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Are all stents equal - Need for scoring system to evaluate stents?
1Professor of Cardiology, AIIMS, Delhi, India.
Indian Heart Journal
|October 25, 2016
Summary
Drug-eluting stents (DES) are highly advanced, yet new versions are frequently released. Distinguishing true innovation from pipeline extensions is crucial for regulatory and pricing strategies.
Area of Science:
- Cardiovascular devices
- Medical technology innovation
- Drug delivery systems
Background:
- Drug-eluting stents (DES) represent a mature technology with incremental advancements.
- The market sees frequent releases of new DES versions, often termed 'new generations'.
- There is a need to differentiate genuine technological leaps from minor modifications.
Discussion:
- The distinction between pipeline extension and true innovation in DES technology is unclear.
- This ambiguity impacts regulatory assessment and product valuation.
- Accurate classification is essential for fair market pricing and R&D investment.
Key Insights:
- Current drug-eluting stent (DES) technology is highly sophisticated.
- A clear definition is needed to differentiate incremental updates from groundbreaking innovations.
- This classification impacts regulatory pathways and market value.
Outlook:
- Future DES development may focus on defining and achieving true generational improvements.
- Regulatory bodies may require clearer distinctions for new device approvals.
- Accurate product valuation will depend on demonstrating genuine innovation over pipeline extensions.
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