Moving Towards Biomimicry

BioMime
Morph
SES

BioMime
Aura
SES

BioMime
SES

NexGen
Co-Cr
BioMime Morph
Sirolimus Eluting Tapered Coronary Stent System
 Identifying Unmet Clinical Need

Research premise for BioMime Morph –

Sirolimus Eluting Tapered Coronary Stent System is
based on two primary observations from
routine PCIs-
1. Anatomical shape of vessels
2. Procedural concerns associated with
stenting of long diffused lesions
 Anatomical Shape of Vessels

• Right coronaries are generally tubular & non-

tapering vessels

• Left coronaries generally give off branches &

taper
– The vessels usually tend to taper to the tune of
10-15% per 30mm of vessel length
 Procedural Concerns
• Procedural concerns with long diffused lesion stenting
– Long diffused lesions need to be treated with multiple stents
– Multiple stents need to be overlapped
– Concerns with overlapping DES-
• Vessel rigidity – make the vessel rigid due to excess metal
• Fracture – are more prone to fracture due to rigidity
• Restenosis – cause higher vascular injury leading to restenosis
• Drug overdose – have twice the dose leading to delayed healing
Delayed healing

• Polymer inflammation – have twice the polymer dose leading to

polymer inflammation
• Aneurysm – excessive drug dose may lead to aneurysms
• Side branch jailing – excess un-organized metal may jail important side
branches
• Over radiation – multiple stenting procedure take longer time and expose the
operator to over radiation
• Contrast media – multiple stenting procedure involves more contrast media
• Cost – multiple DES cost more
Identifying the Unmet Clinical Need
Anatomical PCI Procedural

Concerns with Multiple

• Right coronaries are Stenting of Long Lesions
generally tubular, • Vessel rigidity

Delayed healing
non-tapering • Fracture
• Restenosis
• Aneurysm
• Drug overdose
• Polymer inflammation
• Left coronaries
• Side branch jailing
usually taper after
• Over radiation
each branch
• Excess contrast
• Cost
 Limitations of Current Treatment

• In the present scenario, to treat lesions

>48mm one is compelled to use two or more
stents
• Anatomical mismatch between currently
available cylindrical stents with natural taper
of coronary arteries
– Higher distal diameter has a propensity to cause
distal vessel dissection
 Limitations of Current Treatment

Long diffused lesion of LAD Artery Cylindrical artery at the stented site
requiring 2 overlapping stents and an abrupt tape distal to stent
 The Solution – BioMime Morph
BioMime Morph System Components
• The Stent – Classical BioMime hybrid design which has an
intelligent mix of closed cells at the edges and open cells
articulating along the length of stent
• The Drug – Clinically established anti-proliferative – Sirolimus
(dose 1.25μg/mm2)
• The Polymer – Biocompatible, biodegradable co-polymer
combination of PLLA+PLGA – BioPoly
• The Delivery System – A newly designed tapered PTCA
Balloon Catheter with half size diameter tapers & a reinforced
shaft system for enhanced flexibility & effortless deliverability
D1 D2
D1 > D2 Difference of 0.5 mm
 Advantage BioMime Morph

• Provide anatomical correct treatment

– Tapered stent for tapered vessels such as LAD / LCX
– Regular stent for non-tapered vessel such RCA
• A single long stent to cover lesions upto 56mm
– Avoid overlapping DES
• Better vessel wall coverage due to uniform stent
design
– High conformability & no mallaposed struts
– Reduced blood flow perturbances & shear stress
 Advantage BioMime Morph
• Optimal metal to artery ratio
– Uniform drug-polymer distribution for predictable healing and to
minimise neo-intimal hyperplasia (restensosis)
– Reduced propensity for aneurysm
• Robust design elements to ensure high stent flexibility
without any risk of fractures
• No geographical miss due to precision in stent dimensions
• Procedural convenience of using a single stent
– Reduced procedural time
– Less exposure to radial (benefits operator)
– Reduced use of contrast media (benefits patient)
– Lower costs than multiple DES
 Stent Architecture
• Cobalt chromium (L605) platform with 65µm strut thickness.
• Hybrid cell design comprising of an intelligent mix of open and
close cells resulting in excellent radial strength with a high
flexibility.
• Unique strut width variability that ensure a <3% recoil and 0.29%
foreshortening
• Special electro-polishing technique eliminates surface nickel oxides
SEM image of crimped BioMime Morph at 50x

