Healthcare Industry News: SYNTAX trial
News Release - September 22, 2009
Abiomed Presents Results from USpella; First U.S. Registry Data Evaluating 181 Patients from 16 Centers with IRB Approval
DANVERS, Mass., Sept. 22--(HSMN NewsFeed)--Abiomed Inc. (NASDAQ: ABMD ), a leading provider of breakthrough heart support technologies, today announced new clinical data from USpella, the first U.S. multicenter registry of Impella 2.5 patients evaluating the safety and feasibility of left ventricular support with the Impella 2.5 during high-risk percutaneous coronary intervention (PCI) and treatment of acute myocardial infarction (AMI).USpella, presented at TCT 2009 by Brijeshwar Maini, M.D., co-chair, cardiovascular research, interventional cardiologist, Pinnacle Health; attending cardiologist, Moffitt Heart & Vascular Group, evaluated data from 16 Impella 2.5 centers with IRB approval and over 181 patients from the more than 1,000 reported commercial Impella 2.5 cases. The registry examined both high-risk PCI and AMI patients, reporting the following results:
High-Risk PCI patient results in USpella
- In 64% of the high-risk PCI cases, the patients had been turned down for CABG before treated with Impella 2.5
- The high-risk PCI population presented with a more complex anatomy than the SYNTAX trial population (of 23), decreasing SYNTAX score from 38 to 18 after effective revascularization with Impella 2.5
- Registry results reaffirmed ejection fraction increases that were similar to PROTECT I results, with improved ejection fraction in USpella high-risk PCI patients increasing from 29 to 34, after Impella 2.5 support
- Reported overall MACE was low at 6%
- 30-day survival rate was 97%
AMI patient results in USpella
- Impella was used after conventional therapies failed, (88% after emergent revascularization; 88% after high-dose inotropes; 68% after IABP therapy)
- Impella improved hemodynamics in AMI shock patients, improving cardiac index from 1.9 to 2.5 l/min/m2, increasing mean arterial pressure from 62 to 87 mmHg, and decreasing wedge pressure from 28 to 20 mmHg, as well as decreasing overall Systemic Vascular Resistance (SVR)
- After Impella 2.5 support, overall ejection fraction in AMI patients improved from 29 to 37%;
- Impella successfully supported AMI refractory shock patients with 69% survival to the next therapy or onto recovery. Also, 58% of AMI shock patients and 89% of AMI patients with no shock were discharged
Maini concludes that, “USpella is the largest IRB registry reported so far for Impella 2.5 that confirms prior positive study results. Impella is safe and easy to use, provides excellent support to stabilize the patients during high risk PCI and restores the hemodynamics in unstable conditions refractory to conventional therapies.”
Further commentary on USpella will be discussed at the Abiomed Evening Customer Symposium at the Hilton San Francisco on Tuesday, September 22, beginning at 7 p.m.. Also revealed during the Abiomed Evening Customer Symposium, will be the three-year follow-up of the MACH II trial will be presented by Jose PS Henriques, M.D., PhD., Academic Medical Center, University of Amsterdam.
The USpella presentation will also be given on Wednesday, September 23, during the Abiomed TCT Breakfast Session, to begin at 6:30 a.m. in Room 114A at the Moscone Convention Center.
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 development of Abiomed's existing and new products, the Company's progress toward commercial growth, and future opportunities and expected regulatory approvals. 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, iPulse, BVS5000, AB5000, AbioCor and the Abiomed logo are all trademarks of Abiomed. Other company and product names may be trademarks of their respective owners.
Source: Abiomed
Issuer of this News Release is solely responsible for its
content.
Please address inquiries directly to the issuing company.
