Upload
saurabh-gupta
View
101
Download
2
Tags:
Embed Size (px)
Citation preview
BACKGROUND
The introduction of angioplasty led to the development
of a completely new approach to treat CAD.
Until 1994, the percutaneous transluminal coronary
angioplasty (PTCA) was the alone treatment for
coronary artery disease.
However, the incidence of restenosis of coronary
arteries was an important problem, necessitating
repeated interventional procedures in 30% of patients
treated with PTCA alone.
Primary cause of restenosis in balloon angioplasty is
adverse vessel remodeling with constriction of the
vessel relative to the adjacent nondilated vessel.
TREATMENT OF CAD
Options Angioplasty
(PCI)
Stenting
Drug-Eluting
Bare Metal
Bioabsorbable
Balloon Angioplasty
Surgery
(CABG)
Lifestyle Changes
Medications
Stents prevent this unfavorable constrictive remodeling
and provide metal scaffolding to the vessel.
Drug-eluting stents not only prevent this constriction but
reduce the excessive neointimal growth as well.
Sigwart et al first reported the efficacy of stents in
reducing restenosis rates in 1987.
By 1994, the Food and Drug Administration (FDA) had
approved two stents (Gianturco-Roubin stent and the
Palmaz- Schatz stent).
HISTORY The term “stent” derives from a dental prosthesis developed
by the London dentist Charles Stent (1807–1885).
The first stents were implanted in human coronary arteries in 1986 by Ulrich Sigwart, Jacques Puel, and colleagues,Switzerland) in the peripheral and coronary arteries of eight patients.
Cesare Gianturco and Gary Roubin developed a balloon-expandable coil stent consisting of a wrapped stainless steel wire resembling a clamshell.
A phase II study evaluating the Gianturco-Roubin stent to reverse POBA in acute or threatened vessel closure was started in 1988, ultimately leading to United States Food and Drug Administration (FDA) approval for this indication in June 1993.
Julio Palmaz devised a balloon-expandable slotted stainless steel stent with rectangular diamond shaped slots is the mother of all the modern stents.
The wide acceptance of coronary stenting was based on the
results of the BElgian NEtherlands STENT (BENESTENT) and
the STent REStenosis Study (STRESS) trials, which showed
the superiority of stenting over balloon angioplasty.
In these studies, there was 20% to 30% reduction in clinical and
angiographic restenosis compared with Plain old balloon
angioplasty(POBA).
INDICATIONS OF CORONARY STENTING/PCI
(AHA/ACC)
STEMI -In patients with stable angina, medical
therapy is recommended as first-line therapy
unless one or more of the following indications for
cardiac catheterization and PCI or CABG are
present:
A change in symptom severity
Failed medical therapy
High-risk coronary anatomy
Worsening left ventricular (LV) dysfunction
Rescue PCI
NSTEMI/UA - guidelines recommend that an early
invasive approach (angiography and
revascularization within 24 hours) should be used to
treat patients pesenting with the following high-risk
features -
Recurrent angina at rest or low level of activity
PCI in the past 6 months or prior CABG
New ST-segment depression
Elevated cardiac biomarkers
Signs or symptoms of heart failure or new or worsening
mitral regurgitation
Hemodynamic instability
Sustained ventricular tachycardia
LV systolic function < 40%
High risk score (eg, Thrombolysis in Myocardial
Infarction [TIMI] score <2)
SPECIAL CONDITIONS
Diabetes mellitusHigher rate of repeat revascularization in patients with diabetes
mellitus treated with PCI than with CABG
Chronic kidney diseaseCABG is associated with a greater survival benefit than PCI
among patients with severe renal dysfunction
Previous CABGsimilar rates of mid- and long-term survival after PCI or repeat
CABG procedures.
Contraindication to Fibrinolysis
STENT VS CABG
PRO’s CON’s
Reduced restenosis after 6 months
Higher clinical success rates
Reduced need for subsequent
revascularisation
Late Stent thrombosis
Similar rates of major cardiac
events( SYNTAX trial)
Similar rates of sudden cardiac
death(MASS-II trial)
PCI VS MEDICAL THERAPY
As an initial management strategy in patients with
stable coronary artery disease, PCI did not
reduce the risk of death, myocardial infarction, or
other major cardiovascular events when added to
optimal medical therapy. (COURAGE trial.)
