Patients using an Abiomed Inc. heart pump showed significant long-term improvement in heart function, according to new clinical data released this week during a company event in the Netherlands.
According to the data, overall heart function — as measured by the volume of blood pushed out of the heart and throughout the body with each heart beat — continued to rise after three years in patients treated with the Danvers, Mass.-based firm’s Impella 2.5 pump, compared with a similar assessment four months following the procedure.
A total of 850 patients were treated with the device during the three months ended in June. U.S. regulators approved the device in June 2008; it and a pair of related devices approved earlier this year were responsible for about 60 percent of global revenues for the Danvers, Mass.-based company during the fiscal 2010 first quarter.
Specifically, left ventricular ejection fraction in Impella 2.5 patients rose to 51 percent after three years, according to the study, up from 41 percent at the four-month mark. The increase was significantly higher than that of a control group, which had an ejection fraction of 45 percent at four months and a 47-percent fraction after three years.
Abiomed’s Mach II study compared a 10-patient group, treated with three days of Impella 2.5 support following surgery, and a 10-patient group treated with routine standard of care. The study also found that the Impella 2.5 recipients demonstrated improved ability to exercise and a marked improvement in quality of life.
The latest data were released during an evening customer symposium at the Transcatheter Cardiovascular Therapeutics Conference 2009 in San Francisco by Dr. Jose Henriques of the Academic Medical Center at the University of Amsterdam. The initial four-month clinical results were reported last year in the Journal of American College of Cardiology.
The trial results at four months and three years out show “sustained benefits” for Impella 2.5 patients, indicating that “this device will make a significant difference in [acute myocardial infraction] treatment,” Henriques said, adding that discharged Impella 2.5 patients might “have higher rates of recovery and lower chances of hospital re-admittance.”
Abiomed released a study earlier this week indicating the Impella 2.5 device is safe and easy to use during high-risk percutaneous coronary intervention and treatment of heart attacks.