Neo 2 (Boston Scientific)

▪ Jena Valve (JVT)

▪ Allegra (NVT)

▪ MyValve (Meril Life Science)

▪ Leaflex (Pi Cardia)



▪ Evolute R (Medtronic)



▪ Symetis Accurate (Boston Scientific)


▪ Allegra (NVT)



Valve Outer Skirt Comparison

SAPIEN 3 Valve SAPIEN 3 Ultra Valve

Same biocompatible PET material

Flat woven fabric Textured fabric

Sheath Size

14F 20 mm 14F

The Edwards SAPIEN 3 Ultra System: Axela Sheath

7

Transient expansion and active contraction

Next-generation seamless expandable

sheath design

14F 23 mm 14F

14F 26 mm 14F

14F 29 mm 14F

Valve Size



▪ Evolut R (Medtronic)





▪ Nautilus (NVT)



CoreValve Evolut Design Goals

True Anatomical Fit:

• Tailored height and shape

• Conformability and sealing with

optimized radial force and

interference across annular ranges

• Coaptation in non-circular anatomy

with supra-annular valve position

AOA®

Anti-Mineralization Treatment:

• Reduce both early and late valvular

calcificationR








▪ Nautilus (NVT)



369 Assigned Commercial valve381 Assigned Portico valve

375 Treatment Initiated

361 Implanted 371 Implanted

30 Day FU: 97.2%

1 Year FU: 98.1%

30 Day FU: 97.5%

1 Year FU: 97.4%

Pivotal RCT: Patient Flow

750 Randomized (ITT)

ITT= Intention-to-Treat population

3 Withdrew informed consent

2 Died before procedure

1 Did not meet eligibility criteria

1 Randomized after subject expired

3 Did not meet eligibility criteria

2 Withdrew informed consent

1 Investigator decision

2 Died during implant procedure

1 Converted to SAVR

1 Unable to gain vascular access

1 Converted to SAVR

362 Treatment Initiated

750 randomized subjects enrolled from 52 sites in US and AUS between May 2014 to Oct 2017

1% 7% 57% 4% 25% 6%

2.9%

Pivotal RCT: Primary Effectiveness Components

381 360 338 333 320 301369 356 347 335 324 300

Portico valve

Commercial valve

0 30 90 180 270 365

Days from Randomization

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

All-

Cau

se M

ort

alit

y at

1 Y

ear

14.3%

12.0%

Mean difference 2.3%

Log-rank p = 0.30

All-Cause Mortality

381 355 335 330 319 300369 353 342 330 319 296

Portico valve

Commercial valve

0 30 90 180 270 365

Days from Randomization

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Dis

ablin

g S

tro

ke a

t 1

Yea

r

Disabling Stroke

Mean difference -1.3%

Log-rank p = 0.30

# At Risk# At Risk

1.6%

2.9%

Pivotal RCT: Primary Safety Components

Clinical Endpoint at 30 DaysPortico valve

N=381

Commercial valve

N=369

All-Cause Mortality 3.5% (13) 1.9% (7)

Disabling Stroke 1.6% (6) 1.1% (4)

Life Threatening Bleeding Requiring Transfusion 4.5% (17) 3.6% (13)

Acute Kidney Injury Requiring Dialysis 1.1% (4) 0.8% (3)

Major Vascular Complications 9.6% (36) 6.3% (23)

Difference in safety profiles driven by higher N of major vascular complications in Portico valve group (+3.3%).

Data presented as Kaplan-Meier Estimate Event Rates % (n of subjects with event)

• Moderate or greater PVL is higher in Portico valve group

• 63% of all commercial valves implanted had a PVL reducing feature

Pivotal RCT: Paravalvular Leak

Portico valve (n=381) Commercial valve (n=369)

0%

20%

40%

60%

80%

100%99.6

93.7 92.5

97.9 98.5

37.7

45.5

58.1 59.2

Per

cent

of R

ando

miz

ed S

ubje

cts

Mild

Moderate

Severe

None/Trace

30 Days

n=33412 Months

n=266

30 Days

n=329

12 Months

n=262

99.7

None/Trace

Mild

Moderate

Severe








▪ Nautilus (NVT)



See GlossarySH-31314-AD Nov 2012 Slide 17 of 39

Lotus ValveDesigned for Controlled Deployment

Pre-loaded valve, attached to a18F

delivery system

23mm & 27mm Diameter

Accurate Placement &

Repositionable

True Retrievability

Adaptive seal designed to minimize

paravalvular leak

Deploy Retrieve

Release

iSleeve Expandable Introducer



▪ Centera (Edwards)




▪ Accurate Neo 2 (Boston Scientific)


▪ Nautilus (NVT)


