GlobeNewswire

Abiomed Announces European Approval (CE Marking) for Impella 5.5(TM) and First Patient Treated at University Heart Center Hamburg

Dela

DANVERS, Mass., April 05, 2018 (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart recovery and support technologies, announced today that the Impella 5.5(TM) heart pump received CE marking1 approval in Europe and the first patient was treated at University Heart Center in Hamburg, Germany. The Impella 5.5 heart pump further enhances Abiomed's product portfolio and provides physicians a 30-day, ambulatory, wean-able, forward flow heart pump.

Under the leadership of Professor Hermann Reichenspurner, MD, PhD, Alexander Bernhardt, MD treated the first patient, who presented with ischemic cardiomyopathy, severe mitral regurgitation and an ejection fraction of 18%. The patient currently remains stable on Impella 5.5 support.

The Impella 5.5 heart pump has the ability to provide peak flows of greater than 6.0 liters per minute. It is designed to be implanted in the axillary artery, avoiding the need for a sternotomy and allowing for patient ambulation. The Impella 5.5 is approved in Europe for up to 30 days of support and can be adjusted to nine power levels that regulate flow to optimize weaning protocols. The Impella 5.5 device includes the new SmartAssist technology with optical sensor, which will enable the integration of clinical data informatics including Left Ventricular Pressure (LVP), End-Diastolic Pressure (EDP) and Cardiac Power Output (CPO) on the Impella console as well as real-time, exact positioning of the Impella device. Over the next fiscal year, Abiomed plans to launch the Impella 5.5 heart pump through a controlled roll-out at German hospitals with established heart recovery protocols. Abiomed will continue to collect data on Impella 5.5 user experience and patient outcomes through our German hospitals submitting clinical data in the global cVAD Registry study.

Data Supporting CE Marking Approval

The data submitted for this CE marking approval included pre-clinical data on the Impella 5.5 and incorporates the clinical experience from over 3,000 patients, most all with axillary implants treated with the Impella 5.0 device. The submission also included an analysis of 68 patients from Abiomed's FDA reviewed cVAD Registry study treated with Impella 5.0® or Impella LD® heart pumps and a literature review of eight papers identifying patients treated with the Impella 5.0. Additionally, Abiomed submitted an analysis of 17 patients enrolled in the RECOVER I prospective, multicenter FDA IDE study.

"The Impella 5.5 device is an easy to implant, minimally-invasive device that provides full cardiac flow and stabilizes the patient by increasing cardiac power output, unloading the left ventricle and perfusing the coronaries and end organs," said Hermann Reichenspurner, MD, PhD, Professor and Chief, Department of Cardiovascular Surgery, University Heart Center Hamburg. "This approval gives our cardiovascular community a new option for effectively treating severely ill patients."

"We are excited about the Impella 5.5 and the impact of fully unloading the left ventricle," said Michael R. Minogue, President, Chairman and Chief Executive Officer of Abiomed. "We commend the dedication of the team at University Heart Center Hamburg. The addition of the Impella 5.5 to the Impella platform of devices will further address the clinical needs of patients and physicians as we advance the field of heart recovery."

  1. The CE marking approval for Impella 5.5 intended use is: 
    The Impella 5.5 heart pump is an intracardiac pump for supporting the left ventricle. It is intended for clinical use in cardiology and in cardiac surgery for up to 30 days for the following indications, as well as others: The Impella 5.5 is a cardiovascular support system for patients with reduced left ventricular function, e.g., post-cardiotomy, low output syndrome, cardiogenic shock after acute myocardial infarction; The Impella 5.5 may also be used as a cardiovascular support system during coronary bypass surgery on the beating heart, particularly in patients with limited preoperative ejection fraction with a high risk of postoperative low output syndrome.

ABOUT IMPELLA HEART PUMPS

The Impella 5.5 heart pump is not approved for use or sale in the United States.

