Key Developments For Abiomed Inc
Abiomed Inc (ABMD.O) (Consolidated Issue listed on NASDAQ Global Market)
ABIOMED, Inc. Reaffirms FY 2010 Revenue Guidance
ABIOMED, Inc. reaffirmed its fiscal 2010 revenue guidance and expects revenue to be in the range of $86-$91 million. According to Reuters Estimates, analysts were expecting the Company to report revenue of $87 million for the same period.
ABIOMED, Inc. Reports Results From Academic Medical Center's Three Year Follow Up Of MACH II Trial
ABIOMED, Inc. announced new clinical data from Academic Medical Center's (AMC) three year follow up results from patients in the Impella 2.5 arm of the MACH II trial, revealing improved left ventricular function, cardiac output and quality of life. The MACH II trial, evaluating safety and feasibility in STEMI, included 20 patients; 10 patients were treated with three days of Impella 2.5 support; 10 control patients were treated with routine standard of care. All patients were measured in an IRB approved protocol that calculated echo results, exercise testing and quality of life, and showed the following results from core laboratory analysis and strict processes: Left ventricular ejection fraction in Impella 2.5 patients increased from 28% at the baseline, to 41% in the four-month analysis, to 51% at the three-year follow-up period. Left ventricular ejection fraction in the control patients increased from 40% at the baseline, to 45% after the four-month analysis to 47% at the three year analysis. Impella 2.5 patients continued to show improvement in left ventricular ejection fraction, demonstrating a net increase of 23 ejection fraction points while control patients only showed a net increase of 7 ejection fraction points; Significant benefit in exercise capacity was demonstrated stronger by Impella 2.5 patients, than control patients, which also improves the quality of life for the patient; and Impella 2.5 patients saw no effects on aortic valve at three year follow up.
ABIOMED, Inc. Announces Results From USpella
ABIOMED, Inc. announced the 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). 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).
ABIOMED, Inc. Reaffirms FY 2010 Revenue Guidance
ABIOMED, Inc. reaffirmed its fiscal 2010 guidance and expects revenue to be in the range of $86 to $91 million. According to Reuters Estimates, analysts were expecting the Company to report revenue of $88 million for the same period.
ABIOMED, Inc. Issues FY 2010 Revenue Guidance Below Analysts' Estimates
ABIOMED, Inc. announced that for fiscal 2010, it expects revenue growth to be in the range of $86 million to $91 million. According to Reuters Estimates, analysts were expecting the Company to report revenue of $94 million for the same period.