But the newer platinum-chromium ,everolimus
eluting stents have imroved these safety outcomes.
PLACEMENT OF STENT
Blockage is defined through coronary angiography and Intravascular ultrasonigraphy (IVUS) may be used to assess the lesion's thickness and hardness ("calcification").
Cardiac catheter is guided to the heart through femoral or brachial artery .
Guide wire is manipulated to lie across the blockage
Heparin is a given to prevent clotting
Stent balloon catheter is transported along the guide wire and is positioned over the blockage
Saline is pumped into the balloon to inflate it
Balloon is inflated for 30 to 60 seconds to expand the stent
The framework of the stent should in direct contact
with the walls of the vessel to minimize potential
complications such as blood clot formation.
FACTORS AFFECTING IDEAL STENT
SELECTION
Deliverability- Indicates the overall ease with
which the whole stent system can be ‘delivered’ to
the lesion site.
Trackability- The amount of effort or force needed
to move the stent through the coronary artery.
Good strut apposition- The ability of the stent to
sufficiently expand so that its struts abut against the
vessel wall
GOOD ANGIOGRAPHIC PROPERTIES OF STENT
•Radioopacity- Visibility of the stent under flouroscopy.
•Scaffolding – The amount of metal supporting or covering the
vessel wall and preventing plaque prolapse.
•Conformability- The flexibility of the stent to conform the
vessel wall.
•Placement Accuracy- The ability to accurately place the stent
over the body of the lesion which depend upon the stent and
markerband visibility and recoil.
•Minimum balloon overhang- The amount of expanded balloon
outside the ends of stent. it is equated with the amount of
trauma caused to the healthy tissue beyond the lesion.
DESIRABLE STENT CHARACTERISTICS
Low crossing profile
High Flexibility
High stent/host biocompatibililty
High radial strength
Low metallic surface area
Favourable radiographic properties
Good trackability
Easy deployment
TYPES OF STENTS1. Mechanism of expansion -Balloon expandable
- Self Expanding
2. Materials -Stainless steel
-Chromium/cobalt based alloy
-Nitinol
-Tantalum
-Pt, Ir
-Inert coating
- Biodegradable
3. Forms -Sheet
-Wire
-Tube
4. Manufacturing methods --Laser cut
-Water jet cutting
-Photo itching
4. Geometric configurations/
Designs
-Mesh structure
-Coil
-Slotted tube
- Ring
-Multi design
5. Addition to stents -Grafts
-Radio opaque markers
- coatings
EVOLUTION OF STENTS
Bare Metal Stents(BMS)
Drug Eluting Stents (DES)
Biodegradable stents/ scaffolds
BMS(BARE METAL STENT)
Became known as the “Achilles’ heel” of coronary stenting
Coronary restenosis 20-30% at 6 months
Better than POBA[STRESS and BENESTENT-1 ]
THERAPEUTIC AGENTS
Paclitaxel
Promoting tubulin polymerization and cell cycle arrest at
G2/M phase
Inhibiting the migration and proliferation of SMCs
Coroxane
Nanoparticle albumin bound paclitaxel (nab-paclitaxel)
To improve the solubility
Docetaxel
Semi-synthetic analogue
Better anti-proliferative properties
Sirolimus (Rapamycin)
A macrocyclic lactone inhibiting mtor
Inhibits the migration and proliferation of SMCs affecting G1 to S phase
Zotarolimus
The sirolimus analogues
Extremely lipophilic property and low water solubility
Everolimus
Sirolimus analogue
Absorbs to local tissue more rapidly and has a longer celluar residence
time and activity
Biolimus
OTHER AGENTS IN THE PIPELINE
Tacrolimus
Pimecrolimus
Curcumin
Resveratrol
CD 34 antibody(gene stents)
Anti-VEGF
STENT PLATFORMS
STENT MATERIALS- NON DEGRADABLE
MATERIAL
316L stainless steel(FIRST GENERATION)-
Excellent mechanical properties and corrosion
resistance
Ferromagnetic nature and low density make it a
non-MRI compatible
Poorly visible fluoroscopic material
First generation DESs,
Cypher (sirolimus-eluting stent, Cordis, Warren, NJ)
Taxus (paclitaxel-eluting stent, Boston Scientific,
Natick, MA)
SECOND GENERATION
CO-CR(COBALT -CHROMIUM)
Superior radial strength and improved radiopacity
Thinner stent struts
The second generation DES,
Xience V (everolimus-eluting stent,
Abott Vascular, CA)
Endeavor (zotarolimus-eluting stent,
Medtronic Vascular, Santa Rosa, CA).
