Abiomed

Abiomed was founded in Danvers, Massachusetts by David M. Lederman in 1981 as Applied Biomedical Corporation.{{Cite news |last=Hevesi |first=Dennis |date=28 August 2012 |title=David Lederman, Pioneer of Artificial Heart, Dies at 68 |newspaper=The New York Times |url=https://www.nytimes.com/2012/08/29/health/research/david-lederman-pioneer-of-artificial-heart-dies-at-68.html |url-access=limited |access-date=3 August 2020}} That year, the company commenced the development of an artificial heart.{{Cite news |last=Altman |first=Lawrence K. |date=6 September 2006 |title=Implantable Heart Device Receives F.D.A. Approval |newspaper=The New York Times |url=https://www.nytimes.com/2006/09/06/health/06heart.html |url-access=limited |access-date=19 July 2016}} Funded by federal research grants,{{Cite web |last=Regalado |first=Antonio |date=1 May 1999 |title=CPR for the Artificial Heart |url=https://www.technologyreview.com/1999/05/01/41520/cpr-for-the-artificial-heart/ |url-access=subscription |url-status=live |archive-url=https://web.archive.org/web/20200808150630/https://www.technologyreview.com/1999/05/01/41520/cpr-for-the-artificial-heart/ |archive-date=8 August 2020 |access-date=19 July 2016 |publisher=MIT Technology Review}} Lederman partnered with The Texas Heart Institute to develop the AbioCor, 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.{{Cite news |last=Altman |first=Lawrence K. |date=12 January 2001 |title=Man With Artificial Heart Dies 5 Months After Implant |newspaper=The New York Times |url=https://www.nytimes.com/2001/12/01/us/man-with-artificial-heart-dies-5-months-after-implant.html |url-access=limited |access-date=19 July 2016}} Fourteen of the AbioCor devices were implanted, during clinical trials 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.{{Cite web |last=Hollmer |first=Mark |date=19 April 2004 |title=New Abiomed chief Minogue looks to pump up sales |url=http://www.bizjournals.com/boston/stories/2004/04/19/story6.html |url-status=live |archive-url=https://web.archive.org/web/20081022024024/http://www.bizjournals.com/boston/stories/2004/04/19/story6.html |archive-date=22 October 2008 |access-date=19 July 2016 |publisher=Boston Business Journal}} In 2005, Abiomed purchased ventricular assist device company Impella CardioSystems AG of Aachen, Germany,{{Cite web |date=27 April 2005 |title=Abiomed to pay $45M to buy Impella CardioSystems |url=http://www.bizjournals.com/boston/stories/2005/04/25/daily44.html |access-date=19 July 2016 |publisher=Boston Business Journal}} maker of the Impella heart pump, developed by Thorsten Siess,{{Cite news |last=Burke |first=Alan |date=20 January 2010 |title=How to mend a broken heart, and make millions |work=The Salem News |url=http://www.salemnews.com/news/business/how-to-mend-a-broken-heart-and-make-millions/article_2ca9ed7a-f2b9-5b68-a47c-f084a18d4047.html |url-status=live |access-date=19 July 2016 |archive-url=https://web.archive.org/web/20221226020846/https://www.salemnews.com/news/business/how-to-mend-a-broken-heart-and-make-millions/article_2ca9ed7a-f2b9-5b68-a47c-f084a18d4047.html |archive-date=26 December 2022}} who is now the chief technology officer at Abiomed.{{Cite web |title=Abiomed Executive Team |url=https://www.abiomed.com/about-us/our-leadership |url-status=live |archive-url=https://web.archive.org/web/20210305011936/https://www.abiomed.com/about-us/our-leadership |archive-date=5 March 2021 |access-date=25 December 2022 |publisher=Abiomed}}{{Self-published inline|date=December 2022|certain=yes}} After Abiomed acquired Impella the company's focus shifted from heart replacement to heart recovery.{{cite web |last=Faulkner |first=Sarah |date=10 October 2017 |title=How Abiomed became a major medical device company |url=https://www.medicaldesignandoutsourcing.com/abiomed-cracked-big-100/ |url-status=live |archive-url=https://web.archive.org/web/20200215063636/https://www.medicaldesignandoutsourcing.com/abiomed-cracked-big-100/ |archive-date=15 February 2020 |access-date=5 August 2020 |website=Medical Design & Outsourcing |issn=2576-5981}}

