Abiomed is a publicly traded Massachusetts-based medical device manufacturer. It reports that it has now invested more than $100 million of clinical research in its Impella heart pump platform.
What is Impella?
According to Abiomed, Impella is the only FDA approved, safe and effective device for high-risk PCI, cardiogenic shock, and right-side support. The company positions that most FDA cleared medical devices, such as the intra-aortic balloon pump and ECMO are not necessarily backed by randomized controlled trial evidencing safety and efficacy. In the case of Abiomed’s Impella, they point out, Impella went through the Protect II trial producing greater evidence of efficacy and safety. More than 100,000 patients have been treated with Impella in the U.S., Germany and Japan.
What is the Protect II Trial?
In Protect II Trial, Abiomed was published in ClinicalTrials.gov. Abiomed positions that although coronary artery bypass grafting is generally preferred in symptomatic patients with severe, complex multivessel, or left main disease, some patients present with clinical features that make coronary artery bypass grafting (CABG) clinically unattractive. A note that CABG is a type of surgery that improves blood flow to the heart. Surgeons will at times use CABG to treat patients who have severe coronary heart disease. Percutaneous coronary intervention with hemodynamic support may be feasible for patients that are not CABG candidates. Presently there is no systematic comparative evaluation of hemodynamic support devices for this indication.
Protect II Methods and Results
Abiomed randomly assigned 452 symptomatic patients with complex 3-vessel disease or unprotected left main coronary artery disease and severely depressed left ventricular function to intra-aortic balloon pump (IABP) (n=226) or Impella 2.5 (n=226) support during nonemergent high-risk percutaneous coronary intervention. The primary end was the 30-day incidence of major adverse events. A 90-day follow-up was required, as well, by protocol. Impella 2.5 provided superior hemodynamic support in comparison with IABP, with maximal decrease in cardiac power output from baseline of −0.04±0.24 W in comparison with −0.14±0.27 W for IABP (P=0.001). The primary end (30-day major adverse events) was not statistically different between groups: 35.1% for Impella 2.5 versus 40.1% for IABP, P=0.227 in the intent-to-treat population and 34.3% versus 42.2%, P=0.092 in the per protocol population. At 90 days, a strong trend toward decreased major adverse events was observed in Impella 2.5–supported patients in comparison with IABP: 40.6% versus 49.3%, P=0.066 in the intent-to-treat population and 40.0% versus 51.0%, P=0.023 in the per protocol population, respectively.
The 30-day incidence of major adverse events was not different for patients with IABP or Impella 2.5 hemodynamic support. However, trends for improved outcomes were observed for Impella 2.5–supported patients at 90 days.
Summary of Investments in Impella
Abiomed-sponsored research has been augmented, it is claimed, by two decades of independent physician-led research initiatives and a total of more than 550 peer-reviewed academic papers. Those studies have confirmed the hemodynamic benefits of Impella, which directly unloads the left ventricle and enables heart recovery. As a result, Impella is included in eight clinical guidelines and has regulatory approvals that include European CE Mark, Japanese PMDA, and the highest level of regulatory from the US FDA, the PMA.
Ongoing post-market surveillance investments.
- The Impella Quality Assurance (IQ) Database
- The company markets that it represents one of the most extensive post-market surveillance programs in the medical device industry including the following:
- Impella Quality Assurance (IQ) database
- FDA-audited cVAD study
- Real-time monitoring
- 10 trials (some completed, some ongoing)
- To date, Abiomed’s commitment to clinical research has supported