Closed cell at edges Open cell in mid - segment

Hybrid design
 High Radial Strength
• BioMime Morph demonstrates comparable radial strength with
mean collapse pressures of 1.1bar which is on the higher side
amongst 14 predicate devices tested

Red dot signifies BioMime Morph mean values

 High Radial Strength
• Competitive radial strength combined with high
flexibility with ultra-low strut thickness
1.6
1.4
Radial Strength (Bars)

65µ 65µ 65µ 81µ 80µ 90µ

1.2
1
Hybrid design

Hybrid design

0.8

Open Cells
Open Cells

Open Cells
Open Cells

0.6
0.4
0.2
0
BioMime BioMime Coroflex Vision Prokinetic Driver
Morph blue
 Choice for Co-Cr L605 & RO
• Stronger than S/S – allows for mfg of
thinner struts while maintaining radial
strength
• Denser than S/S – Higher density allows for
thinner struts with good RO
• More MRI compatibility – Since Fe content
is negligible (<1%), Co-Cr is non-
ferromagnetic as compared to S/S Excellent Radiopacity

45% stronger than S/S

 Recoil & Foreshortening
• Bench testing demonstrates a <3% recoil and 0.29%
foreshortening
• Closed-cells on the edges lend their radial strength to the
entire scaffold
• Strut-width variability across the design geometry ensure
retention of radial strength

Variable width

Y-connector S-link Mirror polish

 Bench Performance
Pushability Trackability Dislodgment Force
• BioMime Morph • BioMime Morph • BioMime Morph
demonstrates lower demonstrates lowest demonstrates
tracking force (mean tracking force (mean highest mean stent
ultimate force value ultimate force of 2.89N) dislodgement force
0.73N) during amongst 7 predicates of 7.5N in
pushability test in during benching testing comparison to 12
comparison to 17 for trackability predicates.
predicate devices
during the bench test

Red dot signifies BioMime Morph mean values

 Excellent Side Branch Access

The area of the largest circle

circumscribable in the cell of the stent
expanded to the nominal diameter:
Tc = 0.71 mm2

The expanded BIOMIME Morph 3.0-2.5 x 30 mm

stent after side branch expansion
Expanded cell perimeter that ensures side branch access: KSBA = 11.29 mm
Expanded cell area that ensures side branch access: TSBA = 8.00 mm2
 Unique Balloon Construction
• BioMime Morph maintains a highly controlled balloon
overhang of <0.5mm with short tapered shoulders which have
a propensity to minimize balloon related arterial injury

Note the narrow

balloon shoulders
which assist in
minimizing balloon
related vessel
injury Complete expansion
 Right Drug – Sirolimus & Loading

• Sirolimus is an ideal choice considering that it acts on the

common final pathway of cell division cycle without exceptional
risk of necrosis induction
• BioMime Morph has 1.25µgm/mm2 of Sirolimus loading on stent

Drug Loading (µg)

Stent
Stent Daimeter (mm)
Length
(mm)
2.75-2.25 3.00-2.50 3.50-3.00
30 143 187 187
40 191 250 250
50 239 312 312
60 286 375 375
Pharmacokinetics

@100% of drug elutes in 30days

 Biopoly – Biodegradable Polymer

• BioPoly is Meril’s propriety bio-degradable co-polymer

formulation is a 1:1 mix of PLGA & PLLA Before inflation
• The principle mode of BioPolyTM degradation is
hydrolysis via mass loss & by products are excreted as
CO2and H2O via Kreb’s cycle
• The material offers uniformity in stent coating & thin
coating of <2µm is possible
• Does-not web, crack, lump or on stent or balloon
surface After inflation
 Technical Specification