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.{{Cite web |last=Perriello |first=Brad |date=2 July 2014 |title=Abiomed acquires German heart pump maker ECP |url=https://www.massdevice.com/abiomed-acquires-german-heart-pump-maker-ecp/ |url-status=live |archive-url=https://web.archive.org/web/20220927201724/https://www.massdevice.com/abiomed-acquires-german-heart-pump-maker-ecp/ |archive-date=27 September 2022 |access-date=31 March 2020 |website=+MassDevice |language=en-US}}

In May 2018, Abiomed was added to the S&P 500 index.[https://www.nasdaq.com/articles/abiomed-abmd-to-replace-wyndham-in-the-sp-500-benchmark-2018-05-29 "Abiomed (ABMD) to Replace Wyndham in the S&P 500 Benchmark,"] [https://www.nasdaq.com Nasdaq.com], retrieved August 9, 2020. During the S&P's rise from 2000 to 3000, Abiomed was the index's top performing stock.{{cite news |last1=Osipovich |first1=Alexander |title=Videogames and Two-Day Delivery Powered the S&P's Rise to 3000 |url=https://www.wsj.com/articles/videogames-and-two-day-delivery-powered-the-s-ps-rise-to-3-000-11562788761?mod=searchresults&page=1&pos=1 |access-date=15 August 2020|publisher=The Wall Street Journal |date=10 July 2019}}

In 2018, Abiomed built a $17 million Innovation Center to facilitate research and product development at its headquarters in Danvers.{{Cite web |title=Abiomed opens new Innovation Center in Danvers |url=https://www.salemnews.com/news/local_news/abiomed-opens-new-innovation-center-in-danvers/article_9cd747f4-7c44-5937-856d-18fe5a0fc59c.html |access-date=2023-01-19 |website=Salem News |date=3 August 2018 |language=en}} The 29,800-square-foot facility features laboratories for blood, optical, software, mechanical and electrical research, plus a production line.{{cite web |url=https://www.nshoremag.com/community-news/abiomed-celebrates-opening-of-new-innovation-center-in-danvers/ |title=Abiomed Celebrates Opening of New Innovation Center in Danvers |date=6 August 2018 |website=Northshore Magazine |access-date=13 August 2020}}

In 2019, Barron's ranked Abiomed the fourth best stock of the 2010s, with total return of 1,983%.{{Cite web|url=https://www.barrons.com/articles/the-10-best-stocks-of-the-past-decade-51576628081|title=10 Stocks That Had Better Decades Than Amazon and Google|last=Hough|first=Jack|website=www.barrons.com|language=en-US|access-date=2020-07-27}} while Fortune ranked Abiomed 19th on the magazine's list of 100 fastest-growing companies.{{cite web |url=https://fortune.com/100-fastest-growing-companies/2019/abiomed/ |title=100 Fastest-Growing Companies Rank 19 |website=Fortune |access-date=8 August 2020}}

In April 2020, Abiomed acquired medical device company Breethe, a startup that spun out of the University Of Maryland.{{Cite web |last=Eichensehr |first=Morgan |date=May 5, 2020 |title=Abiomed buys Maryland medical device startup |url=https://www.bizjournals.com/boston/news/2020/05/05/abiomed-buys-maryland-medical-device-startup.html |access-date=2023-01-19 |website=Boston Business Journal}} 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.{{Cite web|url=https://www.medtechdive.com/news/abiomed-buys-artificial-lung-device-for-use-with-impella-potential-covid-1/577052/|title=Abiomed buys artificial lung device for use with Impella, potential COVID 19 patients|last=Rachal|first=Maria|date=2020-04-30|website=MedTechDive|language=en-US|access-date=2020-05-29}} The technology, now known as the Abiomed Breethe OXY-1 System, received FDA 510(k) clearance later that year.{{Cite web |first=Sean|last=Whooley| publisher=MassDevice| url=https://www.massdevice.com/first-patients-treated-with-abiomed-ecmo-tech/ | title=First patients treated with Abiomed ECMO tech | date=December 22, 2020}}

