New Study with Abiomed's Impella 2.5® Heart Pump Demonstrates Potential Survival with Pre-PCI Insertion in Heart Attacks with the Left Main Coronary Artery
DANVERS, Mass., June 30, 2017 (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, announced today the recent publication of a peer-reviewed retrospective study on hemodynamic support with the Impella 2.5® heart pump. The study analyzed patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) undergoing a percutaneous coronary intervention (PCI) on an unprotected left main coronary artery (ULMCA)1. The study was published in the Journal of Interventional Cardiology. Results of the study suggest that initiation of Impella 2.5 heart pump prior to the start of a PCI on an ULMCA culprit lesion is associated with significant survival benefit in patients supported for cardiogenic shock following an AMI. Patients supported with the Impella 2.5 heart pump post-PCI appear to have very poor survival at 30 days. This study adds to the existing body of clinical data supporting the early placement of Impella heart pumps before PCI for patients in cardiogenic shock.
A heart attack in the left main is sometimes referred to as the "mother of all widow makers" because it carries a mortality rate of over 80%2,3. The left main coronary artery and its branches supply oxygenated blood to 75% of the heart's left ventricular muscle mass4. This important artery is the only source of blood and oxygen to the left side of the heart, thereby deemed 'unprotected' when there is no history of heart surgery to bypass the left main coronary artery.
Perwaiz Meraj, MD, and colleagues reported for the first time the real-world outcomes of Impella 2.5 use in PCI on a ULMCA culprit lesion in patients with AMICS. This multicenter, retrospective study included 36 patients from 19 U.S. sites participating in the cVAD Registry(TM)4 in order to assess whether the initiation of hemodynamic support before PCI would have a survival benefit compared to initiation of support after the PCI. The majority of these patients (average age 69) were in cardiogenic shock at the time of hospital admission (73%) and had a low mean ejection fraction of 25%.
Increased Survival and Heart Recovery Demonstrated
The study demonstrated a significant hospital survival benefit when Impella 2.5 was initiated prior to PCI.
|Impella after PCI (n=16)||p Value|
|Survival to Discharge||55||%||19||%||0.041|
|Survival at 30 Days||48||%||13||%||0.004|
"Patients with cardiogenic shock complicating an acute myocardial infarction due to an unprotected left main coronary artery culprit lesion are some of the sickest and most clinically challenging patients admitted in the cath lab," said Dr. Meraj, of Northwell Health and first author of this manuscript published in the Journal of Interventional Cardiology. "Our data suggests that early placement of Impella before PCI is vital to survival."
Reproducible Results Support the Benefit of Impella ® Placement Pre-PCI
These new data support prior publications with percutaneous heart pumps (such as Impella) supporting cardiogenic shock patients published in Journal of the American College of Cardiology (National trends in the utilization of short-term mechanical circulatory support)5 and the Journal of Interventional Cardiology (Use of Impella 2.5 in Acute Myocardial Infarction complicated by Cardiogenic Shock)6 representing nearly 12,000 Medicare/insurance patients and 154 cVAD Registry patients respectively. Additional data from Abiomed's observational IQ Database of 15,259 AMICS patients and data from the Detroit Cardiogenic Shock Initiative7,8 reinforce the best practice of placing Impella heart pump before PCI in cardiogenic shock patients.
"We commend Dr. Meraj and his coauthors on this application of real-world evidence," said Seth Bilazarian, MD, Chief Medical Officer of Abiomed. "We are pleased that this adds to the body of research showing the benefit of placing Impella early and before PCI in the setting of cardiogenic shock."
To learn more about the study from Dr. Meraj, visit www.protectedpci.com.
ABOUT IMPELLA HEART PUMPS
The Impella 2.5®, Impella CP® and Impella 5.0® are FDA-approved heart pumps used to treat heart attack patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart. The Impella 2.5 and Impella CP devices are also approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries. Abiomed's right-side heart pump, the Impella RP® device, is approved to treat certain patients experiencing right heart failure. To learn more about the Impella platform of heart pumps, including their approved indications and important safety and risk information associated with the use of the devices, please visit: www.protectedpci.com.
The ABIOMED logo, ABIOMED, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, and Recovering Hearts. Saving Lives. are registered trademarks of ABIOMED, Inc. in the U.S. and in certain foreign countries.
Based in Danvers, Massachusetts, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com.
