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Abiomed Reports Updated USpella Results Presented at EuroPCR 2010

^{Published on 2010-05-25 04:30:28 - Market Wire}
 

DANVERS, Mass.--([ BUSINESS WIRE ])--[ Abiomed Inc ]. (NASDAQ: ABMD), a leading provider of [ breakthrough heart support technologies ], today announced that updated clinical data from USpella will be presented at EuroPCR 2010. USpella is a U.S. multicenter, observational registry of [ Impella 2.5 ]® patients.

The updated USpella results will be presented at EuroPCR during a scientific poster session by William Oa™Neill, M.D., University of Miami Miller School of Medicine, on Wednesday, May 26. The results will also be presented at Abiomeda™s symposium on the evening of Thursday, May 27. Details are at the end of the press release.

The USpella registry results were originally announced on September 22, 2009 at TCT 2009. The new updates, presented at EuroPCR 2010, announce that a total of 62 U.S. and Canada centers have been invited to participate in the registry. Of these, 45 centers have accepted the invitation and have begun the IRB approval process. Eighteen of these centers have completed the process, are open for enrollment and have contributed data on a total of 301 patients. Since the original update at TCT 2009, an independent Clinical Executive Committee (CEC) has been established to adjudicate adverse event reporting. As of March 31, 2010, a total of 251 of the 301 patient data reports have completed the CEC adjudication process and are presented in this update.

The updated registry will report the following:

Prophylactic Impella support:

• 52% of patients improved New York Heart Association (NYHA) classification by one or more categories after Impella-supported complex PCI.
  • Prior to treatment, 63% of patients were in NYHA class three or four.
  • After treatment, 70% were in NYHA class one or two.
• The target population for ICD implantation (according to AHA/ACC Practice Guidelines) was reduced 29% by reducing the number of patients with LVEF a 30% (62% of patients had LVEF a 30% prior to treatment which was reduced to 44% of patients after treatment).
• Mean ejection fraction in this patient group increased from 31% to 37% after Impella 2.5 support.
• 56% of patients supported with Impella for complex PCI had been declined for a surgical bypass procedure due to their morbidity.
• Reported overall MACE was low at 8%.
• 30-day survival rate was 96%.

Emergent Impella support:

• In AMI Shock patients, Impella was used after conventional therapies failed - 79% after emergent revascularization, 81% after high-dose inotropes and 85% after IABP therapy.
• Patients that were failing IABP therapy before switching to Impella experienced a 44% gain in systolic blood pressure, 49% gain in diastolic blood pressure and 46% gain in MAP once they were switched over:

• Overall hemodynamics improved with Impella support in this patient group, with cardiac index increasing from 1.8 to 2.5 l/min/m2, MAP increasing from 61 to 87 mmHg, and wedge pressure decreasing from 29 to 19 mmHg.
• After Impella 2.5 support, mean ejection fraction in the AMI shock patients improved from 30% to 34%.
• The 30 day survival rate of these patients after failing other options was 58%.

Today at EuroPCR, a poster featuring USpella will be displayed in the exhibition hall, located on the first level. The poster will also be presented in the exhibition hall at 12 p.m. on Wednesday, May 26 and Thursday, May 27.

The USpella presentation will also be given during Abiomeda™s symposium, presented by William Oa™Neill, M.D. University of Miami Miller School of Medicine on Thursday, May 27, at 4:30 p.m. (CEST) in Room Vend'me Technique.

ABOUT ABIOMED

Based in Danvers, Massachusetts, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support to acute heart failure patients across the continuum of care in heart recovery. Our products are designed to enable the heart to rest, heal and recover by improving blood flow and/or performing the pumping of the heart. For additional information please visit: [ www.abiomed.com ].

FORWARD-LOOKING STATEMENTS

This Release contains forward-looking statements, including statements regarding The results to date of the USpella registry. The actual results of the USpella registry may differ materially in the future and the Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, including anticipated future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company's filings with the Securities and Exchange Commission, including the Annual Report filed on Form 10-K and most recently filed Quarterly Report on Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this Release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this Release or to reflect the occurrence of unanticipated events.

Abiomed, Impella, BVS5000, AB5000, AbioCor and the Abiomed logo are all trademarks of Abiomed. Other company and product names may be trademarks of their respective owners.