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
Följ NASDAQ OMX
Abonnera på våra pressmeddelanden.
Senaste pressmeddelandena från NASDAQ OMX
Gratomic Announces Non-Brokered Private Placement21.7.2018 19:41 | Pressmeddelande
TORONTO, July 21, 2018 (GLOBE NEWSWIRE) -- Gratomic Inc. ("GRAT" or the "Company") (TSX-V:GRAT) (FRANKFURT:CB81) (WKN:A143MR) is pleased to announce the offering of a non-brokered private placement of up to 20,000,000 working capital units (the "WC Unit") for up to $2,000,000 (the "Offering"). Each WC Unit is priced at $0.10 and consists of one (1) common share and one (1) common share purchase warrant ("WC Warrant"). Each WC Warrant entitles the holder to purchase one (1) common share (a "WC Warrant Share") at a price of $0.20 per WC Warrant Share until the earlier of: (i) three (3) years following the Closing of the Offering; and (ii) in the event that the closing price of the Common Shares on the TSX Venture Exchange is at least $0.30 for ten (10) consecutive trading days, and the 10th trading day (the "Final Trading Day") is at least four (4) months from the Closing Date, the date which is thirty (30) days from the Final Trading Day. Eligible Finders may receive 5% of the value of
eGain Enables Conversational Customer Service Through Apple Business Chat20.7.2018 12:30 | Pressmeddelande
SUNNYVALE, Calif. and NEWBURY, United Kingdom, July 20, 2018 (GLOBE NEWSWIRE) -- eGain (NASDAQ:EGAN), the leading provider of cloud-based customer engagement solutions, today announced its integration with Apple Business Chat. According to Gartner, requests for customer support through consumer mobile messaging apps will exceed requests for customer support through traditional social media by 2019*. Moreover, 56% of consumers surveyed in a Nielsen study would rather message a business than call customer service, and 67% expect to message businesses even more over the next two years. Key capabilities Among key capabilities of the integrated solution are: Enabling hundreds of millions of consumers on iPhone and iPad to interact with businesses through the Messages app Leverage eGain AI to infer customer intent, power bot conversations through messaging, route escalations to contact center agents, and guide agents through messaging conversations Provide immersive customer experiences with
Marcus Hiles - Texas Takes #1 Four Years in a Row in America's Top States for Business19.7.2018 23:39 | Pressmeddelande
DALLAS, July 19, 2018 (GLOBE NEWSWIRE) -- The future business scene in Texas is looking brighter than ever as the state continues to hold its place as a national leader. Growth is spreading across areas such as North Texas, Houston and San Antonio with businesses quickly expanding their operations in the state that offers some of the best in business-friendly climates and overall growth potential. Tapping into the market recently are global leaders such as Toyota, Liberty Mutual and JP Morgan who have taken advantage of the state's increasing network of commercial properties, workforce and business resources. Named by CNBC for the fourth consecutive year as America's Top State for Business, Texas scored above all 50 states on overall business competitiveness. With the business hub building on its role as a national leader for the past decade, this top rank title reflects the progress Texas has made in cementing its place in the global economy. "This national recognition comes without s
Second Quarter 2018 Results Conference Call19.7.2018 21:34 | Pressmeddelande
AURORA, Ontario, July 19, 2018 (GLOBE NEWSWIRE) -- Magna International Inc. (TSX:MG) (NYSE:MGA) SECOND QUARTER 2018 RESULTS CONFERENCE CALL WEDNESDAY - AUGUST 8th, 2018 7:30 AM ET DIAL IN NUMBERS North America Toll Free: International Toll: Webcast: 1-888-223-4641 1-416-981-9080 www.magna.com Slide presentation will be available on our website prior to the call. REBROADCAST INFORMATION Replay available 2 hours after the call until August 15, 2018 North America Toll Free: International Toll: Reservation No.: 1-800-558-5253 1-416-626-4100 21892829 INVESTOR CONTACT Louis Tonelli, Vice-President, Investor Relations firstname.lastname@example.org, 905-726-7035 TELECONFERENCE CONTACT Nancy Hansford, Executive Assistant, Investor Relations email@example.com, 905-726-7108 This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients. The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originali
Uganda National Airlines Company Limited Signs Firm Order for Four Bombardier CRJ900 Aircraft19.7.2018 18:36 | Pressmeddelande
First operator of the new CRJ Series ATMOSPHÈRE cabin in Africa MONTREAL, July 18, 2018 (GLOBE NEWSWIRE) -- Bombardier Commercial Aircraft announced today that it has signed a firm order for four new CRJ900 regional jets with Uganda National Airlines Company. Based on the list price for the CRJ900 aircraft, the firm order is valued at approximately US$190 million. "We congratulate the Government of Uganda for the revival of its national flag carrier, and are thrilled that the new airline has selected Bombardier and the CRJ900 regional jets for its upcoming debut," said Jean-Paul Boutibou, Vice President, Sales, Middle-East and Africa, Bombardier Commercial Aircraft. "Recognized for its superior economics and efficiency, the CRJ Series aircraft have enabled airlines worldwide to serve communities with better connectivity, and we look forward to supporting the development of Uganda's regional air travel with these CRJ900 regional jets." Uganda Airlines will operate the CRJ900 in dual-cla
CrownBio Supports Excellence in Translational Research with Grant Award that Funds Innovative PDX Model Development in Immuno-Oncology19.7.2018 15:03 | Pressmeddelande
"Cancer Research Center of Lyon iPS novel PDX models formulate new immune cell focused strategies" SAN DIEGO, July 19, 2018 (GLOBE NEWSWIRE) -- Crown Bioscience, a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, is proud to announce the award of its Patient-Derived Xenograft (PDX) grant program to doctors Fabrice Lavial, Christophe Caux and Bertrand Dubois from the Cancer Research Center of Lyon (CRCL). The grant program was established to support oncology researchers pursuing scientific advancements in cancer using PDX technology. Following an extensive review, CrownBio's Scientific Steering Committee selected Dr. Lavial and his colleagues at the CRCL due to their project's potential to create breakthroughs in preclinical oncology strategies. Their research combines PDX and iPS cell technologies to create patient-specific, humanized models. These unique models wil
I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt pressrum