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Abiomed, Inc. is a
medical device A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
technology company that operates as a stand-alone business within Johnson & Johnson's MedTech Segment. Abiomed develops and manufactures temporary external and implantable mechanical circulatory support devices. The company is headquartered in
Danvers, Massachusetts Danvers is a New England town, town in Essex County, Massachusetts, United States, located on the Danvers River near the northeastern coast of Massachusetts. The suburb is a fairly short ride from Boston and is also in close proximity to the beach ...
with additional offices in Woburn,
Baltimore Baltimore is the most populous city in the U.S. state of Maryland. With a population of 585,708 at the 2020 census and estimated at 568,271 in 2024, it is the 30th-most populous U.S. city. The Baltimore metropolitan area is the 20th-large ...
,
Berlin Berlin ( ; ) is the Capital of Germany, capital and largest city of Germany, by both area and List of cities in Germany by population, population. With 3.7 million inhabitants, it has the List of cities in the European Union by population withi ...
,
Aachen Aachen is the List of cities in North Rhine-Westphalia by population, 13th-largest city in North Rhine-Westphalia and the List of cities in Germany by population, 27th-largest city of Germany, with around 261,000 inhabitants. Aachen is locat ...
, and
Tokyo Tokyo, officially the Tokyo Metropolis, is the capital of Japan, capital and List of cities in Japan, most populous city in Japan. With a population of over 14 million in the city proper in 2023, it is List of largest cities, one of the most ...
. Andrew Greenfield is President of the company, with Dr. Thorsten Siess as Executive Vice President and Chief Technology Officer and Dr. Chuck Simonton as Executive Vice President and Chief Medical Officer. According to Bloomberg, the company "engages in the research, development, and sale of medical devices to assist or replace the pumping function of the failing heart. It also provides continuum of care to heart failure patients". As of 2022, the company had secured five FDA approvals and 1,408 patents with 1,416 pending. For fiscal year 2022, Abiomed reported $1.032 billion in revenue and reported diluted earnings per share was $2.98 for the year. On December 22, 2022,
Johnson & Johnson Johnson & Johnson (J&J) is an American multinational pharmaceutical, biotechnology, and medical technologies corporation headquartered in New Brunswick, New Jersey, and publicly traded on the New York Stock Exchange. Its common stock is a c ...
completed the acquisition of Abiomed.


