GlobeNewswire

Abiomed Announces First Patient Enrolled in STEMI DTU Feasibility Study

Dela

DANVERS, Mass., May 04, 2017 (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support technologies, announced today the enrollment of the first patient in the Food and Drug Administration (FDA) approved prospective feasibility study, STEMI Door to Unloading (DTU) with Impella CP® system in acute myocardial infarction. This trial will focus on feasibility and safety of unloading the left ventricle using the Impella CP heart pump prior to primary percutaneous coronary intervention (PCI) in patients presenting with ST segment elevation myocardial infarction (STEMI) without cardiogenic shock with the hypothesis that this will potentially reduce infarct size.

The study, which received FDA approval in October 2016, is a prospective, multi-center feasibility study led by principal investigators Dr. Navin K. Kapur of Tufts Medical Center and Dr. William W. O'Neill of Henry Ford Medical Center. Up to 50 patients at 10 sites will be enrolled in the study, which is expected to be completed within 18 months.

The first patient in the study was enrolled in late April at Northwell Health System in Long Island, NY under the leadership of Dr. Perwaiz Meraj.

The primary endpoints of the feasibility study will focus on safety, including Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 days. All patients will undergo cardiac magnetic resonance (CMR) imaging to assess infarct size as percent of left ventricular mass at 30 days post-PCI. Patients will be randomized to Impella CP placement with immediate primary PCI, or to Impella CP placement with 30 minutes of unloading prior to primary PCI. The hypothesis of this novel approach to treating STEMI patients, based on extensive mechanistic research, is that unloading the left ventricle prior to PCI reduces myocardial work load, oxygen demand and also initiates a cardio-protective effect at the myocardial cell level, which may alleviate myocardial damage caused by reperfusion injury at the time of revascularization. This feasibility study will help refine the protocol and lay the groundwork for a future pivotal study with more sites, patients and will be designed for statistical significance. Abiomed does not plan to announce additional enrollment status.

The ABIOMED logo, ABIOMED, Impella, Impella 2.5, Impella CP, Impella 5.0, Impella RP, and Recovering Hearts. Saving Lives. are registered trademarks of ABIOMED, Inc. in the U.S. and in certain foreign countries. cVAD Registry is a trademark of ABIOMED, Inc.
                        
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
Director, Investor Relations
978-646-1590
igoldberg@abiomed.com

Adrienne Smith
Senior Director, Public Relations and Corporate Communications
978-646-1553
adsmith@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.

Senaste pressmeddelandena från GlobeNewswire

Immunicum AB (publ) Presents Preclinical Results of Ilixadencel in Combination with Checkpoint Inhibitors and Immune Enhancers at ESMO 201822.10.2018 12:45Pressmeddelande

Press Release 22 October 2018 Immunicum AB (publ) Presents Preclinical Results of Ilixadencel in Combination with Checkpoint Inhibitors and Immune Enhancers at ESMO 2018 -- Intratumoral treatment with ilixadencel, an off-the-shelf cell-based immune primer, provides synergistic anti-tumor effect and enhances efficacy of anti-PD-1 and anti-CD137 treatment in animal model -- Immunicum AB (publ; IMMU.ST) announced today the presentation of preclinical results that showed anti-tumor synergy between its lead product ilixadencel and a checkpoint inhibitor or an immune enhancer in a poster at the European Society for Medical Oncology (ESMO) 2018 Congress. The results of the study highlight the ability of intratumoral ilixadencel to enhance anti-tumor response and survival of systemic checkpoint inhibitors (anti-PD-1) or immune enhancers (anti-CD137/4-1BB). This emphasizes the potential for ilixadencel in multiple future immuno-oncology combination strategies by incorporating complementary mech

Immunicum AB (publ) presenterar prekliniska resultat för ilixadencel i kombination med checkpointhämmare och immunaktiverare på 2018 års ESMO-kongress22.10.2018 12:45Pressmeddelande