Stent System
• Stent Material : Cobalt chromium L605
• Strut Thickness : 65 µm
• Stent Diameter : 2.75-2.25, 3.00-2.50, 3.50-3.00 mm
• Stent Lengths : 30, 40, 50, 60 mm
• Mean Recoil : 3%
• Mean Foreshortening : 0.29%

Drug/Polymer
• Drug : Sirolimus
• Equivalent Drug Dose : 1.25 µgm/mm2 of stent surface area
• Polymer : Biodegradable; biocompatible (PLLA+PLGA)
 Technical Specification

Delivery System
• Delivery System : Rapid Exchange
• Stent Diameter (mm) : Crossing Profile (mm/inches)
2.75-2.25 0.93/0.037”
3.00-2.50 0.99/0.039”
3.50-3.00 1.03/0.040”
• Usable Catheter Length : 142 cms
• Balloon Characteristics : Semi-compliant
• Balloon Overhang : < 0.5 mm
• RO Markers : 2 – Platinum-Iridium
• Nominal Pressure : 9 ATM
• Rated Burst Pressure : 14 ATM
• Shaft Outer Diameter : Proximal 2.13F; Distal 2.7F
• Guide Catheter Compatibility : 5F (Min. I.D. 0.056” / 1.42 mm)
• Max. Guide Wire : 0.014” (0.36 mm)
 Ordering Information

12 SKUs to choose from!

Dia / Length 30mm 40mm 50mm 60mm

2.75-2.25 mm BIM27525030 BIM27525040 BIM27525050 BIM27525060

3.00-2.50 mm BIM30025030 BIM30025040 BIM30025050 BIM30025060

3.50-3.00 mm BIM35030030 BIM35030040 BIM35030050 BIM35030060

Code Cracker
BIM27522530

Length

BioMime Morph Diameter

 BioMime Morph –
Sirolimus Eluting Tapered Coronary Stent System

World’s first & only

tapered coronary DES
DCGI & CE approved
 BioMime Morph in Clinical Practice

BioMime Morph in RCA

• 52y/M with h/o exertion chest pain NYHA class II since 1 week
• Known diabetic and hypertensive
• ECG – normal sinus rhythm
• Echo – normal LV function
• TMT – positive at 8 METS
 BioMime Morph in Clinical Practice

Diffused RCA Lesion Guide wire advanced

This BioMime Morph Case is courtesy Dr. T R Raghu, Jayadeva Hospital, Bangalore
 BioMime Morph in Clinical Practice

Pre-dilatation BioMime Morph 2.75-2.25x60

This BioMime Morph Case is courtesy Dr. T R Raghu, Jayadeva Hospital, Bangalore
 BioMime Morph in Clinical Practice

BioMime Morph 2.75-2.25x60 Final Result

This BioMime Morph Case is courtesy Dr. T R Raghu, Jayadeva Hospital, Bangalore
 BioMime Morph in Clinical Practice

BioMime Morph in LAD

• 67y/M with typical chest pain since 1 hour

• Rapidly deteriorated into cardiogenic shock within 30mins of
admission
• Known hypertensive
• Normal sinus rhythm
• Echo showed concentric LVH
 BioMime Morph in Clinical Practice

Diffused LAD Lesion Guide wire advanced

This BioMime Morph Case is courtesy Dr. T R Raghu, Jayadeva Hospital, Bangalore
 BioMime Morph in Clinical Practice

BioMime Morph 3.50-3.00x60 Post Dilatation

This BioMime Morph Case is courtesy Dr. T R Raghu, Jayadeva Hospital, Bangalore
 BioMime Morph in Clinical Practice

Final Result Final Result

This BioMime Morph Case is courtesy Dr. T R Raghu, Jayadeva Hospital, Bangalore
Correct anatomical treatment –
BioMime Morph
 Thank you for your attention!

BioMime
Morph
SES

BioMime
Aura
SES

BioMime
SES

NexGen
Co-Cr