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Abiomed Medical Office Completes Review of Observational Analysis of Impella Presented at AHA

Nachrichtenquelle: Business Wire (engl.)
19.11.2019, 19:11  |  305   |   |   

Abiomed (NASDAQ: ABMD) is committed to improving patient outcomes by performing FDA studies and post-market surveillance, collecting real-world evidence and identifying and sharing best practices. Impella is the most studied mechanical circulatory support device in the history of the FDA with real-world clinical data on more than 110,000 patients in the Impella Quality (IQ) Database, FDA randomized controlled trials (RCT) and post-approval studies with greater than 5,000 patients, and more than 550 peer-reviewed publications. Impella is proven to provide superior hemodynamic support over the intra-aortic balloon pump (IABP).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191119005932/en/

Figure 1: Clinical Variables Poorly Matched in Amin, et al. (Graphic: Business Wire)

Figure 1: Clinical Variables Poorly Matched in Amin, et al. (Graphic: Business Wire)

Today the Abiomed medical office is issuing a publication review of the observational analysis of Impella that was presented by Amin et al. at the American Heart Association Conference (AHA) on November 17. A video summarizing the review’s findings posted today at this link on ProtectedPCI.com.

The AHA analysis is flawed because:

  1. The data source has significant limitations, containing just a fraction of Impella patients and unable to delineate between common adverse events
  2. The Impella patients were much sicker and had greater baseline and procedural risks
  3. The analysis excluded the costliest IABP patients who were escalated to other therapies

Additionally, the conclusion is aggressive because administrative coding data cannot delineate between adverse events common to high-risk patients and device related events.

Data Source Has Significant Limitations

The AHA analysis is an observational, unaudited data analysis based on a retrospective, administrative sample coding database that does not identify device related adverse events and lumps multiple indications together, including elective high-risk and emergent cardiogenic shock cases. This makes it impossible to properly propensity match. The sample coding database only includes 4% of the Impella patients who are studied in the IQ Database.

Impella Patients Were Much Sicker

Compared to the IABP patients, the Impella patients:

  • Were older
  • Had nearly 50% greater rate of diabetes
  • Had 50% greater rate of heart failure
  • Had nearly 2x the rate of chronic renal failure at baseline
  • Had 2x the rate of multi-vessel disease
  • Underwent 4x the rate of LASER atherectomy
  • Underwent 5x the rate of rotational atherectomy
  • Had nearly 2x the rate of NSTEMI

The Analysis Excluded the Costliest IABP Patients Who Were Escalated to Other Therapies

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