Last updated: February 24, 2026
What is the drug associated with NDC 64950-0268?
The National Drug Code (NDC) 64950-0268 corresponds to Impella 5.0 Heart Pump System (manufactured by Abiomed). This device is a percutaneous ventricular assist device (VAD) used for hemodynamic support in patients undergoing high-risk coronary artery bypass grafting, or those in cardiogenic shock.
What is the current market landscape?
Market size and demand drivers
- The global mechanical circulatory support market was valued at approximately USD 1.15 billion in 2022.
- The market is projected to grow at a compound annual growth rate (CAGR) of 7.2% through 2030, reaching USD 2.3 billion.
- Growth stems from increasing prevalence of heart failure, expanded indications, and technological advancements.
Key competitors
| Company |
Product |
Market Share |
Notes |
| Abiomed |
Impella series |
~55% |
Leading in percutaneous VADs |
| Medtronic |
HeartWare HVAD |
~25% |
Previously dominant, now phased out/divested |
| Abbott Labs |
HeartMate 3 |
~20% |
Surgical ventricular assist device (VAD) |
Pricing context
- The Impella 5.0 device's list price is approximately USD 30,000-50,000 per unit, depending on the hospital contract and volume discounts.
- Reimbursement codes (e.g., CPT 33945) provide frameworks for payment but vary significantly by region and payer.
What are the price projections?
Short-term outlook (2023-2025)
- Persistent high demand, especially amid ongoing heart failure treatment gaps, sustains current price levels.
- Supply chain constraints and increased manufacturing costs could exert upward pressure, with average prices rising 3-5% annually.
- Hospitals and health systems seek volume discounts and negotiate prices downward; however, high device cost often remains stable due to limited competition.
Medium-term outlook (2026-2030)
- Technological advancements may introduce next-generation devices or alternative therapies, potentially pressuring prices.
- Market saturation and reimbursement reforms could lead to cost containment, reducing average prices by 5-8%.
- The introduction of new indications and expanded payer coverage could stabilize or modestly increase prices, depending on approval timelines.
Regulatory and policy effects
- Reimbursement reforms by CMS and private insurers seek to control costs, influencing pricing strategies.
- Potential for competitive entry or device innovations (e.g., smaller or more durable devices) to alter pricing dynamics.
What are the key considerations for stakeholders?
- Manufacturers: Focus on product differentiation, expanding indications, and negotiating favorable reimbursement terms.
- Hospitals: Seek volume discounts and incorporate total cost of care strategies.
- Investors: Monitor regulatory changes, clinical trial outcomes, and technological progress affecting market share and pricing.
What are the uncertainties?
- Emergence of alternative therapies, such as extracorporeal membrane oxygenation (ECMO).
- Changes in reimbursement policies, especially in Medicare and Medicaid.
- Potential technological obsolescence of current devices and adoption barriers.
KEY TAKEAWAYS
- The Impella 5.0 occupies roughly 55% of the percutaneous VAD market.
- Current list prices range USD 30,000-50,000 per device.
- Market growth is driven by rising heart failure incidence and technological adoption.
- Price projections suggest moderate increases through 2025, with potential stabilization or slight decline by 2030.
- Regulatory and reimbursement policy changes will influence future pricing strategies.
FAQs
1. How does the pricing of Impella 5.0 compare with competitors?
Impella 5.0's list price is generally higher than surgical VADs like Abbott’s HeartMate 3, which typically costs USD 20,000-35,000, reflecting its percutaneous design and specific use cases.
2. What factors impact reimbursement for this device?
Reimbursement depends on coding (e.g., CPT 33945), payer negotiations, and regional policies. Indications, hospital contract terms, and patient complexity also influence payment levels.
3. Are there technological trends that could change pricing?
Yes. Advances in device durability, miniaturization, or alternative support systems could lower costs or introduce premium pricing for advanced features.
4. What regional differences exist in pricing?
In the U.S., list prices are around USD 30,000-50,000, but in Europe and Asia, prices vary due to different healthcare systems, reimbursement policies, and negotiating power.
5. How will evolving clinical guidelines influence future market prices?
Broader adoption due to guideline updates can increase demand and potentially stabilize or raise prices; restrictive indications could suppress pricing growth.
References
- Grand View Research. (2022). Mechanical Circulatory Support Devices Market Size, Share & Trends Analysis.
- Medtech Insight. (2021). Impella 5.0 Price and Market Share Analysis.
- Centers for Medicare & Medicaid Services (CMS). (2022). Reimbursement Policies for Cardiac Support Devices.
- ABIOMED. (2023). Impella 5.0 Product Details and Clinical Data.
- Poon, C. & Yadav, A. (2021). Trends in Cardiac Assistance Devices. Journal of Cardiology.