In June 2020, Abiomed appointed Charles A. Simonton, MD, as vice president and Chief Medical Officer.[https://www.massdevice.com/abiomed-appoints-new-chief-medical-officer/ "Abiomed appoints new chief medical officer,"] MassDevice, retrieved 31 August 2022. 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.{{Cite web |first=Bertha|last=Coombs| publisher=CNBC | url=https://www.cnbc.com/2020/08/04/fda-approves-abiomed-heart-pump-to-treat-covid-19-patients.html| title=FDA approves Abiomed heart pump to treat coronavirus patients| date=August 4, 2020}}

In February and April 2021, Abiomed appointed neurosurgeon Myron Rolle and cardiologist Paula Johnson to the board of directors.{{Cite web |title=abmd-ex991_6.htm |url=https://www.sec.gov/Archives/edgar/data/815094/000156459021021593/abmd-ex991_6.htm |access-date=2023-01-19 |website=www.sec.gov}} Drs. Rolle and Johnson serve on the Governance and Nominating Committee and Regulatory and Compliance Committee of the board.[https://www.biospace.com/article/releases/abiomed-announces-appointment-of-dr-myron-rolle-to-board-of-directors/ "Abiomed Announces Appointment of Dr. Myron Rolle to Board of Directors,"] BioSpace, retrieved 8 September 2022.[https://www.biospace.com/article/releases/dr-paula-a-johnson-joins-abiomed-board-of-directors/ "Dr. Paula A. Johnson Joins Abiomed Board of Directors,"] BioSpace, retrieved 8 September 2022.

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.{{cite web|url=https://www.mddionline.com/cardiovascular/abiomed-strengthens-hf-offerings-precardia-acquisition |title=Abiomed Strengthens HF Offerings with PreCardia Acquisition| first=Omar|last=Ford|work=Medical Device and Diagnostic Industry |date=3 June 2021}}

In November 2022, Abiomed announced that it would be acquired by Johnson & Johnson in a $16.6 billion deal.{{Cite news |date=2022-11-01 |title=J&J to buy heart pump maker Abiomed in $16.6 bln deal |language=en |work=Reuters |url=https://www.reuters.com/markets/deals/jj-buy-abiomed-166-bln-deal-2022-11-01/ |access-date=2022-11-01}} The deal closed on December 22.{{Cite web |last=Whooley |first=Sean |date=2022-12-22 |title=Johnson & Johnson completes $16.6B Abiomed acquisition |url=https://www.massdevice.com/johnson-johnson-completes-16-6b-abiomed-acquisition/ |access-date=2022-12-22 |website=MassDevice |language=en-US}} Following the acquisition, Abiomed continues to operate as a standalone business within Johnson & Johnson's MedTech segment.

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.{{Cite web|url=http://www.dicardiology.com/content/abiomed-impella-25-recognized-innovative-design|title=Abiomed Impella 2.5 Recognized for Innovative Design|date=8 April 2007|access-date=2016-07-19}} 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.{{cite news |title=Impella |url=http://www.abiomed.com/impella |work=Abiomed |location=Abiomed.com |access-date=27 September 2022 }}

