Meril - TAVI

Meril is a prominent Indian Med-Tech company based in Vapi, India & is present in more than 100 countries.

1. MLS|MVL|PPT|V1.0|27Oct2018|

2. Meril Life Sciences
•Meril is a prominent Indian Med-Tech company based in Vapi, India
& is present in > 100 countries.
•Meril R&D has indigenously developed >100 clinically relevant,
state-of-the-art and best in-class devices/technologies ranging broad
operational canvas viz –
–Vascular Interventions | Orthopedics | Endo Surgery | In-vitro Diagnostics.
•Meril Academy is committed to training and education of health care
professionals

Meril Park Meril Academy

3. Meril CV Portfolio
•Respected for its eclectic CardioVascular portfolio, the company has to its
credit well known key technologies – DES, BRS, DCB, Occluders, TAVI,
SAVR, IABP…
•Cardiovascular
•Peripheral vascular
•Neurovascular
•Structural Heart Disease
•Congestive Heart Failure

4. Aortic Stenosis in the Elderly
Disease Prevalence and Number of Candidates
for Transcatheter Aortic Valve Replacement:
A Meta-Analysis and Modeling Study
J Am Coll Cardiol. 2013;62(11):1002-1012. doi:10.1016/j.jacc.2013.05.015
General
Population
>75 years
Severe AS
3.4% (1.1-
5.7)
Asymptomatic No TAVR
I. Symptomatic
75.6% (65.8-
85.4)
II. Not treated with
SAVR, potentially
treatable with TAVR
40.5% (35.8-45.1)
IV. Treated with
SAVR
59.5% (54.9-64.2)
III. Treated with TAVR
40.3% (33.8-46.7)
28.7% (22.8-34.6) all
studies
TAVR
Not treated with
TAVR
Medical
Management
V. Patients with
STS-PROM>10%
5.2% (4.9-5.4)
VI. TAVR
80%
SAVR 20%
Patients with STS-
PROM 5-10%
15.8% (15.4-16.2)
Patients with STS-
PROM <5%
79.1% (78.6-79.5)

5. TAVR Underutilization
0
50
100
150
200
250
2015 Country TAVR Penetration
Total TAVR Cases / Millions of Inhabitants
YTD < 600 TAVR Cases done in India
The Relentless Journey of TAVR to Lower-Risk Patients: Are we there yet? Dr. Martin Leon, TVT 2016. tctmd.com
Source: Eurostat, US Census Bureau, Industry estimates
TAVR Cases / Mio Population

6. Key Requirements in Developing TAVI-
•Establishment of a nation wide training & education programs
•Collaboration amongst TAVI enthusiasts – Heart Team
–Interventional Cardiologists
–Cardiovascular Thoracic Surgeons
–Echocardiography
–CV Anesthetist
–Hospital Paramedic Team
•Continuous R&D and clinical research to bring affordable TAVI to a
large needy population

Indian Valve Disease Statistics
Large Unmet Clinical Need
Potential TAVI Tx
population
(40.5%)
281,073
patients
Demographics Numbers
Indian population 1.35 bio
Population > 75
years (2%)
27 mio
Incidence of
severe AS (3.4%)
918,000
patients
Symptomatic AS
(75.6%)
694,008
patients
Potential SAVR Tx
population
(59.5%)
412,935
patients
+ Industry

7. Hybrid Honeycomb Cell
Design Concept

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
≈ 53%

Ø – 20 mm, 23 mm, 26 mm, 29 mm
#
21.5 mm 24.5 mm 27.5 mm 32 mm new*
≈ 47%

Frame height 17
-
20 mm

MyVal – Balloon Expandable THV
Design Philosophy
MyVal THV has been indigenously developed by Meril Life Sciences, Vapi, India
# - Sizes available now
* - Sizes coming soon

8. Commisure

Commisure

Open Cells

53%

Close Cells
47%

MyVal – Precise Deployment
Ventricular End
Aortic End
Upon Crimping-
•V-shaped hinges on hexagonal frame fold, generating the
dense bands on fluoroscopy
•Vertical connectors | give rise to light bands
•Alternating V-folds & vertical connectors give MyVal a
unique appearance on fluoro for ease of positioning
1
st
Dense Band
2
nd
Dense Band
1
st
Light Band
2
nd
Light Band
3
rd
Dense Band
3
rd
Light Band
4
th
Dense Band

9. 2
nd
Dense Row
Landing Zone
Annular Plane
Distal End
Towards Ventricle
Schematic of Crimped MyVal on Navigator Balloon
Prox. balloon marker
Mid balloon marker
1
st
Dense Row
2
nd
Dense Row
1
st
Light Band
2
nd
Light Band
Dist. balloon marker
Upon Crimping-
•Alternating V-folds & vertical
connectors give MyVal a unique
appearance on fluoro for ease
of positioning
MyVal – Precision Placement Technique