History

Abiomed was founded in
Danvers, Massachusetts Danvers is a New England town, town in Essex County, Massachusetts, United States, located on the Danvers River near the northeastern coast of Massachusetts. The suburb is a fairly short ride from Boston and is also in close proximity to the beach ...
by David M. Lederman in 1981 as Applied Biomedical Corporation. That year, the company commenced the development of an
artificial heart An artificial heart is a artificial organ, device that replaces the human heart, heart. Artificial hearts are typically used as a bridge to heart transplantation, but ongoing research aims to develop a device that could permanently replace the ...
. Funded by federal research grants, Lederman partnered with The Texas Heart Institute to develop the AbioCor, a
grapefruit The grapefruit (''Citrus'' × ''paradisi'') is a subtropical citrus tree known for its relatively large, sour to semi-sweet, somewhat bitter fruit. The flesh of the fruit is segmented and varies in color from pale yellow to dark red. Grapefru ...
-sized electromagnetic device with an internal battery that completely replaces the heart without wires or tubes passing through the skin. In July 2001, AbioCor became the first artificial heart successfully implanted in a patient, where it pumped more than 20 million times. Fourteen of the AbioCor devices were implanted, during
clinical trial Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...
s from 2001 to 2004, with the longest-living recipient surviving 512 days. The AbioCor won FDA approval in 2006 for patients who are near death and do not qualify for a heart transplant. In 2004, Michael R. Minogue became president and CEO of Abiomed. In 2005, Abiomed purchased
ventricular assist device A ventricular assist device (VAD) is an electromechanics, electromechanical device that provides support for cardiac pump function, which is used either to partially or to completely replace the function of a failing heart. VADs can be used in p ...
company Impella CardioSystems AG of Aachen, Germany, maker of the Impella heart pump, developed by Thorsten Siess, who is now the chief technology officer at Abiomed. After Abiomed acquired Impella the company's focus shifted from heart replacement to heart recovery. In July 2014, Abiomed acquired German heart pump maker ECP in a deal worth up to $30 million. The deal included a nearly $2.8 million buyout of AIS GmbH Aachen Innovative Solutions, which owns some of the patents licensed to ECP. In May 2018, Abiomed was added to the
S&P 500 index The Standard and Poor's 500, or simply the S&P 500, is a stock market index tracking the stock performance of 500 leading companies listed on stock exchanges in the United States. It is one of the most commonly followed equity indices and in ...
."Abiomed (ABMD) to Replace Wyndham in the S&P 500 Benchmark,"Nasdaq.com
retrieved August 9, 2020.
During the S&P's rise from 2000 to 3000, Abiomed was the index's top performing stock. In 2018, Abiomed built a $17 million Innovation Center to facilitate research and product development at its headquarters in Danvers. The 29,800-square-foot facility features laboratories for blood, optical, software, mechanical and electrical research, plus a production line. In 2019, ''
Barron's ''Barron's'' (stylized in all caps) is an American weekly magazine and newspaper published by Dow Jones & Company, a division of News Corp, since 1921. Founded as ''Barron's National Financial Weekly'' in 1921 by Clarence W. Barron (1855–19 ...
'' ranked Abiomed the fourth best
stock Stocks (also capital stock, or sometimes interchangeably, shares) consist of all the Share (finance), shares by which ownership of a corporation or company is divided. A single share of the stock means fractional ownership of the corporatio ...
of the 2010s, with total return of 1,983%. while ''
Fortune Fortune may refer to: General * Fortuna or Fortune, the Roman goddess of luck * Luck * Wealth * Fate * Fortune, a prediction made in fortune-telling * Fortune, in a fortune cookie Arts and entertainment Film and television * ''The Fortune'' (19 ...
'' ranked Abiomed 19th on the magazine's list of 100 fastest-growing companies. In April 2020, Abiomed acquired medical device company Breethe, a startup that spun out of the University Of Maryland. The startup had developed a portable extracorporeal membrane oxygenation (ECMO) system that acts like an artificial lung, oxygenating and removing carbon dioxide from the blood of a patient in cardiogenic shock or respiratory failure. The technology, now known as the Abiomed Breethe OXY-1 System, received FDA 510(k) clearance later that year. In June 2020, Abiomed appointed Charles A. Simonton, MD, as vice president and Chief Medical Officer. Also in 2020, the FDA granted Emergency Use Authorization for the Impella heart pump to stabilize COVID-19 patients following the removal of pulmonary blood clots, as well as the use of the Impella in combination with the Breethe extracorporeal membrane oxygenation (ECMO) system, which pumps more oxygen into the bloodstream. In February and April 2021, Abiomed appointed neurosurgeon Myron Rolle and cardiologist Paula Johnson to the board of directors. Drs. Rolle and Johnson serve on the Governance and Nominating Committee and Regulatory and Compliance Committee of the board. In June 2021, Abiomed acquired preCARDIA, a catheter developer whose system allows for a less-invasive option when treating acute decompensated heart failure (ADHF) patients. In November 2022, Abiomed announced that it would be acquired by Johnson & Johnson in a $16.6 billion deal. The deal closed on December 22. Following the acquisition, Abiomed continues to operate as a standalone business within Johnson & Johnson's MedTech segment.


