The Danvers, Mass.-based company said that the 3rd-gen device includes new features that allow for better care during percutaneous coronary interventions in high risk patients and for patients being treated with the Impella in the ICU.
“The ability to introduce the Impella device simply and swiftly even in the presence of challenging femoral or iliac arteries will be valuable for interventional cardiologists caring for high-risk patients during PCI and for those in cardiogenic shock. Enhanced flows will be very useful, as will the new guide wire repositioning unit which expands the options for access site closure or device exchanges,” chief medical officer Dr. Seth Bilazarian said in a prepared statement.
Abiomed touts the Impella platform as the world’s smallest heart pump line, and the only FDA-approved percutaneous ventricular assist device indicated as safe and effective for PCI in high risk patients and patients with acute myocardial infarction complicated by cardiogenic shock.
New features on the 3rd-gen Impella including higher flow to allow for maximum unloading of the heart in the cath lab, new guide wire re-access sheaths for reaccessing the femoral artery and a new insertion kit with a new 25cm introducer sheath. The new system also requires fewer steps for flushing the system as part of standard maintenance, the company said.
“It’s intuitive and user-friendly. It’s a time saver; you don’t question what’s coming next. This software will make it easier to take care of your patient in the ICU,” Christiana Gartner of the Greenville Health System, who tested the 3rd gen CP, said in prepared remarks.
“These additions to the Impella CP represent the continuous innovation and commitment to patients that you’ve known since Impella was first introduced nine years ago. We continue to believe that data-driven insights and clinical expertise, along with our 24×7 onsite and on-call support, can help hospitals improve patient outcomes and reduce costs,” prez & CEO Michael Minogue said in a press release.
Last week, Abiomed saw share prices dip after the company reported fiscal 4th-quarter earnings that missed expectations, despite a top-line gain of nearly 33%.