THIRD GENERATION
Ta- tantalum
Ti(Titanium)
Pt-Ir , Pt-Cr
Excellent corrosion resistant material
Coated on 316L SS to improved biocompatibility
High density and non-ferromagnetic properties
Fluoroscopically visible and MRI compatible
Less inflammatory reactions
BIODEGRADABLE METALLIC
MATERIALS(ABSORBED RAPIDLY)
Pure Fe
Oxidation of Fe into ferrous and ferric irons
Mg alloys
There are two Mg alloys, AE2153 and WE4357, used
for making stents
Radiolucent
BIO-DEGRADABLE STENT MATERIALS
Poly-L-lactic acid (PLA)
Polyglycolic acid (PGA)
Poly(D,L-lactide/glycolide) copolymer (PDLA)
Polycaprolactone (PCL)
RATIONAL FOR BIODEGRADABLE STENTS
Metal stent drawbacks
Cause permanent physical irritation
Risk of long term endothelial dysfunction and chronic inflammation
Metal have thrombogenicproperties
Inability for the vessel to restore its a normal physiology
Biodegradable stent advantages
May eliminate early and late complications of bare-metal stents like Late Stent Thrombosis(LST)
Restore the vasoreactivity
Allow a gradual transfer of the mechanical load to the vessel
Higher capacity for drug incorporation and complex release kinetics
Facilitates repeat treatment at the same site
The need for a permanent prosthesis decreases
dramatically 6 months post-implantation
BVS VS. DES
Drug – Eluting Stent Bioabsorbable stent
Polymer not biocompatible Polymers are biocompatible
All the drug is not eluted 100% drug is eluted in 4 months
Incomplete healing of endothelium
Complete healing of endothelium
Problems with late and very late ST
No reports of ST fromphase I study
STENT DESIGN
On the basis of design, stents can be divided into
three groups: coil, tubular mesh, and slotted tube.
A. Coil stents are characterised by metallic wires or strips
formed into a circular coil shape
B. Tubular mesh stents consist of wires wound together
in a meshwork, forming a tube.
C. Slotted tube stents are made from tubes of metal from
which a stent design is laser cut.
COIL VS. TUBE
Coil design had greater strut width with gaps and
fewer or no connections between struts
However, the design lack radial strength, and the
wide gap allow tissues to dangle.
Tubularor corrugated stents are better than coil or
meshwire stents, in terms of a better acute and
midterm outcome.
In tubular, there are two type of specification
slotted tube and
modular tube.
Slotted tube stents resisted restenosis more than the
modular stents (22.1% vs 25.2%)
CLOSED CELL
Sequential ring construction
Regular peak-to-peak
connections.
Optimal scaffolding
Uniform surface, regardless
of the degree of bending.
Less flexible than a similar
open-cell design.
Periodic peak-to-peak
connections, peak-to-valley
connections, and mid-strut to
mid strut connections
The unconnected structural
elements contribute to
longitudinal flexibility.
OPEN CELL
SLOTTED TUBE
OTHER FACTORS AFFECTING CHOICE OF
STENT
Long vs. Short
Short stent has lower cases of restenosis than long stent.
Wide vs. Narrow
The wide diameter stent is more favorable than the narrow
one
More struts vs. less
Less struts induce less chance of restenosis compare to
more struts.