Pressmeddelande 22 oktober 2018 Immunicum AB (publ) presenterar prekliniska resultat för ilixadencel i kombination med checkpointhämmare och immunaktiverare på 2018 års ESMO-kongress -- Intratumoral behandling med ilixadencel, en cellbaserad, lagringsbar immunaktiverare, ger en synergistisk antitumöreffekt och förstärker effekten av behandling med anti-PD-1 och anti-CD137 i djurmodeller -- Immunicum AB (publ; IMMU.ST) presenterar under 2018 års ESMO kongress (European Society for Medical Oncology) prekliniska resultat som visar en synergistisk anti-tumöreffekt när bolagets ledande produkt ilixadencel ges i kombination med en checkpointhämmare eller immunaktiverare. Resultaten från studien, som presenteras på en poster, visar att intratumoralt administrerat ilixadencel kan förstärka anti-tumörsvar och överlevnad vid behandling med checkpointhämmare eller immunaktiverare. Detta visar på potentialen hos ilixadencel att bli en komplementerande verkningsmekanism till flera olika framtida im

Karolinska Development's portfolio company OssDsign announces FDA clearance for Cranioplug22.10.2018 09:00Pressmeddelande

STOCKHOLM, October 22, 2018. Karolinska Development's portfolio company OssDsign announces that its latest product Cranioplug has received 510(k) clearance by the FDA, which allows marketing and sales of the product in US. The implant is the first product of its kind in the US market. Cranioplug is an implant used during neurosurgical procedures. The product is intended to cover and plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. Cranioplug resorbs and is replaced with bone during the healing process. Anders Lundqvist, CEO of OssDsign, said: "Receiving clearance for Cranioplug is an important step for OssDsign. This motivates us to increase our presence in the US market and continue to build our US organization throughout 2018 and beyond. The regenerative features of OssDsign's calcium phosphate composition are now getting recognized, and it's our mission to turn them into real benefits for patients, surgeons and hospital systems."

Karolinska Development's portfolio company OssDsign announces FDA clearance for Cranioplug22.10.2018 09:00Pressmeddelande

STOCKHOLM, October 22, 2018. Karolinska Development's portfolio company OssDsign announces that its latest product Cranioplug has received 510(k) clearance by the FDA, which allows marketing and sales of the product in US. The implant is the first product of its kind in the US market. Cranioplug is an implant used during neurosurgical procedures. The product is intended to cover and plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. Cranioplug resorbs and is replaced with bone during the healing process. Anders Lundqvist, CEO of OssDsign, said: "Receiving clearance for Cranioplug is an important step for OssDsign. This motivates us to increase our presence in the US market and continue to build our US organization throughout 2018 and beyond. The regenerative features of OssDsign's calcium phosphate composition are now getting recognized, and it's our mission to turn them into real benefits for patients, surgeons and hospital systems."

Karolinska Development's portfolio company Pharmanest changes name and signs licensing agreement15.10.2018 13:25Pressmeddelande

STOCKHOLM, October 15, 2018. Karolinska Development's portfolio company Phamanest changes its name to Palette Life Sciences. The company also announces a global licensing agreement with Nestlé Skin Health. Palette Life Sciences (former Pharmanest) has announced a licensing agreement with Nestlé Skin Health. The agreement gives Palette Life Sciences the worldwide commercialization and development rights for three products: Deflux®, Solesta® and BarrigelTM. The products are all based on the NASHATM (Non Animal Stabilized Hyaluronic Acid) technology. Palette Life Sciences will focus immediately on sales of Deflux and Solesta and will begin preparing for worldwide commercialization of Barrigel. Nestlé Skin Health will continue to manufacture the products on behalf of Palette Life Sciences. Palette Life Science will continue the development of SHACT under the name LidbreeTM. Lidbree will be submitted for European regulatory review later this year. Karolinska Development is a passive investo

Karolinska Development's portfolio company Pharmanest changes name and signs licensing agreement15.10.2018 13:25Pressmeddelande

STOCKHOLM, October 15, 2018. Karolinska Development's portfolio company Phamanest changes its name to Palette Life Sciences. The company also announces a global licensing agreement with Nestlé Skin Health. Palette Life Sciences (former Pharmanest) has announced a licensing agreement with Nestlé Skin Health. The agreement gives Palette Life Sciences the worldwide commercialization and development rights for three products: Deflux®, Solesta® and BarrigelTM. The products are all based on the NASHATM (Non Animal Stabilized Hyaluronic Acid) technology. Palette Life Sciences will focus immediately on sales of Deflux and Solesta and will begin preparing for worldwide commercialization of Barrigel. Nestlé Skin Health will continue to manufacture the products on behalf of Palette Life Sciences. Palette Life Science will continue the development of SHACT under the name LidbreeTM. Lidbree will be submitted for European regulatory review later this year. Karolinska Development is a passive investo

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

Besök vårt pressrum