Corrected Nov. 15, 10:15 a.m. to reflect that the Protect II study compared the Impella pump to intra-aortic balloon pump therapy, not to shock therapy.
Abiomed Inc. (NSDQ:ABMD) unveiled Symphony, its new implantable heart pump for the treatment of patients with chronic moderate heart failure.
Symphony is designed as a low cost alternative for New York Heart Association Class III patients who respond poorly to standard treatments. The Danvers, Mass.-based company’s implanted cardiac device is the first designed for heart recovery and remodeling.
Symphony’s simple design means a lower price tag than conventional therapies, and the minimally invasive procedure should lead to a shorter hospital stays, according to the company.
The heart pump was unveiled today at the American Heart Assn.’s conference in Florida and, according to the company, the first in-man procedure is expected outside the U.S. in early 2012.
Abiomed announced the results of its Impella 2.5 system’s Protect II trial at this year’s Transcatheter Cardiovascular Therapies conferences, which aimed to "determine the safety and effectiveness of the Impella 2.5 as compared to optimal medical management with an intra-aortic balloon pump, during "high-risk" angioplasty procedures," Abiomed spokeswoman Aimee Maillett told MassDevice.
Results of the 426-patient trial showed that the next-generation Impella system led to a reduction in adverse events in and out of the hospital as well as repeat vascularization when compared to IABP therapy.
The Protect II trial assessed the use of the Impella mechanical pump inside blood vessels and the heart to channel blood flow from the heart’s left ventricle, compared with using an intra-aortic balloon pump.
Abiomed’s Impella pump, which won FDA clearance in June 2008, makes up the bulk of its sales, accounting for $22 million during the three months ended June 30, 2011.
The company credited the workhorse device with leading it to the best year in its history. Abiomed posted 12-month sales of $101 million, an 18 percent spike from the previous year, for its fiscal 2011 year.
The double-digit growth in Impella sales made the company a Zacks Investment Research favorite, alongside Medtronic Inc. (NYSE:MDT), St. Jude Medical Inc. (NYSE:STJ), Boston Scientific Corp. (NYSE:BSX) and others.