Thin strut vs thick strut
The stents with thinner struts is preferred for the design
of new stents.
They can reduce angiographic and clinical restenosis
more than those with thicker struts
Strut thickness was observed to be an independent
predictor of in-stent restenosis.
Novel metallic materials such as cobalt-chromium
alloy are being used nowdays which have reduce
strut thickness while maintaining adequate
radiovisibility and radial strength.
Stents with thinner struts and lower metal density
yield a lower risk of restenosis than those with
thicker struts, and should be used for high-risk
lesions such as those located in small vessels
where the risk of restenosis is often magnified.
SQUARE VS. ROUND STRUT CROSS-SECTION
Square vs. round strut cross-section
round strut cross-section without corners or sharp
edges is popular at present for smoothness design.
Rough vs smooth stent design
Increased biocompatibily
Reduced thrombus adhesion and neointimal
growth.
DRUG DELIVERY VEHICLES – COATING
POLYMER- DRUG CARRIERS IN DESS
Non biodegradable polymers
The first generation of DES
Cypher - polyethylene-co-vinyl acetate (PEVA)/poly-n-
butyl methacrylate (PBMA)
Taxus - polystyrene-b-isobutylene-b-styrene (SIBS)
The second generation of DES
Xience V – fluoropolymer
Endeavor - phosphorylcholine (PC)
BIODEGRADABLE STENTS DO THEIR JOB AND
DISSAPEAR !
Biodegradable polymers
Polylactic acid (PLLA)
Polyglycolic acid (PGA)
Polylactic-co-glycolic acid (PLGA)
Polycaprolactone (PCL)
Translumina modified stent surface containing micropores to enable the adsorption of
different organic substances.
Abizaid A , and Costa J R Circ Cardiovasc Interv
2010;3:384-393
Copyright © American Heart Association
DES ARE NOT FOR EVERYONE !
Cost is major limiting factor (60-70% more )
Need for Chronic anticoagulants(DAPT)
Patient not compliant for 12 mnth therapy
High risk of bleeding
Scheduled for any major surgery in next 12 mnths
Late stent restenosis(6mnth – 1 year) is a major
adverse effect
Bifurcated lesions have an unfavourable outcome
No significant difference in MI and sudden death.
Left main coronary involvement.
Long lesion, small vessels and diabetics.
RADIO-OPACITY ENHANCEMENTS
Stainless steel or nitinol - hard to see fluoroscopically.
Biodegradable stents are also radiolucent .
To improve X-ray visibility, markers are often attached
to the stents.
These additions are typically made from gold,
platinum or tantalum
Electroplating (with gold) is also being used to enhance
X-ray visibility
COMPLICATION OF STENTING
Stent Thrombosis(ST)
Perforation(0.2% to 1.0%)
Dissection
Infectious Endarteritis
Allergic Reactions
Stent embolization
Side branch occlusion
Vascular complications related to site of access
RISK FACTORS FOR STENT
THROMBOSISP
atie
nt b
ase
d • Smoking
• Diabetes
• Chronic kidney disease
• Thrombocytosis
• Discontinuation of antiplatelettherapy
• Surgical procedures
Le
sio
n b
ase
d • Diffuse disease
• Small vessel disease
• Bifurcating disease
• Thrombus containing lesions
Ste
nt based • Poor stent
expansion
• Edge dissection limiting inlow
• Thicker struts
• Strut fractures
• Hypersensitivity to any polymer of DES
ORAL ANTIPLATELET THERAPY:
RECOMMENDATIONS
Patients already taking daily aspirin therapy
should take 81 mg to 325 mg before PCI.
Patients not on aspirin therapy should be given
nonenteric aspirin 325 mg before PCI.
After PCI, use of aspirin should be continued
indefinitely(75 mg/day).
A loading dose of a P2Y12 receptor inhibitor
should be given to patients undergoing PCI with
stenting. Options include
Clopidogrel 600 mg (ACS and non-ACS patients)
Prasugrel 60 mg (ACS patients)
Ticagrelor 180 mg (ACS patients)
The loading dose of clopidogrel for patients undergoing PCI after fibrinolytic therapy should be 300 mg within 24 hours and 600 mg more than 24 hours after receiving fibrinolytic therapy.