ACURATE TF Aortic Bioprosthesis

LOWER CROWN

Minimal LV protrusion

Low risk of conduction

defects

UPPER CROWN

Supra-annular anchoring Stable positioning

Tactile feedback

STABILIZATION ARCHES

Flexible

Self-aligning

SELF-EXPANDING NITINOL

Conforms to native anatomy

3 sizes: 21mm to 27mmPERICARDIAL LEAFLETS

Porcine pericardium

Lower profile

PERICARDIAL SKIRT

Inner & outer skirt acts as

seal to prevent PVL

ACURATE TF 3-Step Implantation

Initial Alignment

1. Open upper crown & gentle pressure forward

2. Open stabilization arches

3. Open lower crown for full deployment

ACURATE TF FIM Case

Upper Crown

ACURATE TF FIM Case

Stabilization

arches

ACURATE TF FIM Case

Lower Crown

ACURATE TF FIM case

Primary Endpoint - Per Protocol Analyses

Non-inferiorityNon-inferiority margin = 7.7%

-2.0% 0% 2.0% 7.0% 12.0% Risk difference (M-H)

Upper-limit one-sided 95%-CI:12.1%

P value for non-inferiority: 0.39

Superiority

ACURATE Aortic Valve Evolution

Information not intended for use in France. CE mark received 2014. Information for the ACURATE Valve System is for use in

countries with applicable product registrations. Indications, contraindications, warnings and instructions for use can be found in the

product labeling supplied with each device. The ACURATE neo2 is an investigational device only. Not approved for sale or use.

2nd Generation

ACURATE neo

TF (CE 2014) & TA (CE 2017)

3rd Generation

ACURATE neo2









▪ Allegra (NVT)


© JenaValve™ Technology 2017 | confidential

JenaValve Everdur THV

THV CUSP

• PORCINE PERICARDIUM

• (3) LEAFLETS SEWN ONTO

FRAME

NITINOL FRAME

• SELF-EXPANDING

• LOW OVERALL HEIGHT

• OPEN CELL DESIGN

SEALING RING

• (24) RHOMBOID ELEMENTS

LOCATORS

• TISSUE-COVERED

• RADIOPAQUE MARKER

INTERMEDIATE STRUTS

• PROXIMAL END ATTACHED ONTO DELIVERY CATHETER

THV

• PORCINE PERICARDIAL TISSUE

• JASMINE™ (ANTI CALCIFICATION)

TREATMENT

© JenaValve™ Technology 2017 | confidential

Procedure Steps

1. Setting

Locators align with native cusps to mimic anatomy

✓ Inhibits coronary obstruction

✓ Better durability

✓ Enhanced hemodynamics

2. Seating

Locators ensure minimal protrusion into LVOT

✓ Less arrhythmia

✓ Low rate of permanent

pacemaker implantation

3. Sealing

Locators clip onto native leaflets forming a natural seal

✓ Less PVL

✓ Needs no calcium to anchor

✓ Can treat pure AR









▪ Allegra (NVT)


▪ Usable length 1150 mm, 18 Fr Cartridge / 15 Fr Catheter, Gradual

decrease in stiffness

▪ Squeeze-to-Release mechanism allows for stepwise and controlled

implantation avoiding rotation; 2 mm stepwise deployment

▪ PermaFlow deployment – Constant flow during implantation

▪ Integrated sheath for a stable implantation

▪ Radiopaque marker rings provide clear orientation during implantation

▪ Optimized catheter tip design enables an atraumatic implantation

▪ Safety locker mechanism

guarantees a safe release

▪ Radiopaque marker rings enable precise positioning during implantation








▪ Allegra (NVT)



Hyb

rid

Ho

ney

com

b C

ell

Des

ign

Co

nce

pt

Open cells on upper half to ensure un-jailing of coronary ostia

Closed cells on lower half for high radial strength

External PET buffing to minimize para-valvular leaks

Bovine pericardium Tri-leaflet valve

Internal PET sealing cuff for lower profile & puncture resistance

Nickel Cobalt alloy frame for high radial strength & RO

≈ 5

3%

Ø – 20 mm, 23 mm, 26 mm, 29 mm#

21.5 mm 24.5 mm 27.5 mm 32 mm new*

≈ 4

7%

Fram

e h

eigh

t 1

7-2

0 m

m

MyVal – Balloon Expandable THVDesign Philosophy

MyVal THV has been indigenously developed by Meril Life Sciences, Vapi, India

# - Sizes available now* - Sizes coming soon

Atraumatic, 14 Fr Distal Entry ProfileAllows for percutaneous access

Python –Expandable Introducer Sheath

Sheath expands momentarily (like a python swallowing prey)

to allow passage of THV crimped balloon catheter

24 Fr Proximal Entry PortAllows for smooth valve loading

One-way hemostatic valve

14 Fr & 16 Fr versions

Python – Expandable Introducer Sheath has been indigenously developed by Meril Life Sciences Pvt. Ltd.

MyVal 29 mm Deployment

Precise placement & deployment Final – Orthotopic Deployment

Clinical case, images and videos courtesy Dr. Samin Sharma & Dr. Ravinder Singh Rao, EHCC, Jaipur, India








▪ Allegra (NVT)



The Leaflex Performer

Non-implant based treatment for AS

Principle Segmentation of calcium bridges (Scoring)

Effect Increased leaflet mobility, resulting in substantial improvement in valve area

Goal To provide a short and simplestandalone procedurealongside TAVI

The Leaflex Procedure

next generation tavr technologies...369 353 342 330 319 296 portico valve commercial valve 0 30 90...

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