10. MyVal Size Matrix
& Technical Specs.


Area 313 mm
2





20 mm
Area 414 mm
2





23 mm
Area 529 mm
2





26 mm
Area 658 mm
2





29 mm
Perimeter 62.83 mm 72.26 mm 81.68 mm 91.11 mm
# of Crowns 9 12 12 12
Python Expandable
Introducer Sheath
14 Fr 14 Fr 14 Fr 16 Fr
Native annulus area 273 – 345 mm
2
338 – 430 mm
2
430 – 546 mm
2
540 – 683 mm
2
Area-derived
diameter
18.6 – 21 mm 20.7 – 23.4 mm 23.4 – 26.4 mm 26.2 – 29.5 mm
Native annulus size
by TEE
16 – 19 mm 18 – 22 mm 21 – 25 mm 24 – 28 mm
17.35 mm

17.85 mm

18.85 mm

20.35 mm

MyVal – Size Matrix

11. MyVal Sizing – Coronary Height Cut-Offs
MyVal Sizes 20 mm 23 mm 26 mm 29 mm
MyVal Total
Height
17.35 mm 17.85 mm 18.85 mm 20.35 mm
MyVal Open Cells
53%
9.19 mm 9.46 mm 9.99 mm 10.87 mm
MyVal Close Cells
47%

8.16 mm 8.39 mm 8.86 mm 9.48 mm
MyVal Infra-
annular height
3.05mm 2.85 mm 3.05 mm 3.35 mm
Supra-annular
height of close
cells
5.11 mm 5.54 mm 5.81 mm 6.13 mm
Minimum
Approved
Coronary Height
10 mm 10 mm 10 mm 10 mm
•Check Sinus of Valsalva lengths for each cusp
•Protect coronary if height ≤ 15mm with DES
Open Cells

53%

Close Cells
47%

6mm
Largest circumscribable
diameter in Open Cell

12. Delivering TAVI Made Easy
•MyVal THV device is recommended to be crimped directly across the balloon
•MyVal THV direct crimping on the balloon makes TAVI delivery simple,
intuitive and eliminates unwarranted procedural steps.
•The crimped valve with delivery system is then loaded through 14/16Fr
Python – Expandable Sheath
•Navigator balloon delivery system has a set of proximal and distal Stoppers
which ensure that valve crimping is precise and snug.
•Visual confirmation of crimped valve can be had before entering the sheath
to avoid any crimping errors/defects.
•The Stoppers prevent inadvertent migration of the valve & ensure there is no
risk of valve dislodgement (embolization) during entry through the sheath or
while negotiating the loaded delivery system across the aorta.

13. Navigator THV Delivery System
Usable catheter length 120 cm
0.035” guide wire
20
mm
23 mm 26 mm 29 mm
6 atm
12 mL

18 mL

23 mL

30 mL

Proximal Shaft with Rotatory
Handle for Hi-Flexion
14F
30 mm
Navigator – THV Delivery System has been indigenously developed by Meril Life Sciences Pvt. Ltd.
Navigator Balloon Ø
Balloon Length
Balloon RBP
Volume of 75:25
Saline:Contrast to
achieve stated balloon
diameter

14. Navigator – Distal End Balloon Format
30mm
Balloon length all Ø
Crimped Valve
PET Skirting to
be towards
distal end
during TAVR
Balloon RO markers
Proximal Mid Distal
Navigator w/o MyVal
Navigator with MyVal
Distal nose
cone with soft,
atraumatic tip
Proximal Stopper Distal Stopper
Navigator Inflated Balloon
Proximal Stopper Distal Stopper
•Unique construction of distal balloon
assembly creates a central shallow zone
which ensures snug fit of MyVal-THV

15. Navigator Balloon Expansion

•Navigator balloon with dual expansion ports at each end ensures rapid, simultaneous,
controlled expansion (dog-boning) of distal and proximal ends
•This typical dog bone pattern of inflation steadies the Valve during expansion phase,
ensure its precision annular position and deployment without any risk of valve
migration or embolization
•Rapid balloon inflation using a inflation device is possible with controlled palm thrust
•Rapid balloon deflation 3-5 sec ensures procedure safety and compliance

16. Navigator – Proximal Assembly
J

Un-deflected Catheter
position (straight)
Clock-wise rotation to
achieve distal end flexion
Maximum deflection
catheter position
Balloon inflation
port
0.035” Guide wire
exit port
Proximal Shaft with Rotatory
Handle for Hi-Flexion
Note the horizontal band – migration from straight to J symbol denoting distal flexion
Caution : Always remember to fully un-flex the Navigator system while withdrawing

17. Navigator – Deep-Flexion
Horizontal annulus
Turn proximal flexion knob & advance system
Deep flexion is possible
Caution : Always remember to fully un-flex the Navigator system while withdrawing