In patients receiving a stent (BMS or DES) during PCI for ACS, P2Y12 inhibitor therapy should be given for at least 12 months. Options include clopidogrel 75 mg daily,prasugrel 10 mg daily, and ticagrelor 90 mg twice daily.
In patients receiving DES for a non-ACS indication, clopidogrel 75 mg daily should be given for at least 12 months if patients are not at high risk of bleeding.
In patients receiving BMS for a non-ACS indication, clopidogrel should be given for a minimum of 1 month and ideally up to 12 months (unless the patient is at increased risk of bleeding; then it should be given for a minimum of 2 weeks).
Prasugrel should not be administered to patients with a prior history of stroke or transient ischemic attack
Gp IIb/IIIa inhibitors
STEMI- Administer iv or intracoronary during PCI
- Not beneficial when administered upstream
NSTEMI- Beneficial at the time of PCI in patients not pretreated with
bivalirudin or clopidogrel
1. Abciximab: 0.25 mg/kg as an i.v. bolus, followed by 0.125mcg/kg/min
(maximum 10 mcg/min) for 12 hr
2. Eptifibatide: two 180-mcg i.v. boluses 10 minutes apart,followed by 2.0
mcg/kg/min i.v. for 12–24 hr
3. Tirofiban: 25 mcg/kg as an i.v. bolus, followed by 0.15 mcg/kg/min for 24
hr
An additional dose of 0.3 mg/kg IV enoxaparin should be
administered at the time of PCI to patients who have
received fewer than 2 therapeutic subcutaneous doses (eg,
1 mg/kg) or received the last subcutaneous enoxaparin
dose 8 to 12 hours before PCI.
For patients with heparin-induced thrombocytopenia, it is
recommended that bivalirudin or argatroban be used to
replace UFH
BMS VS DES VS BIOABSORBABLE STENTS
0
5
10
15
20
25
30
35
BMS Taxus Cypher Xience BVS
Pa
tie
nts
(%
)
MACE
TLR
Restenosis
StentThrombosis
MATRIX OF STENT FEATURES
Bare-Metal
Stents
Drug-eluting
Stent
Bioabsorbabl
e drug-
eluting Stent
Reduced Dual-
Antiplatelet
Therapy
No neointimal
hyperplasia
Restoration of
Vasomotion
Material
(Biocompatible)
FUTURE OF STENTING
Different drug combination on stent to
combat restenosis
Drug combination to increase endothelial
healing
Drug filled stents(polymer free)
Bioabsorbable stents
Stents with progenitor cells/stem cells
Gene therapy stents {anti cd34 ab}
Diamond –carbon coated stents
Stent Manufactu
rer
Drug Base Form/Desi
gn
Polymer Diameter Length
XIENCE
Xpedition
Abott
vascular
FDA
Approved
Everolimus
100μg/cm2
L-605 CoCr Hybrid cell
Multilink
0.0032" strut
thickness,
laser cut
PBMA
Non erodible
SV-2.25
MV-
2.5,2.75,3.0,3.
