REabSORB : A STENT THAT DISAPPEARS

IDEA GENERATED & PRESENTED BY :MINAL CHAUHAN - 7MALVIKA BANSAL - 11SHILPA TAHAKAR - 14

JOURNEY

1) INTRODUCTION2) CURRENT SITUATION3) MARKET STUDY4) PRE LAUNCH SURVEY5) NEW PRODUCT DEVELOPMENT6) POST LAUNCH STRATEGY7) BENEFITS8) EXPECTED OUTCOME9) SUPPLEMENTARY SLIDES

JOURNEY

1) INTRODUCTION2) CURRENT SITUATION3) MARKET STUDY4) PRE LAUNCH SURVEY5) NEW PRODUCT DEVELOPMENT6) POST LAUNCH STRATEGY7) BENEFITS8) EXPECTED OUTCOME9) SUPPLEMENTARY SLIDES

Commonest cause of coronary artery blockage

Results in a fixed blockage

May be accompanied by coronary spasm

ATHEROSCLEROSIS

CYCLE

A mesh 'tube'

Inserted into a natural passage/conduit in the body

Treats narrow or weak arteries

STENT

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

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 cross-section of the compressed plaque and stent-widened artery

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

JOURNEY

1) INTRODUCTION2) CURRENT SITUATION3) MARKET STUDY4) PRE LAUNCH SURVEY5) NEW PRODUCT DEVELOPMENT6) POST LAUNCH STRATEGY7) BENEFITS8) EXPECTED OUTCOME9) SUPPLEMENTARY SLIDES

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

JOURNEY

1) INTRODUCTION2) CURRENT SITUATION3) MARKET STUDY4) PRE LAUNCH SURVEY5) NEW PRODUCT DEVELOPMENT6) POST LAUNCH STRATEGY7) BENEFITS8) EXPECTED OUTCOME9) SUPPLEMENTARY SLIDES

JOURNEY

1) INTRODUCTION2) CURRENT SITUATION3) MARKET STUDY4) PRE LAUNCH SURVEY5) NEW PRODUCT DEVELOPMENT6) POST LAUNCH STRATEGY7) BENEFITS8) EXPECTED OUTCOME9) SUPPLEMENTARY SLIDES

STRATEGIES

Meeting doctors

Understanding consumer requirements

Analyzing current problems

Conducting survey through questionnaires

Which is the most commonly used STENT ?

Which kind of STENT is a better option?

JOURNEY

1) INTRODUCTION2) CURRENT SITUATION3) MARKET STUDY4) PRE LAUNCH SURVEY5) NEW PRODUCT DEVELOPMENT6) POST LAUNCH STRATEGY7) BENEFITS8) EXPECTED OUTCOME9) SUPPLEMENTARY SLIDES

Circumferential PLLA hoops

150 µm thick

Hoops directly joined by bridges

BASIC DESIGN

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

COMPONENTS

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

JOURNEY

1) INTRODUCTION2) CURRENT SITUATION3) MARKET STUDY4) PRE LAUNCH SURVEY5) NEW PRODUCT DEVELOPMENT6) POST LAUNCH STRATEGY7) BENEFITS8) EXPECTED OUTCOME9) SUPPLEMENTARY SLIDES

Strategies

Spreading awareness

Contacting doctors & MRs

One on one presentations

Hiring professionals for personal selling

Taking feedback

JOURNEY

1) INTRODUCTION2) CURRENT SITUATION3) MARKET STUDY4) PRE LAUNCH SURVEY5) NEW PRODUCT DEVELOPMENT6) POST LAUNCH STRATEGY7) BENEFITS8) EXPECTED OUTCOME9) SUPPLEMENTARY SLIDES

Polymers are biocompatible

100% drug elution in 4 months

Complete healing of endothelium possible

No corrosion or dislocation

JOURNEY

1) INTRODUCTION2) CURRENT SITUATION3) MARKET STUDY4) PRE LAUNCH SURVEY5) NEW PRODUCT DEVELOPMENT6) POST LAUNCH STRATEGY7) BENEFITS8) EXPECTED OUTCOME9) SUPPLEMENTARY SLIDES

Reduced stent thrombosis

Reduction in therapy time

Limited chances of re-placement requirement

JOURNEY

1) INTRODUCTION2) CURRENT SITUATION3) MARKET STUDY4) PRE LAUNCH SURVEY5) NEW PRODUCT DEVELOPMENT6) POST LAUNCH STRATEGY7) BENEFITS8) EXPECTED OUTCOME9) SUPPLEMENTARY SLIDES

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%

ASSUMPTIONS

TRIAL BUDGET BREAKDOWNTRIAL REQUIREMENTS COST INCURRED*

(Rs.)FOLLOW UP, 5 YRS, 50

PATIENTS 1,00,000 * 5 * 50 =

2,50,00,000 ANGIOGRAPHY, 50

PATIENTS 20,000 * 2 * 50 =

20,00,000 RESOURCE COST, 50

PATIENTS 60,000 * 50 =

30,00,000 MEDICAL COST, 50

PATIENTS 10,000 * 5 * 50 =

25,00,000 IVUs COST, 50

PATIENTS 50,000 * 50 =

25,00,000MISCELLANEOUS COSTS 2,00,000

TOTAL TRIAL COST 3,52,00,000* ALL FIGURES ARE IN APPROXIMATION

http://blog.mediligence.com/2007/05/12/drug-eluting-stents-2/

http://www.bioabsorbabletx.com

http://www.vascularconcepts.com

http://www.revespcardiol.org/en/influencia-trombosis-del-stent-relacion/articulo/13150746/

http://www.cxvascular.com

http://www.nbcnews.com

http://www.nhlbi.nih.gov

http://www.news-medical.net/health/Stent-Types.aspx

REFERENCES

http://www.abbottvascular.com