Technology

Impella is the world's smallest heart pump. It sits in the heart, spinning up to 50,000 revolutions per minute, sending blood throughout the body, allowing the heart to rest and recover. It is inserted through a minimally invasive procedure and guided through an artery to the heart. In 2007, the Impella 2.5 heart pump was among 35 healthcare products to receive a 2007 Medical Design Excellence Award. As of 2022, the Impella heart pump products include the Impella 2.5, Impella 5.0, Impella CP with SmartAssist, Impella 5.5 with SmartAssist, Impella RP with SmartAssist and Impella Connect, which gives providers 24/7 secure access to Impella status data in the cloud for Impella-supported patients. The Abiomed Breethe OXY-1 System is an extracorporeal membrane oxygenation (ECMO) system that pumps, oxygenates and removes carbon dioxide from blood of patients suffering from cardiogenic shock or respiratory failure due to ARDS, H1N1, SARS and COVID-19 among other causes. It can be used alone or in conjunction with the Impella heart pump. Since 2005 when Abiomed acquired the Impella technology, the heart devices have received a series of FDA approvals. Notably, in 2015, Abiomed received FDA approval to use the Impella 2.5 heart pump during elective and urgent high-risk percutaneous coronary intervention procedures. The FDA approval was based on the PROTECT II randomized controlled trial, which found high-risk percutaneous coronary intervention (PCI) patients who underwent PCI with Impella had fewer major adverse events at 90 days (although statistically non-significant), compared to patients who underwent PCI with the intra-aortic balloon pump (IABP). In 2016, the Impella RP system became the first percutaneous single-access heart pump designed for right-heart support to receive FDA approval.Alexandra Pecci
"Impella Heart Pump by Abiomed,"
''Northshore Magazine'', February 25, 2016.
There is a lack of data from randomized controlled trials for Impella devices in cardiogenic shock, despite calls from the medical community. While early studies suggested short term benefits, propensity-matched analyses comparing the Impella device with intra-aortic balloon pump (IABP) showed no benefit for clinically relevant outcomes such as mortality. This may be partly due to increased risk of bleeding and peripheral vascular complications with the Impella device. Some studies have even suggested an increased risk of mortality with Impella devices, compared to the intra-aortic balloon pump (IABP), with an additional expense of >$50,000 at 30 days. There are currently no adequately powered randomized controlled trials of the Impella device for clinically relevant outcomes such as mortality. In 2021, the FDA granted pre-market approval to the Impella RP with SmartAssist, a first single-access, dual-sensor technology device to provide temporary percutaneous ventricular support for patients with acute right heart failure or decompensation after implanting a left ventricular assist device, myocardial infarction, heart transplant or open-heart surgery. The FDA also granted breakthrough device designation for its smallest heart pump, the Impella ECP, which measures only 3mm in length. In April 2022, Abiomed's Impella Bridge-to-Recovery (BTR) minimally-invasive heart pump was successfully implanted in the first patient treated with the device as part of an early feasibility study. In August 2022, results from the Restore EF study were published in ''The Journal of the Society of Cardiovascular Angiography and Interventions''. The study demonstrated that Impella-supported high-risk percutaneous coronary intervention (PCI) led to significant improvements in left ventricular ejection fraction (LVEF), angina symptoms, and heart failure symptoms at the 90-day follow-up. In October 2022, the FDA granted pre-market approval to the Impella RP Flex with SmartAssist for treatment of acute right heart failure for up to 14 days.


Leadership

Andrew Greenfield is Abiomed's President since the company was acquired by Johnson & Johnson in December 2022. He succeeded Michael R. Minogue who retired after serving as chairman, President and CEO since 2004 when Abiomed's founder, David Lederman, had stepped down.


See also

* Thoratec ( St. Jude Medical)


References


External links

* {{DEFAULTSORT:Abiomed Heart disease organizations Implants (medicine) Companies based in Essex County, Massachusetts Manufacturing companies established in 1981 Medical technology companies of the United States Companies formerly listed on the Nasdaq 1980s initial public offerings 2022 mergers and acquisitions Johnson & Johnson subsidiaries