25,3.5,4.0
LL
2.5,2.75,3.0,
3.25,3.5,4.0
8,12,15,18,23
,28
33,38
XIENCE V Abott
vascular
FDA
Approved
Everolimus
100μg/cm2
Multi-layer
Coating
MULTI-LINK
VISION CoCr
stent
Hybrid cell
Multilink
0.0032" strut
thickness,
laser cut,
PBMA
Non erodible
2.25,2.5,2.75,
3.0,3.5,4.0
8,12,15,18,23
,28
XINCE
PRIME
Abott
vascular
FDA
Approved
Everolimus
100μg/cm2
Cobalt
Chromium
Hybrid cell
Multilink
0.0032" strut
thickness,las
er cut,
biocompatibl
e fluorinated
copolymer
SV-2.25
MV
2.5,2.75,3.0,
3.5,4.0
LL-
2.5,2.75,3.0,
3.5,4.0
8,12,15,18,23
,28
Same
33,38
Stent Manufactur
er
Drug Base Form/Desi
gn
Polymer Diameter Length
Promus element
Plus
Boston scientific Everolimus Platinum
Chromium
Tubular open
cell,thin
strut,high radial
strength,good
delieverality &
trackability
Thin, fluorinated
copolymer
matrix for
controlled drug
release (100%
drug elution in
120 days)
2.25,2.5,2.75,3.0
,3.5,4.0
8,12,16,20,24,28
,32,38
Endeavor Sprint Medtronic Zotarolimus-
Eluting
10μg/mm
cobalt-based
alloy (cobalt,
nickel,
chromium, and
molybdenum)
Modular
design,Sinusoid
al form
wire,helical
wrap,laser fused
Phosphorylcholi
ne polymer
2.25,2.5,2.75,3.0
,3.5,4.0
8,12,14,18,22,26
,30,34,38
Resolut Integrity Medtronic Zotarolimus
eluting
cobalt-based
alloy (cobalt,
nickel,
chromium, and
molybdenum)
Modular
design,Sinusoidal
form wire,helical
wrap,laser fused
BioLinx
biocompatible
polymer
2.25,2.5,2.75,3.0
,3.5,4.0
8,12,14,18,22,26
,30,34,38
Stent Manufactur
er
Drug Base Form/Desi
gn
Polymer Diameter Length
Taxus Liberte Boston Scientific Paclitaxel
1 μg/mm2
paclitaxel in a
slow release
(SR)*
316L surgical
grade stainless
steel
Sinusoidal ring
modules linked
via curved link
elements
SIBS
[poly(styrene-b-
isobutylene-b-
styrene)], a tri-
block copolymer
(trade name:
Translute)
2.50, 2.75, 3.00,
3.50, 4.00
8, 12, 16, 20, 24,
28, 32
TAXUS Express Boston Scientific Paclitaxel
1μg/mm2
paclitaxel in a
slow release
(SR)
316L surgical
grade stainless
steel
modular ring
strut pattern
consists of two
separate module
designs: short,
narrow
sinusoidal Micro
elements linked
via straight
articulations to
long, wide
sinusoidal Macro
elements
SIBS
[poly(styrene-b-
isobutylene-b-
styrene)], a tri-
block copolymer
(trade name:
Translute)
2.50, 2.75, 3.00,
3.50
8, 12, 16, 20, 24,
28, 32
Taxus Element Boston Scientific Paclitaxel
1.0 μg/mm2
Platinum
Chromium
Sinusoidal ring
modules
consisting of
alternating long
and short
crowns linked
SIBS
[poly(styrene-b-
isobutylene-b-
styrene)], a tri-
block copolymer
(trade name:
2.25,2.50,2.75,3.
0,3.5,4.0,4.5
8,12,16,20,24,28
,32,38
Stent Manufactur
er
Drug Base Form/Design Polymer Diameter Length
Coracto Alvimedica Rapamycin Stainless
steel
Tubular,open cell
design
Ultrathin
polymer layer
absobes 100%
in 10-12 week
2.5,2.75,2.90,3
.00,3.5,4.0
9,13,17,21,26,
28,32
Coroflex
please
B.Braun Paclitaxel
1μg/cummStainless
steel
Multicellular ring
design,Hybrid
Superb
radioopacity
P matrix-
polysulfone
coating
2.5,2.75,3.0,3.