18. Mammoth OTW Balloon
0.035” guide wire compatibility
Soft, atraumatic
nose cone
2 RO markers
exclusive of balloon
length
Anti-slip surface for
controlled expansion
130 cm usable shaft
length
9 Fr
Over-the-wire system
Mammoth – Balloon Catheter has been indigenously developed by Meril Life Sciences Pvt. Ltd.
Mammoth Balloon Ø 16
mm
20
mm
23
mm
25
mm
Balloon length  40 mm 
Balloon RBP  6 atm 
Volume of 75:25
saline:contrast to achieve
stated diameter
12
mL
18
mL
23
mL
30
mL

19. Atraumatic, 14 Fr Distal Entry Profile
Allows for percutaneous access
Python –
14Fr Expandable Introducer Sheath
Sheath expands momentarily (like a python swallowing prey)
to allow passage of THV crimped balloon catheter
Proximal Entry Port
Allows for smooth valve loading
One-way
hemostatic
valve
14 Fr Profile for all Myval diameters
Ø 20, 23, 26, 29 mm
RO distal tip
A separate loading tube ensures
temporary opening of sheath valve
allowing smooth passage of crimped
Myval-THV
Seamless transition
from dilator to distal tip

20. Ilio-Femoral Sizing Requirements
MyVal - THV Ø 20mm Ø 23mm Ø 26mm Ø 29mm
Sheath Size (ID) 22Fr 22Fr 22Fr 24Fr
Sheath OD
26.4Fr / 8.8
mm
26.4Fr / 8.8
mm
26.4Fr / 8.8
mm
28.5Fr / 9.5
mm
Minimum Vessel Diameter Measured on CT Required to Prevent Vascular Injury
Common Femoral 8.5 mm 8.5 mm 8.5 mm 9.0 mm
External Iliac > 8.5 mm > 8.5 mm > 8.5 mm > 9.0 mm
Common Iliac 9.0 mm 9.0 mm 9.0 mm 9.5 mm
•Recommended sheath compatibility when Python 14Fr expandable sheath is not used

21. MyVal + Navigator Preparation
A. Flushing guide wire lumen with saline B. Partial crimping of the valve
C. Initial crimping of valve on balloon D. Final crimping of the valve
CrocoDial – Heart Valve Crimping Tool has been indigenously developed by Meril Life Sciences Pvt. Ltd.

22. MyVal Performance Testing
* Suture retention test is performed as per ISO 7198 Cardiovascular Implants – Tubular Vascular Prosthesis
** Durability tests is performed as per ISO-5480-3 test guidelines
MyVal bench performance with good leaflet coaptation
•MyVal – THV system has been successfully
tested for its functionality in robust &
aggressive in-vitro bench models as
prescribed by ISO – 5480-3 tests.
•Effective Orifice Area (EOA)
–Pre-Accelerated Wear Test (AWT) for the
valves ranged between 2.63-2.99 cm
2
.
–Post-AWT EOAs for the valves range
between 1.90 – 2.14 cm
2

23. MyVal – Pre-clinical Work
•In animal models, MyVal has been extensively studied in
sheep-
–Transcatheter deployment in orthotopic position via trans-iliac
approach
–Transcatheter deployment in Huffnagel’s position
–Surgical deployment in Mitral position
–Transcatheter deployment in orthotopic position via common
carotid approach

24. Acute deployment of Myval

– TAVR system is feasible and convenient in Ovine
Huffnagel’s aortic position.
Pictures Courtesy Accel Labs, Montreal, Canada
MyVal – PreClinical
Huffnagel’s Position

25. Myval

being deployed at native mitral
position using surgical techniques
•In native mitral position, the acute deployment of MyVal

is successful using surgical
techniques. Post deployment, the TAV behavior is as expected and there is no sign of
excessive regurgitation or paravalvular leak.
Acute deployment of Myval – TAVR system is safe and convenient with predictable
valve functionality in ovine mitral valve position using CPB surgical techniques.
Picture courtsey AHP, Katowice, Poland
MyVal – Pre-Clinical
Surgical Implantation in Mitral Position

26. MyVal in Orthotopic Position via
Ascending Aorta External Banding
•Step 1 – surgically fix an
external annulus ring at
ascending aorta above STJ in
ovine model
•Allow the animals to heal for 3-
4 weeks
•Step 2 – percutaneously
implant MyVal via left carotid
approach across the native
valve
•Study biofunctionality of MyVal
in orthotopic position
Video courtsey AHP, Katowice, Poland

27. Mechanical Surgical Tissue TAVI PMVI

Valvuloplasty

Pre-Clin Clinical Commercial Pre-Clin Commercial
Low

Medium

Premium

Technology Segments

SHD Portfolio – Beyond MyVal THV
3D-Echo, Skirball Lab, NY. * Currently in pre-clinical stage.
Occluders

Commercial

28. Let’s TAVI…