Abiomed touts another Impella study

December 17, 2009 by MassDevice staff

Abiomed Inc. (NSDQ:ABMD) is touting the results of a new, European study showing the effectiveness of its Impella 2.5 circulatory assist device in high-risk percutaneous coronary intervention procedures.

The Danvers, Mass.-based cardiac assist device maker said the study, "Supported High-Risk Percutaneous Coronary Intervention Using the Impella 2.5 device: The Europella Registry," was published in the Dec. 15 issue of the Journal of the American College of Cardiology. It concludes that "this large multicenter registry supports the safety, feasibility and potential usefulness of hemodynamic support with Impella 2.5 in high-risk PCI."

The Europella registry is the largest multicenter study of high risk PCI using the Impella, according to a press release. The 10-center study looked at 144 consecutive high-risk PCI patients with complex or high-risk coronary lesions, such as last remaining vessel or left main lesions.Abiomed summarized the study and results as follows:

Patient Population:

• Patients were older, 62% older (Mean age, 71.8 years)
• 54% had an LV ejection fraction of 30% or less
• The prevalence of comorbidities was high and the Mean European System for Cardiac Operative Risk Evaluation score was 8.2± 3.4
• 43% of the patients were refused for coronary artery bypass graft (CABG)
• Left main coronary artery (LMCA) PCI, last patent vessel PCI, and complex multi-vessel disease (MVD) comprised 52%, 17%, and 82% of the cases, respectively

Device Outcomes

• Successful passage through the femoral artery and implantation of the Impella 2.5 into the left ventricle was achieved in all 144 patients
• A low rate of major adverse cardiac and cerebrovascular, 0% device malfunction and low rate of complications confirming the safety, ease of use and potential effectiveness of the technology for high risk PCI. The primary feasibility endpoint included successful deployment, operation and explantation of the Impella 2.5.

It's the second positive study this year for the Impella 2.5 and PCI, following the September release of the USpella trial results. That study involved 181 patients who underwent high-risk PCI and acute myocardial infarction treatments using the device, which is a small pump inserted into the heart via catheter during cardiac procedures.

Abiomed said those data indicate that high-risk PCI patients in the study, 64 percent of whom were deemed ineligible for coronary artery bypass graft surgery, showed improved levels of heart function (ejection fraction, a measure of how well the organ is pumping). Those patients also showed a low incidence (6 percent) of major adverse cardiac events and a 30-day survival rate of 97 percent.

The MCI patients were treated using the device after other, conventional treatments failed. The study showed that those patients also exhibited improved ejection fractions. In cases where the patients went into shock despite intervention, 69 percent survived until the next therapy or recovered; 58 percent of the shock patients were discharged. Eighty-nine percent of patients with no shock were discharged as well.

Impella sales and net losses rose for Abiomed during its fiscal 2010 second quarter. Second-quarter sales reached $20 million during the three months ended Sept. 30, flat compared with the same number during the second quarter of fiscal 2009. Net losses for the quarter gapped to $7.7 million, compared with $6.3 million during Q2 2009.

But Impella sales continued their year-long rise. The devices accounted for $10.5 million in worldwide sales during the second quarter last year and $13.2 million during Q2 2010 — a 26 percent jump. And the average number of patients using the device per week also soared, rising 225 percent from eight a year ago to 26 during the 2010 second quarter.

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