This release contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the Company's progress toward commercial growth, and future opportunities and expected regulatory approvals. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company's filings with the Securities and Exchange Commission, including the most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.
Meraj, P. Impella 2.5 initiated prior to unprotected left main PCI in acute myocardial infarction complicated by cardiogenic shock improves early survival. J Interv Cardiol. 2017 Apr 17. doi: 10.1111/joic.12377. [Epub ahead of print]
De Luca G, Suryapranata H, Thomas K, van 't Hof AW, de Boer MJ, Hoorntje JC, Zijlstra F. Outcome in patients treated with primary angioplasty for acute myocardial infarction due to left main coronary artery occlusion. Am J Cardiol. 2003 Jan 15;91(2):235-8.
Lee MS, Tseng CH, Barker CM, Menon V, Steckman D, Shemin R, Hochman JS. Outcome after surgery and percutaneous intervention for cardiogenic shock and left main disease. Ann Thorac Surg. 2008 Jul;86(1):29-34Kalbfleisch H, Hort W. Quantitative study on the size of coronary artery supplying areas postmortem, Am Heart J , 1977, vol. 94 (pg. 183-188)
The cVAD Registry (formerly known as the U.S. Impella registry) contains nearly 3,000 patient records and includes Institutional Review Board (IRB) approval, complete data monitoring and Clinical Events Committee adjudication. It is subject to FDA definitions and audits.
Stretch, R. National trends in the utilization of short-term mechanical circulatory support: incidence, outcomes, and cost analysis. J Am Coll Cardiol. 2014 Oct 7;64(14):1407-15. doi: 10.1016/j.jacc.2014.07.958.
O'Neill, W. The current use of Impella 2.5 in Acute Myocardial Infarction complicated by Cardiogenic Shock: Results from the USpella Registry. J Interv Cardiol. 2014 Feb; 27(1): 1-11. doi: 10.1111/joic.12080.
O'Neill, W. Outcomes for 15,259 US Patients With Acute MI Cardiogenic Shock (AMICS) Supported With Impella; data presented also included early findings from the Detroit Cardiogenic Shock Initiative (DCSI). Presented at the 66th Annual Scientific Session of the American College of Cardiology, Washington, DC. 2017 March.
The mission of the IQ Assurance Program is to improve real-world outcomes in Protected PCI and cardiogenic shock patients through training, education and utilization of clinical guidelines, protocols and best practices derived from observational quality assurance data (IQ), IRB approved registry data (cVAD) and IDE approved FDA studies. The points reflected specifically in the IQ Database, as compared to the IQ Program, which includes the cVAD Registry and FDA studies, are not statistically-powered or pre-specified, and no statistical conclusions can be drawn from the observational database.
**For further information please contact:
Senior Director, Public Relations and Corporate Communications
Ingrid Goldberg Ward
Director, Investor Relations
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Abiomed via Globenewswire
Om Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
CrownBio Launches an Innovative Grant Program to Fund Advancements in Preclinical Oncology Research17.11.2017 18:07 | Pressemelding
SANTA CLARA, Calif., Nov. 17, 2017 (GLOBE NEWSWIRE) -- Crown Bioscience, a wholly-owned subsidiary of Crown Bioscience International (TWSE:ticker 6554) and a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, announces the launch of a grant program supporting oncology research scientists which provides funding for projects that show promise for scientific advancement of Patient Derived Xenograft (PDX) technology. Research Grants up to $50,000 will be awarded to projects focused on accelerating the pace of preclinical innovation and novel PDX methodologies that improve clinical predictions with sound science. The program offers an opportunity for investigators to receive funding for projects that may not receive support through traditional funding channels. Submitted proposals will be reviewed and selected by CrownBio's Scientific Steering Committee with the goa
Barings Backs Sentinel Capital Partners in Acquisition of Nekoosa17.11.2017 17:00 | Pressemelding
CHARLOTTE, N.C., Nov. 17, 2017 (GLOBE NEWSWIRE) -- Barings, one of the world's leading asset management firms, announced today that it served as Lead Agent on a senior secured credit facility to support Sentinel Capital Partners in its acquisition of Nekoosa ("Nekoosa" or the "Company"). Headquartered in Nekoosa, Wisconsin, the Company is a leading manufacturer of specialty paper and film products used in the graphics and commercial print markets, including application and pressure-sensitive tapes, specialty synthetic papers, sheeted digital and offset grade carbonless paper, and extruded film products. Nekoosa serves a highly diverse base of more than 70,000 commercial print and graphics shops in 65 countries. Barings served as lead senior lender on the transaction, which included a senior term loan and a revolving credit facility. "Sentinel is pleased to have Barings' support on our investment in Nekoosa," said Scott Perry, a partner with Sentinel Capital Partner
