June 12, 2017 — Abiomed Inc. recently released its third-generation Impella CP heart pump at the 2017 meeting of the Society for Cardiovascular and Angiography Interventions (SCAI). The technology offers new features for optimal care during a percutaneous coronary intervention (PCI) in high-risk patients known as a Protected PCI, and for patients being treated with Impella in the intensive care unit (ICU).
The new Impella CP is a member of the Impella family of heart pumps which have the unique ability to unload the heart and enable native heart recovery, potentially allowing patients to return home with their own hearts. As the world’s smallest heart pump, the Impella platform has supported more than 50,000 patients in the U.S. and is the only U.S. Food and Drug Administration (FDA)-approved percutaneous ventricular assist device (pVAD) indicated as safe and effective for PCI in high-risk patients and patients with Acute Myocardial Infarction complicated by Cardiogenic Shock (AMICS).
Higher Flows, Ability to Maintain Access to Arteriotomy
There are several new features on the Impella CP 3rd Generation that simplify patient management:
· To maximize unloading of the heart in the cath lab, this next generation heart pump enables higher flow. Clinicians could see peak flows above 4 liters/minute for patients whose hearts need additional pumping support
· New guide wire re-access sheath allows clinicians to re-access the femoral artery which enables the clinician to rapidly escalate care if needed
· For ease of use, the insertion kit contains a new, proprietary, 25 cm introducer sheath to facilitate the insertion of the device in challenging or tortuous femoral vessels, thus increasing the number of patients who could benefit from percutaneous hemodynamic support. This unique, long introducer sheath can be removed after pVAD insertion with a simple peel-away technique that is not possible with any other kind of introducer
“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,” explained Seth Bilazarian M.D., FACC, FSCAI, chief medical officer of Abiomed and experienced interventional cardiologist. He continued, “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.”
Fewer Steps for the Heart Team
The ability to maintain access to the arteriotomy is particularly vital to the care of patients supported by the Impella device in the ICU long-term, such as those in cardiogenic shock. In addition, the Impella CP third-generation heart pump offers fewer steps when flushing the system as part of standard maintenance.
"It’s intuitive and user-friendly,” said Christiana Gartner, RN, a nurse educator and experienced ICU nurse with extensive Impella experience at Greenville Health System who had the opportunity to test features of the newest CP. She continued, “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."
Like all Impella heart pumps for the left side, the Third-generation CP devices are designed for optimal positioning in the left ventricle and feature a flexible catheter, radiopaque marker, cannula shape and pigtail. The 3rd Generation Impella CP devices are now available in the U.S.
Real-world Data Showing Improved Outcomes
Since the Impella platform received pre-market approval (PMA) from the FDA for AMICS in April, 2016, Abiomed has continued tracking best practice data in the Impella Quality (IQ) Assurance Program, a real-world collection of clinical information derived from the treatment of patients with Impella devices since 2008. Results reveal that across sites using Impella devices to treat AMICS:
· There has been an observed 14 percent relative improvement in survival as compared to the year before the FDA approval
· In 2016, there were 89,000 AMICS cases nationwide with only 6 percent, or approximately 5,000, treated with Impella heart pumps.
· For more real-world evidence on the use of Impella, please see the Presentation on Abiomed's Impella® Quality (IQ) Assurance Program and Importance of Treatment Protocols to Improve Patient Survival and Heart Recovery.
For additional information: www.abiomed.com