The document presents a proposal for a bioresorbable stent called REabSORb. It discusses the current issues with permanent metal stents, including risks of blood clots. REabSORb would dissolve completely in 2-3 years using polymers and drug coatings. It outlines the product development process including design, components, testing assumptions and budget. The proposal suggests it would provide benefits like reduced risk of clots or re-intervention compared to permanent stents.

1. REabSORb :
a STENT THaT
DISaPPEaRS
IDEa GENERaTED &
PRESENTED bY :
MINaL CHaUHaN - 7
MaLVIKa baNSaL 11
SHILPa TaHaKaR -

2. JOURNEY
1)
2)
3)
4)
5)
6)
7)
8)
9)
INTRODUCTION
CURRENT SITUaTION
MaRKET STUDY
PRE LaUNCH SURVEY
NEW PRODUCT DEVELOPMENT
POST LaUNCH STRaTEGY
bENEFITS
EXPECTED OUTCOME
SUPPLEMENTaRY SLIDES

3. JOURNEY
1)
2)
3)
4)
5)
6)
7)
8)
9)
INTRODUCTION
CURRENT SITUaTION
MaRKET STUDY
PRE LaUNCH SURVEY
NEW PRODUCT DEVELOPMENT
POST LaUNCH STRaTEGY
bENEFITS
EXPECTED OUTCOME
SUPPLEMENTaRY SLIDES

4. aTHEROSCLEROSI
S
 Commonest cause of coronary artery blockage
 Results in a fixed blockage
 May be accompanied by coronary spasm

5. CYCLE

7. STENT
 A mesh 'tube'
 Inserted into a natural passage/conduit in the body
 Treats narrow or weak arteries

8.  Stents usually are made of metal mesh, but
sometimes they're made of fabric
 Fabric stents, also called stent grafts, are used in
larger arteries
 Some stents are coated with medicine that is slowly
and continuously released into the artery

11.  Figure A shows the location of the heart and coronary arteries
 Figure B shows the deflated balloon catheter and closed stent inserted into
the narrow coronary artery
 The inset image shows a cross-section of the artery with the inserted balloon
catheter and closed stent
 In figure C, the balloon is inflated, expanding the stent and compressing the
plaque against the artery wall
 Figure D shows the stent-widened artery. The inset image shows a crosssection of the compressed plaque and stent-widened artery

12. RISKS RELaTED TO STENTS
 Blood clot at the stent site
 Blood clots can cause a heart attack, stroke, or other
serious problems
 Stents coated with medicine may raise the risk of
dangerous blood clots

13. JOURNEY
1)
2)
3)
4)
5)
6)
7)
8)
9)
INTRODUCTION
CURRENT SITUaTION
MaRKET STUDY
PRE LaUNCH SURVEY
NEW PRODUCT DEVELOPMENT
POST LaUNCH STRaTEGY
bENEFITS
EXPECTED OUTCOME
SUPPLEMENTaRY SLIDES

14. STRAIN TAKES TOLL ON
HEART
 Hypertension : three times higher in urban citizens
than their rural counterparts
 9% of population in the age bracket of 40-70 undergo
angioplasty every year
 BMS is the most popular choice
 Several post surgery complications are involved

20. JOURNEY
1)
2)
3)
4)
5)
6)
7)
8)
9)
INTRODUCTION
CURRENT SITUATION
MARKET STUDY
PRE LAUNCH SURVEY
NEW PRODUCT DEVELOPMENT
POST LAUNCH STRATEGY
BENEFITS
EXPECTED OUTCOME
SUPPLEMENTARY SLIDES

25. JOURNEY
1)
2)
3)
4)
5)
6)
7)
8)
9)
INTRODUCTION
CURRENT SITUATION
MARKET STUDY
PRE LAUNCH SURVEY
NEW PRODUCT DEVELOPMENT
POST LAUNCH STRATEGY
BENEFITS
EXPECTED OUTCOME
SUPPLEMENTARY SLIDES

26. STRATEGIES
 Meeting doctors
 Understanding consumer requirements
 Analyzing current problems
 Conducting survey through questionnaires

28. Which is the most commonly used STENT ?

30. Which kind of STENT is a better option?

31. JOURNEY
1)
2)
3)
4)
5)
6)
7)
8)
9)
INTRODUCTION
CURRENT SITUATION
MARKET STUDY
PRE LAUNCH SURVEY
NEW PRODUCT DEVELOPMENT
POST LAUNCH STRATEGY
BENEFITS
EXPECTED OUTCOME
SUPPLEMENTARY SLIDES

