NASDAQ OMX

Abiomed Receives FDA PMA Approval for Impella RP® for Right Heart Failure

Dela

DANVERS, Mass., Sept.  20, 2017  (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, today announced it has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the Impella RP® heart pump. Culminating from five years of research, this approval follows the prior FDA Humanitarian Device Exemption (HDE) received in January 2015 and adds the Impella RP heart pump to Abiomed's platform of PMA approved devices.

With this approval, the Impella RP heart pump is the only percutaneous temporary ventricular support device that is FDA-approved as safe and effective for right heart failure as stated in the indication:

The Impella RP System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area greater than or equal to 1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

Data submitted to the FDA in support of the Impella RP heart pump PMA included the RECOVER RIGHT1 FDA-approved, prospective, multicenter, single-arm study, which commenced after the company received FDA investigational device exemption (IDE) approval in November 2012 and concluded in 2014. Since that time, Abiomed completed a Continuous Access Protocol (CAP) as well as a prospective, multicenter post-approval study (PAS). These data were presented in the plenary session of the 2017 Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation2. The Impella RP heart pump is reimbursed by Medicare and other major payers. Abiomed will complete a PMA post-approval study with 60 consecutive patients in Abiomed's Institutional Review Board (IRB)-approved, FDA audited prospective cVAD Registry.

Right Ventricular Failure (RVF) is associated with increased mortality, longer lengths of stay in the intensive care unit and potential end-organ dysfunction1. The Impella RP heart pump stabilizes the patient's hemodynamics, unloads the right ventricle and allows for native heart recovery. Delivered through a catheter requiring only a small hole in the leg, the Impella RP heart pump is designed to provide the flow and pressure needed to compensate for right heart failure. The device does not require a surgical procedure for insertion, and it provides more than four liters of blood per minute for hemodynamic support.

"The Impella RP has opened up a new era in cardiovascular medicine. With its percutaneous, single vascular access, the Impella RP offers physicians a minimally-invasive procedure for patients who have previously had limited options for treatment of right heart failure," said Mark B. Anderson, M.D., FASC, co-principle investigator for the RECOVER RIGHT trial and vice chair of cardiac surgery services and cardiothoracic surgeon to the Hackensack University Medical Group. "The cumulative data from the FDA studies demonstrate that Impella RP potentially offers survival benefits for these critically ill patients in need of hemodynamic support."

"This latest PMA approval for Impella RP enables physicians for the first time to percutaneously treat a broader population of patients with right heart failure," said Michael R. Minogue, President, Chairman and CEO of Abiomed. "Abiomed would like to recognize the FDA as well as our physicians, scientists and employees for the extensive clinical research and review that allowed this FDA PMA approval. Abiomed now offers a platform of minimally-invasive devices that support both sides of the heart to enable heart recovery and we are committed to education and training for the entire heart team as we move to full commercial availability."

  1. Anderson MB, Goldstein J, Milano C, et al. Benefits of a novel percutaneous ventricular assist device for right heart failure: The prospective RECOVER RIGHT study of the Impella RP device. J Heart Lung Transplant. 2015; 34(12):1549-1560.
  2. Anderson, MB, et al. Impella RP Post Approval Study: First Multi-Center, Prospective Post Market Approval Results for the Impella RP in Patients with Right Ventricular Failure. J Heart Lung Transplant. 2017; 36(4):S64-S65.

ABOUT IMPELLA HEART PUMPS

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. 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. 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.

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




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

NASDAQ OMX
NASDAQ OMX



Följ NASDAQ OMX

Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från NASDAQ OMX

Winners in 2018 Asia-Pacific Stevie® Awards Announced23.4.2018 04:00Pressmeddelande

Honorees for Innovation in Business to Be Recognized in Hong Kong on 1 June FAIRFAX, Va., April 22, 2018 (GLOBE NEWSWIRE) -- Winners in the fifth annual Asia-Pacific Stevie® Awards, the only awards program to recognize innovation in business throughout the entire Asia-Pacific region, were announced today. The list of Gold, Silver and Bronze Stevie Award winners is available at http://Asia.StevieAwards.com. The Stevie Awards are considered to be the world's premier business awards, conferring recognition for achievement in the workplace over the past 16 years in programs such as The International Business Awards® and The American Business Awards®. The 2018 Asia-Pacific Stevie Awards have recognized organizations in 14 nations including Australia, China, India, Indonesia, Japan, Malaysia, Myanmar, Philippines, Singapore, South Korea, Taiwan, Thailand, the U.S.A. and Vietnam. More than 800 nominations about innovative achievements in the 22-nation APAC region were considered by the judges

Gratomic and Perpetuus Carbon Technologies Limited Enter Into an Agreement for the Exclusive Development and Marketing of Material Enhancing Graphenes Derived From Gratomic Aukam Graphite22.4.2018 22:00Pressmeddelande