The Impella 2.5®, Impella CP®, Impella CP® with SmartAssist, Impella 5.0® and Impella LD® are FDA-approved heart pumps used to treat heart attack or cardiomyopathy 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 FDA approved to treat patients experiencing acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. 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.

ABOUT ABIOMED 
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.

FORWARD-LOOKING STATEMENTS

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.

**For further information please contact: 
Ingrid Goldberg Ward
Director, Investor Relations
978-646-1590
igoldberg@abiomed.com




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 originality of the information contained therein.
Source: Abiomed via Globenewswire

Om

GlobeNewswire



Följ GlobeNewswire

Abonnera på våra pressmeddelanden. Endast mejladress behövs och den används bara här. Du kan avanmäla dig när som helst.

Senaste pressmeddelandena från GlobeNewswire

Karolinska Development delays publication of its Annual Report for 2018 and changes date for the Annual General Meeting26.4.2019 08:00:00 CESTPressmeddelande

STOCKHOLM, SWEDEN - 26 April 2019. Karolinska Development AB (Nasdaq Stockholm: KDEV) announces today that The Board of Directors has decided to delay the publication of its Annual Report for 2018. Karolinska Development has changed the date for the Annual General Meeting to June 26, 2019. The date for publication of the Annual Report for 2018 has been changed from April 26 to April 30, 2019. Karolinska Development has changed the date for the Annual General Meeting from June 4 to June 26, 2019. Notice to the Annual General Meeting will be published in a separate press release. For more information, please contact: Viktor Drvota, CEO, Karolinska Development AB Phone: +46 73 982 52 02, e-mail: viktor.drvota@karolinskadevelopment.com Fredrik Järrsten, CFO, Karolinska Development AB Phone: +46 70 496 46 28, e-mail: fredrik.jarrsten@karolinskadevelopment.com TO THE EDITORS About Karolinska Development AB Karolinska Development AB (Nasdaq Stockholm: KDEV) is a Nordic life sciences investmen

Karolinska Development senarelägger publicering av årsredovisningen för 2018 och meddelar nytt datum för årsstämma26.4.2019 08:00:00 CESTPressmeddelande

STOCKHOLM, SVERIGE - 26 april 2019. Karolinska Development AB (Nasdaq Stockholm: KDEV) meddelar idag att styrelsen har beslutat att senarelägga publiceringen av årsredovisningen för 2018. Karolinska Development har ändrat datum för årsstämman till den 26 juni 2019. Publiceringen av årsredovisningen för 2018 flyttas från den 26 april till den 30 april 2019. Karolinska Development har ändrat datum för årsstämman från den 4 juni till den 26 juni 2019. Kallelse till årsstämman kommer att publiceras senare i ett separat pressmeddelande. För ytterligare information, vänligen kontakta: Viktor Drvota, vd, Karolinska Development AB Tel: +46 73 982 52 02, e-mail: viktor.drvota@karolinskadevelopment.com Fredrik Järrsten, finanschef, Karolinska Development AB Tel: +46 70 496 46 28, e-mail: fredrik.jarrsten@karolinskadevelopment.com TILL REDAKTÖRERNA Om Karolinska Development AB Karolinska Development AB (Nasdaq Stockholm: KDEV) är ett nordiskt investmentbolag inom life science. Bolaget fokuserar p

Karolinska Developments portföljbolag Aprea Therapeutics har fått särläkemedelsstatus och snabbspårstatus från FDA för APR-24616.4.2019 12:46:00 CESTPressmeddelande