At SC17, ExaScaler and PEZY Computing Unveil Gyoukou Supercomputer with a High Combined Green500/Top500 Ranking16.11.2017 23:29 | Pressemelding
ExaScaler and PEZY Computing Also Take Top Three Green500 Positions DENVER, Nov. 16, 2017 (GLOBE NEWSWIRE) -- At SC17, ExaScaler and PEZY Computing unveiled their Gyoukou supercomputer whose Green500 and Top500 rankings attest to a unique combination of high efficiency and computing power. The Gyoukou supercomputer is installed at the Yokohama Research Institute in Japan. (Video: PEZY Liquid immersion cooling) PEZY supercomputers leverage 48V Factorized Power, a high efficiency, high density power distribution architecture. PEZY's CPUs are co-packaged with Vicor's Power-on-Package ("PoP") Modular Current Multipliers ("MCMs"), which enable efficient, direct 48V to sub-1V current multiplication at the XPU. ExaScaler and PEZY Computing also achieved the #1, #2 and #3 positions on the Green500. These supercomputer system installations also utilize 48V Factorized Power. Come see us at SC17 at Booth 633 where ExaScaler / PEZY Computing will be
ELS Educational Services, Inc. Launches New Vacation English Program Starting January 201816.11.2017 20:59 | Pressemelding
New York, New York, Nov. 16, 2017 (GLOBE NEWSWIRE) -- ELS Educational Services, Inc. - one of the leading language services providers worldwide - has launched a new vacation English language program, ELS Language Experience+, which is set to begin enrollment for January 2018. "Here at ELS, our students and their English language goals always come first, and we are proud to introduce ELS Language Experience+ as an exciting new addition to the many quality programs we offer them," said ELS Chief Operating Officer, Reiji Terasaka. "This conversation-oriented, flexible new vacation English program allows students to make the most of their English instruction while gaining an invaluable cultural experience at the same time." ELS Language Experience+ concentrates on everyday speaking, communication skills and discussion, within a flexible course structure (three or six hours of study per day). Courses offered include: Everyday English, Grammar in Action, D
Global SD-WAN Partnership between CallTower and Aryaka to Deliver High-Performance Cloud Communication Solutions to Global Enterprises16.11.2017 16:02 | Pressemelding
SAN MATEO, Calif., Nov. 16, 2017 (GLOBE NEWSWIRE) -- Aryaka, the leading global SD-WAN provider, today announced a new partnership with CallTower, an industry-leading unified communications and collaboration company, to provide global enterprise customers with fast and reliable, high-quality cloud service connectivity. CallTower's partnership with Aryaka will deliver improved performance of their unified communications solutions to global enterprise customers. CallTower has linked their data centers with the Aryaka global network to deliver secure, reliable connectivity with quality of service guarantees for mission critical real-time communication applications. CallTower Cisco and Microsoft unified communications solutions, including Cloud Contact Center customers will now be able to add Aryaka's global SD-WAN service to further optimize, and enhance reliability over a secure network. "In addition to our unified communications offering, we have seen tremendous growth i
Gunvor Secures US $1.39 Billion Revolving Credit Facility16.11.2017 15:00 | Pressemelding
Gunvor Group Ltd / Gunvor Secures US $1.39 Billion Revolving Credit Facility . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement. Strong bank support for Group strategy results in substantial over-subscription GENEVA, Nov. 16, 2017 (GLOBE NEWSWIRE) -- Gunvor Group Ltd ("Gunvor" or the "Group") has signed a US $1.39 billion Revolving Credit Facility ("RCF") in favour of Gunvor International B.V. and Gunvor SA (the "Borrowers"). The RCF, launched at US $1 billion, was substantially over-subscribed, drawing in US $1.81 billion, a record high for the facility. The RCF was scaled back to accommodate the needs of the Group, which will use the funds to finance general corporate purposes and working capital requirements. "Gunvor continues to receive considerable support from both its exis
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom