News | September 29, 2009

Abiomed Reports Positive Results From Three-Year Follow-up of Impella Patients

September 29, 2009 – Abiomed Inc. announced new clinical data last week at TCT 2009 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. The initial four-month results, which demonstrated significant recovery of left ventricular function in Impella 2.5 patients, were published in the Journal of American College of Cardiology in 2008.

The three-year follow-up results from MACH II were presented by Jose Henriques, M.D., Ph.D., Academic Medical Center, University of Amsterdam, at the Abiomed customer evening symposium at TCT 2009. The results measured the three-year follow-up of 20 large anterior STEMI patients in the MACH II trial and demonstrated significant overall improvements in cardiac function as well as quality of life in the ten patients that received Impella 2.5 within the trial.

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 percent at the baseline, to 41 percent in the four-month analysis, to 51 percent at the three-year follow-up period. Left ventricular ejection fraction in the control patients increased from 40 percent at the baseline, to 45 percent after the four-month analysis to 47 percent 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 seven ejection fraction points.

Abiomed said 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. Impella 2.5 patients saw no effects on aortic valve at three-year follow-up

“The initial MACH II results demonstrated that Impella had sustained benefits at four months and the three-year analysis, showing a 10 percent increase in ejection fraction, is an even stronger indicator that this device will make a significant difference in AMI treatment,” said Dr. Henriques. “Additionally, these findings could suggest that Impella 2.5 patients who have been discharged have higher rates of recovery and lower chances of hospital re-admittance.”

For more information: www.abiomed.com

Related Content

Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
CMS considers eliminating cardiac bundled payments.
Feature | Business| August 16, 2017 | Dave Fornell
August 16, 2017 — The Centers for Medicare and Medicaid Services (CMS) announced a proposed rule to reduce the number
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Four Blue Cross Blue Shield Companies Issue Positive Medical Policies on HeartFlow FFRct Analysis
News | FFR Catheters| August 09, 2017
HeartFlow Inc. announced that four Blue Cross Blue Shield companies have each issued a positive medical policy for the...
Overlay Init