TORONTO, April 22, 2018 (GLOBE NEWSWIRE) -- Gratomic Inc. ("GRAT" or the "Company") (TSX-V:GRAT) (FRANKFURT:CB81) (WKN:A2JAP3). Gratomic Inc., is pleased to announce that the Company has signed a letter of collaboration ("Agreement") with Perpetuus Carbon Technologies Limited ("Perpetuus") pursuant to which GRAT and Perpetuus will develop and market material enhancing graphite derived graphenes and graphene hybrids for tire elastomers, whilst also exploring options to exploit polymer composites, energy capture and storage applications markets ("Project"). The Agreement contemplates the first Phase of the Project ("Phase 1"), with the other phases to be described in a joint venture agreement to be entered into between GRAT and Perpetuus. Pursuant to the Agreement, and as part of Phase 1, GRAT will purchase, and retain ownership, of three specialised process tooling chambers at an aggregate cost of 300,000 British Pounds. These specialized tooling chambers will be housed in Perpetuus' ex

Arc Aroma Pure AB : 180420 ARCAROMA stärker informationsflödet till den finansiella marknaden20.4.2018 15:20Pressmeddelande

Pressrelease 2018-04-20 A rc Aroma Pure AB ("ARCAROMA") möter det ökade intresset hos investerare och aktiverar en ny tjänst. ARCAROMA kommer att publicera nyhetsbrev med en mer djuplodande information om bolaget, strategier och framsteg. Skälet är ett kraftigt ökat intresse från marknaden, kanske som resultat av en ägarspridning. Även de restriktioner som numera finns hos marknaden avseende finansiella pressmeddelande spelar in. Det första nyhetsbrevet kommer att släppas under vecka 17 på bolagets Investor sida www.investor.arcaroma.se. På investor.arcaroma.se kommer det att finnas en länk till nyhetsbreven och till en sida där allmänheten har möjlighet att anmäla sig till en prenumerationstjänst. Målsättningen är att nyhetsbreven skall släppas periodiskt och i även samband med händelser som förtjänar en mer detaljerad information än vad som ryms i ett finansiellt pressmeddelande. Det är vår förhoppning att bolaget på detta sätt kan tillfredsställa det ökande behov av information som

Abeona Therapeutics Receives Orphan Drug Designation in the European Union for ABO-202 Gene Therapy Program in Batten Disease20.4.2018 14:15Pressmeddelande

NEW YORK and CLEVELAND, April 20, 2018 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, announced today that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products has granted Orphan Drug Designation (EMA/OD/013/18) for Abeona's gene therapy program ABO-202 for the treatment of subjects with neuronal ceroid lipofuscinosis, also known as Batten Disease, a fatal lysosomal storage disease that primarily affects the nervous system in children. ABO-202 is an adeno-associated virus developed to introduce a functional copy of the CLN1 gene into cells in order to restore the enzyme activity that is needed to break down certain lipopigment proteins that are deficient in patients with CLN1 disease. "This designation is an important step in our CLN1 program as it encourages us to proceed towards clinical development," st

Taconic Biosciences Licenses Easi-CRISPR Technology from the University of Nebraska20.4.2018 14:00Pressmeddelande

RENSSELAER, N.Y., April 20, 2018 (GLOBE NEWSWIRE) -- Taconic Biosciences, a global leader in providing genetically engineered mouse model and service solutions, has been granted a license to the Easi-CRISPR technology from the University of Nebraska. Easi-CRISPR was developed in the laboratories of Drs. Masato Ohtsuka (Tokai University in Japan), and Channabasavaiah Gurumurthy (University of Nebraska). The terms of the agreement include a world-wide, non-exclusive license to the technology, allowing Taconic rights to generate and sell rodent models generated via Easi-CRISPR. When compared to traditional CRISPR, Easi-CRISPR represents a significant advantage, allowing researchers to perform whole genetic insertions versus being limited to point mutations and constitutive knockouts. "Easi-CRISPR is the next progression of the revolutionary CRISPR/Cas technology. Combining the speed of CRISPR with larger genetic insertions allows complex projects typically requiring homologous recombinati

LeoVegas new principal partner for Swedish Open20.4.2018 11:30Pressmeddelande

The LeoVegas Mobile Gaming Group is expanding its sponsoring partnership with the Swedish Open in Båstad by assuming the role as a principal partner for the prestigious tennis tournament. "Last year's successful sponsor partnership with the Swedish Open in Båstad was a strategic effort to profile LeoVegas Sport and our offering in tennis. This venture whet our appetite, and we have therefore chosen to ramp up our sponsorship from Official Partner to become one of the Swedish Open's Principal Partners," comments Gustaf Hagman, Group CEO. Betting on tennis - especially live betting via mobile devices - is one of the gaming categories which in terms of turnover is growing the fastest in most of LeoVegas markets. Live betting puts high demands on technology and is well in line with LeoVegas' ambition to continuously deliver the best mobile gaming experience. Louise Nylén, LeoVegas' Chief Marketing Officer, comments: "Our sponsoring partnership with the Swedish Open in Båstad strengthens ou

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

Besök vårt pressrum