5,4.0
8,13,16,19,25,
28,32
Cypher cordis Sirolimus
100% drug
release with in 1
month
Stainless
steel
Tubular,laser
cut,sinusoidal
pattern,closed cell
two non-erodible
polymers:
polyethylene-co-
vinyl acetate
(PEVA) and poly
n-butyl
methacrylate
(PBMA)
2.50, 2.75, 3.00,
3.50
8, 13, 18, 23, 28,
33
Stent Manufactu
rer
Drug Base Form/Desi
gn
Polymer Diameter Length
YUKON
Choice 4DES
Translumina,
German
CE mark
Sirolimus Medical
Stainless
Steel, 316
LVM, Surface
containing
micro-pores
1million
pores/sqcm
Balloon marker
material
Platinum /
Iridium
microporous
PEARL
Surface
Strut thickness
0,0034” / 87
μm
Hybrid design
Non
polymeric
Shellac resin
bio
compatible
resin
6 to 8 weeks
release
2.0,2.25,2.50,2
.75,3.0,3.5,4.0
8,12,16,18,21,
24,28,32,40
GEN X Sync MIV
therapeutics
India pvt ltd
Sirolimus Co Cr Open cell,
alternate S
link,uniform
sinusoidal strut
design
Bio resorb
PLLA-poly L
lactic acid
polymer
Ultrathin
coating(3μm)Drug sudden release f/b release upto 40-50 days.
2.0,2.25,2.50,2
.75,3.00,3.50,4
.0,4.5
8,13,16,19,24,
29,32,37
Supralimus Sahajanand
Medical
Technologies
Pvt Ltd, India
Sirolimus Sainless steel Hybrid biodegradable
drug-
carrier ,50%
drug release in
7 days next
50% in 41days
2.5,2.75,3.0,3.
5
8,12,16,20,24,
2832,36,40
Supralimus-
Core
Sahajanand
Medical
Technologies
Pvt Ltd, India
Sirolimus cobalt-
chromium
Hybrid biodegradable
drug-
carrier ,50%
drug release in
7 days next
50% in 41days
same same
Stent Manufactu
rer
Drug Base Form/Desi
gn
Polymer Diameter Length
BioMatrix Biosensors
Inc, Newport
Beach, Calif
CE mark
biolimus A9
highly
lipophilic,
semi
synthetic
sirolimus
analogue
(≈15.6 μg/mm
of stent
length)
S-Stent (316
L) stainless
steel stent
with a strut
thickness of
0.0054 inches
(137 μm)
laser-cut,
tubular stent
S-Stent
platform
Open cell,
quadrature
link
Biodegradabl
e,
Polylactic
acid (PLA)
applied to the
abluminal
surface
2.25,2.50,2.7
5,3.0,3.5,4.0
8,11,14,18,24
,28,33,36
Pronova Vascular
concepts,UK
Sirolimus Co Cr Hybrid
S shaped
articulations
Biocompatibl
e,biostable
polymer,drug
release upto
30 days
2.25,2.50,2.7
5,3.0,3.25,3.5
0,4.0
13,18,23,28,3
3,38
Biomime Meril Life
Sciences,
India
Sirolimus1.25μgm/sqmm of stent surface,30 day elution kinetics
Co Cr Hybrid cell
design
65μm strut
thickness
Biodegradabl
e polymer
2.5,2.75,3.0,3
.5,4.0,4.5
8,13,16,19,24
,29,32,37,40
Stent Manufactur
er
Drug Base Form/Desi
gn
Polymer Diameter Length
ACTIVE&
ACTVE small
IHT Paclitaxel Stainless steel Open
cell,tubular
P5 -
Biocompatible
polymer
2.0,2.25,2.5,2.
75,3.0,3.5,4.0,
4.5
9,14,18,19,23,
28,36
EVERLITE Unimark
remedies
Everolimus
Low drug dose
1.2μg/sqmm
Co Cr Open
cell,Sinosoidal
strut
design,alternativ
e S link,ultrathin
strut 65μm
Biodegradable 2.25,2.5,2.75,3.0
,3.5,4.0,4.5
8,13,16,19,24,29
,32,37,40
Flexy Rap Lancer medical
technology
Rapamycin
1μg/sqmmCo Cr Open
cell, Radial star
segments
combined with
flexible
links,Strut 65μm,
Biodegradable
polymer
2.25,2.5,2.75,3.0
,3.5,4.0
7,10,13,15,17,20
,24,28,33,38,42
INDOLIMUS
Ce mark
Sahajanand
medical
sirolimus Co Cr Open cell,laser
cut,seamless
tube,60 micm
strut thickness
Biodegradable
polymer matrix
2.5,2.75,3.0,3.5 8,12,16,20,24,28
,32,36,40