STOCKHOLM, SVERIGE - 16 april 2019. Karolinska Development AB meddelar idag att portföljbolaget Aprea Therapeutics har av FDA fått särläkemedelsstatus för APR-246 för behandling av patienter med TP53-muterad myelodysplastiskt syndrom (MDS). Dessutom ger FDA bolaget snabbspårstatus (Fast Track Designation), för APR-246 för behandling av MDS. Amerikanska läkemedelsverket, FDA, ger särläkemedelsstatus till läkemedelskandidater för att snabba på utvärderingen och utvecklingen av säkra och effektiva behandlingar av ovanliga sjukdomar. Särläkemedelsstatus ger företag både regulatoriska och kommersiella incitament genom att läkemedlet får marknadsexklusivitet på den amerikanska marknaden i sju år efter marknadsgodkännande samtidigt som företaget får stöd från FDA när det gäller designen av kliniska prövningar, skatteförmåner för kostnader kopplade till kliniska prövningar och avgiftsbefrielse från FDA. FDA:s snabbspår underlättar utvecklingen av läkemedel som är avsedda för att behandla allva

Karolinska Development's portfolio company Aprea Therapeutics has received FDA Orphan Drug Designation and Fast Track Designation for APR-24616.4.2019 12:46:00 CESTPressmeddelande

STOCKHOLM, April 16, 2019. Karolinska Development's portfolio company Aprea Therapeutics has from FDA received an Orphan Drug Designation for APR-246 for the treatment of patients with Myelodysplastic Syndromes (MDS) having a TP53 mutation. In addition, FDA has also granted Fast Track Designation to APR-246 for treatment of MDS. Orphan Drug Designation is granted by the FDA Office of Orphan Products Development to advance the evaluation and development of safe and effective therapies for the treatment of rare diseases. The designation can provide development and commercial incentives for designated compounds and medicines, including eligibility for a seven-year period of market exclusivity in the U.S. after product approval, FDA assistance in clinical trial design, tax credits related to clinical trial expenses, and an exemption from FDA user fees. The FDA's Fast Track program facilitates the development of drugs intended to treat serious conditions and that have the potential to addre

Bergman & Beving AB: Bergman & Beving förvärvar KGC10.4.2019 14:00:00 CESTPressmeddelande

Pressmeddelande Bergman & Beving förvärvar KGC Bergman & Beving har idag tecknat avtal om förvärv av samtliga aktier i KGC Verktyg & Maskiner AB. KGC, med säte i Älvsjö, har i mer än 60 år utvecklat och levererat kvalitetsverktyg och tillbehör för murning och plattsättning i det egna varumärket KGC. Bolaget omsätter cirka 80 MSEK per år, och har 24 anställda. "KGC är ett ledande varumärke med högt anseende hos murare och plattsättare och har en mycket stark ställning på den svenska marknaden", säger Pontus Boman, VD och koncernchef. Tillträde beräknas ske den 1 maj 2019 och förvärvet bedöms ha en marginellt positiv påverkan på Bergman & Bevings resultat per aktie under innevarande räkenskapsår. Stockholm den 10 april 2019 Bergman & Beving AB (publ) För ytterligare information kontakta: Pontus Boman, VD & Koncernchef, telefon 010-454 77 00 Peter Schön, CFO, telefon 070-339 89 99 Denna information lämnades, genom ovanstående kontaktpersoners försorg, för offentliggörande den 10 april 201

Bergman & Beving AB: Bergman & Beving acquires KGC10.4.2019 14:00:00 CESTPressmeddelande

Press release Bergman & Beving acquires KGC Bergman & Beving has today signed an agreement to acquire all shares in KGC Verktyg & Maskiner AB. KGC, based in Älvsjö, has for more than 60 years developed and delivered quality tools and accessories for bricklayers and tilers in its own brand KGC. The business has a turnover of approximately SEK 80 million per year, and has 24 employees. "KGC is a leading brand with high reputation among bricklayers and tilers and has a very strong position in the Swedish market," says Pontus Boman, President and CEO. The closing is taking effect on 1 May 2019 and the acquisition is expected to have a marginal positive impact on Bergman & Beving's earnings per share during the current fiscal year. Stockholm, 10 April 2019 Bergman & Beving AB (publ) For further information, please contact: Pontus Boman, President & CEO, Tel: +46 10 454 77 00 Peter Schön, CFO, Tel: +46 70 339 89 99 The information was submitted for publication, through the agency of the cont

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum