Highest Court in Germany Affirms Strength of Abiomed’s Patents
September 23 2019 - 8:55AM
Business Wire
The highest court in Germany, the Federal Court of Justice,
recently ruled in favor of Abiomed (NASDAQ: ABMD) in a patent
challenge filed by Thoratec in 2015 and validated the strengths of
Abiomed’s Impella-related patents.
These patents are also the subject of a separate patent
infringement action Abiomed filed against Thoratec (acquired by St.
Jude Medical, now Abbott) in 2015 in the District Court in
Düsseldorf for the sales and marketing of HeartMate PHP® in
Germany. That litigation had been stayed pending the recent Federal
Court of Justice’s ruling. Now that the ruling has been favorably
issued, Abiomed will proceed in additional litigation proceedings.
Abiomed intends to vigorously enforce its patents.
The Federal Court of Justice’s ruling follows its November 2018
ruling and another favorable ruling for Abiomed in the European
Patent Office Technical Boards of Appeal on Abiomed’s pigtail
patents and design for insertion. These rulings are now final and
cannot be appealed.
Abiomed has invested more than $500 million and 20 years of
research and development for Impella and owns a robust world-wide
portfolio of 715 patents and 622 patents pending, covering all
aspects of its existing and future products.
ABOUT IMPELLA HEART PUMPS
The Impella 2.5® and Impella CP® devices are U.S. FDA PMA
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. The Impella 2.5, Impella CP, Impella CP with
SmartAssist™, Impella 5.0® and Impella LD® are U.S. 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 RP® is U.S. FDA approved to treat right heart
failure or decompensation following left ventricular assist device
implantation, myocardial infarction, heart transplant, or
open-heart surgery. Impella is the most studied mechanical
circulatory support device in the history of the FDA with real
world clinical data on more than 100,000 patients and more than 550
peer-reviewed publications.
In Europe, the Impella 2.5, Impella CP and Impella CP with
SmartAssist are CE marked for treatment of high-risk PCI and AMI
cardiogenic shock patients for up to 5 days. Impella 5.0 and
Impella LD are CE marked to treat heart attack or cardiomyopathy
patients in cardiogenic shock for up to 10 days. The Impella 5.5™
heart pump is CE marked to treat heart attack or cardiomyopathy
patients in cardiogenic shock for up to 30 days. The Impella RP is
CE marked to treat right heart failure or decompensation following
left ventricular assist device implantation, myocardial infarction,
heart transplant, open-heart surgery, or refractory ventricular
arrhythmia.
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.impella.com.
ABOUT ABIOMED
Based in Danvers, Massachusetts, USA, 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.
Abiomed, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella
CP, Impella RP, and Impella Connect are registered trademarks of
Abiomed, Inc., and are registered in the U.S. and certain foreign
countries. Impella BTR, Impella 5.5, Impella ECP, CVAD Study, and
SmartAssist are pending trademarks of Abiomed, Inc.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190923005467/en/
Tom Langford Director, Communications and Public Relations
978-882-8408 tlangford@abiomed.com
Ingrid Goldberg Ward Director, Investor Relations 978-646-1590
igoldberg@abiomed.com
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