34. BASIC DESIGN
 Circumferential PLLA hoops
 150 µm thick
 Hoops directly joined by bridges

35. COMPONENT
S
 PLLA (Poly-L-Lactic Acid) Backbone
 PDLLA (Poly-D, L-Lactic Acid) Coating
 Drugs coated on it include :
VEGF (Vascular Endothelial Growth Factor) to

promote healing

ASPIRIN to reduce the ability of blood to clot
easily
 STATIN to help in reabsorbing cholesterol

37.  Both the backbone and coating will degrade to
lactic acid (Kreb’s cycle)
 Drugs coated on it are to serve their respective
function
 Entire stent should dissolve in 2-3 yrs without
any side effects

39. JOURNEY
1)
2)
3)
4)
5)
6)
7)
8)
9)
INTRODUCTION
CURRENT SITUATION
MARKET STUDY
PRE LAUNCH SURVEY
NEW PRODUCT DEVELOPMENT
POST LAUNCH STRATEGY
BENEFITS
EXPECTED OUTCOME
SUPPLEMENTARY SLIDES

40. StrategieS
 Spreading awareness
 Contacting doctors & MRs
 One on one presentations
 Hiring professionals for personal selling
 Taking feedback

41. JOUrNeY
1)
2)
3)
4)
5)
6)
7)
8)
9)
iNtrODUCtiON
CUrreNt SitUatiON
MarKet StUDY
Pre LaUNCH SUrVeY
NeW PrODUCt DeVeLOPMeNt
POSt LaUNCH StrategY
BeNeFitS
eXPeCteD OUtCOMe
SUPPLeMeNtarY SLiDeS

42.  Polymers are biocompatible
 100% drug elution in 4 months
 Complete healing of endothelium possible
 No corrosion or dislocation

43. JOUrNeY
1)
2)
3)
4)
5)
6)
7)
8)
9)
iNtrODUCtiON
CUrreNt SitUatiON
MarKet StUDY
Pre LaUNCH SUrVeY
NeW PrODUCt DeVeLOPMeNt
POSt LaUNCH StrategY
BeNeFitS
eXPeCteD OUtCOMe
SUPPLeMeNtarY SLiDeS

44.  Reduced stent thrombosis
 Reduction in therapy time
 Limited chances of re-placement requirement

45. JOUrNeY
1)
2)
3)
4)
5)
6)
7)
8)
9)
iNtrODUCtiON
CUrreNt SitUatiON
MarKet StUDY
Pre LaUNCH SUrVeY
NeW PrODUCt DeVeLOPMeNt
POSt LaUNCH StrategY
BeNeFitS
eXPeCteD OUtCOMe
SUPPLeMeNtarY SLiDeS

46. aSSUMPtiON
S
 Pre-supposed approval by FDA
 Rs. 90,000 : average cost of a stent in India
 Based on historical precedence, our price 2.5 lakh at
initial entry
 20% hurdle rate
 Total cost inclusive of trials : 8 crores
 Profit Margin of 65%

47. triaL BUDget
BreaKDOWN COST INCURRED*
TRIAL REQUIREMENTS
(Rs.)
FOLLOW UP, 5 YRS, 50
1,00,000 * 5 * 50 =
PATIENTS
2,50,00,000
ANGIOGRAPHY, 50
20,000 * 2 * 50 =
PATIENTS
20,00,000
RESOURCE COST, 50
60,000 * 50 =
PATIENTS
30,00,000
MEDICAL COST, 50
10,000 * 5 * 50 =
PATIENTS
25,00,000
IVUs COST, 50
50,000 * 50 =
PATIENTS
25,00,000
MISCELLANEOUS COSTS
2,00,000
TOTAL TRIAL COST
3,52,00,000
* ALL FIGURES ARE IN APPROXIMATION

48. reFereNCe
http://blog.mediligence.com/2007/05/12/drug-eluting-stents-2
S
/
http://www.abbottvascular.com
http://www.bioabsorbabletx.com
http://www.vascularconcepts.com
http://www.revespcardiol.org/en/influencia-trombosis-del-stentrelacion/articulo/13150746/
http://www.cxvascular.com
http://www.nbcnews.com
http://www.nhlbi.nih.gov
http://www.news-medical.net/health/Stent-Types.aspx