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 with additional offices in
Woburn,
Baltimore
Baltimore ( , locally: or ) is the List of municipalities in Maryland, most populous city in the U.S. state of Maryland, fourth most populous city in the Mid-Atlantic (United States), Mid-Atlantic, and List of United States cities by popula ...
,
Berlin
Berlin ( , ) is the capital and List of cities in Germany by population, largest city of Germany by both area and population. Its 3.7 million inhabitants make it the European Union's List of cities in the European Union by population within ci ...
,
Aachen, and
Tokyo
Tokyo (; ja, 東京, , ), officially the Tokyo Metropolis ( ja, 東京都, label=none, ), is the capital and List of cities in Japan, largest city of Japan. Formerly known as Edo, its metropolitan area () is the most populous in the world, ...
.
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, Johnson & Johnson completed the acquisition of Abiomed.
]
History
Abiomed was founded in Danvers, Massachusetts 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 device that replaces the heart. Artificial hearts are typically used to bridge the time to heart transplantation, or to permanently replace the heart in the case that a heart transplant (from a deceased human or, exper ...
. Funded by federal research grants, Lederman partnered with The Texas Heart Institute
The Texas Heart Institute is an independent, nonprofit organization that is improving cardiovascular health through trailblazing research, thought leadership, education, and patient care to forge a better future for those with cardiovascular diseas ...
to develop the AbioCor
AbioCor was a total artificial heart (TAH) developed by the Massachusetts-based company AbioMed. It was fully implantable within a patient, due to a combination of advances in miniaturization, biosensors, plastics and energy transfer. The AbioC ...
, a grapefruit-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 participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, diet ...
s from 2001 to 2004, with the longest-living recipient surviving 512 days. The AbioCor won FDA approval
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
in 2006 for patients who are near death and do not qualify for a heart transplant
A heart transplant, or a cardiac transplant, is a surgical transplant procedure performed on patients with end-stage heart failure or severe coronary artery disease when other medical or surgical treatments have failed. , the most common procedu ...
.
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 electromechanical device for assisting cardiac circulation, which is used either to partially or to completely replace the function of a failing heart. The function of a VAD differs from that of an artific ...
company Impella CardioSystems AG of Aachen, Germany
Aachen ( ; ; Aachen dialect: ''Oche'' ; French and traditional English: Aix-la-Chapelle; or ''Aquisgranum''; nl, Aken ; Polish: Akwizgran) is, with around 249,000 inhabitants, the 13th-largest city in North Rhine-Westphalia, and the 28th- ...
, maker of the Impella
Impella is a family of medical devices used for temporary ventricular support in patients with depressed heart function. Some versions of the device can provide left heart support during other forms of mechanical circulatory support including EC ...
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 large companies listed on stock exchanges in the United States. It is one of the most commonly followed equity indices. As of D ...
.["Abiomed (ABMD) to Replace Wyndham in the S&P 500 Benchmark,"Nasdaq.com](_blank)
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 or Barrons may refer to:
*Barron's Educational Series, a publisher of books, as well as college entrance exam preparation classes and materials, now an imprint of Kaplan Test Prep
** B.E.S. Publishing, the former owner of Barron's
* ''Barr ...
'' ranked Abiomed the fourth best stock of the 2010s, with total return of 1,983%. while '' Fortune'' 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
Acute decompensated heart failure (ADHF) is a sudden worsening of the signs and symptoms of heart failure, which typically includes difficulty breathing (dyspnea), edema, leg or feet swelling, and Fatigue (medical), fatigue. ADHF is a common and ...
(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
Impella is a family of medical devices used for temporary ventricular support in patients with depressed heart function. Some versions of the device can provide left heart support during other forms of mechanical circulatory support including EC ...
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, 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.
A 2020 study of 21,848 non-emergent, high-risk patients who underwent PCI with percutaneous ventricular assist devices (PVADs), including Impella, demonstrated the PVAD patients had a lower rate of mortality and complications than patients who underwent PCI with IABPs. As of 2020, the Impella heart pump is the most studied mechanical circulatory support device in the history of the FDA with more than 14 years of studies, clinical data on more than 140,000 patients, and more than 650 peer-reviewed publications.
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