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,{{cite news |last=Faulkner |first=Sarah |date=October 10, 2017 |title=How Abiomed became a major medical device company |url=https://www.medicaldesignandoutsourcing.com/abiomed-cracked-big-100/ |work=Medical Design & Outsourcing }} the heart devices have received a series of FDA approvals.{{Cite web|url=http://www.klkntv.com/story/31844284/a-mobile-lab-about-heart-pumps-stops-in-lincoln|title=A mobile lab about heart pumps stops in Lincoln|access-date=2016-07-19|archive-date=2016-09-15|archive-url=https://web.archive.org/web/20160915010239/http://www.klkntv.com/story/31844284/a-mobile-lab-about-heart-pumps-stops-in-lincoln|url-status=dead}} 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).{{cite web |url=https://www.medscape.com/viewarticle/886042 |title=FDA Okays Abiomed's Impella Heart Pump for Right Heart Failure |last=Brooks |first=Megan |date=21 September 2017 |website=MedScape|access-date=22 August 2020}} 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, [https://www.nshoremag.com/shop-renew/impella-heart-pump-by-abiomed/ "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.{{Cite journal |last1=Hu |first1=Gene |last2=Habib |first2=Anand R. |last3=Redberg |first3=Rita F. |date=2022-09-01 |title=Intravascular Microaxial Left Ventricular Assist Device for Acute Myocardial Infarction With Cardiogenic Shock—A Call for Evidence of Benefit |url=https://doi.org/10.1001/jamainternmed.2022.2734 |journal=JAMA Internal Medicine |volume=182 |issue=9 |pages=903–905 |doi=10.1001/jamainternmed.2022.2734 |pmid=35849388 |s2cid=250622505 |issn=2168-6106}} 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.{{Cite journal |last1=Schrage |first1=Benedikt |last2=Ibrahim |first2=Karim |last3=Loehn |first3=Tobias |last4=Werner |first4=Nikos |last5=Sinning |first5=Jan-Malte |last6=Pappalardo |first6=Federico |last7=Pieri |first7=Marina |last8=Skurk |first8=Carsten |last9=Lauten |first9=Alexander |last10=Landmesser |first10=Ulf |last11=Westenfeld |first11=Ralf |last12=Horn |first12=Patrick |last13=Pauschinger |first13=Matthias |last14=Eckner |first14=Dennis |last15=Twerenbold |first15=Raphael |date=2019-03-05 |title=Impella Support for Acute Myocardial Infarction Complicated by Cardiogenic Shock: Matched-Pair IABP-SHOCK II Trial 30-Day Mortality Analysis |journal=Circulation |language=en |volume=139 |issue=10 |pages=1249–1258 |doi=10.1161/CIRCULATIONAHA.118.036614 |pmid=30586755 |issn=0009-7322|doi-access=free }} This may be partly due to increased risk of bleeding and peripheral vascular complications with the Impella device.{{Cite journal |last1=Philipson |first1=Daniel J. |last2=Cohen |first2=David J. |last3=Fonarow |first3=Gregg C. |last4=Ziaeian |first4=Boback |date=2021-02-01 |title=Analysis of Adverse Events Related to Impella Usage (from the Manufacturer and User Facility Device Experience and National Inpatient Sample Databases) |journal=The American Journal of Cardiology |volume=140 |pages=91–94 |doi=10.1016/j.amjcard.2020.10.056 |pmid=33147430 |pmc=7796940 |s2cid=226259627 |issn=0002-9149}} 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.{{Cite journal |last1=Miller |first1=P. Elliott |last2=Bromfield |first2=Samantha G. |last3=Ma |first3=Qinli |last4=Crawford |first4=Geoffrey |last5=Whitney |first5=John |last6=DeVries |first6=Andrea |last7=Desai |first7=Nihar R. |date=2022-09-01 |title=Clinical Outcomes and Cost Associated With an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump in Patients Presenting With Acute Myocardial Infarction Complicated by Cardiogenic Shock |url=https://doi.org/10.1001/jamainternmed.2022.2735 |journal=JAMA Internal Medicine |volume=182 |issue=9 |pages=926–933 |doi=10.1001/jamainternmed.2022.2735 |pmid=35849410 |issn=2168-6106|pmc=9295019 }} 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.{{cite web | url=https://www.medicaldevice-network.com/news/abiomed-heart-pump-fda/ | title=Abiomed's heart pump obtains US FDA pre-market approval | date=June 30, 2021}} The FDA also granted breakthrough device designation for its smallest heart pump, the Impella ECP, which measures only 3mm in length.{{cite web | url=https://www.cardiovascularbusiness.com/topics/clinical/interventional-cardiology/worlds-smallest-heart-pump-receives-fdas-breakthrough | title='World's smallest heart pump' receives FDA's breakthrough device designation | date=August 27, 2021}}

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.{{Cite web |first=Danielle|last=Kirsh| publisher=MassDevice| url=https://www.massdevice.com/first-patient-in-the-world-implanted-with-abiomed-impella-btr-heart-pump/| title=Abiomed announces first Impella BTR heart pump implant | date=April 26, 2022}} 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.{{Cite web | publisher=Cardiac Interventions Today | url=https://citoday.com/news/abiomed-impella-supported-pci-in-high-risk-patients-studied-in-restore-ef | title=Abiomed Impella–Supported PCI in High-Risk Patients Studied in Restore EF | date=August 16, 2022}} 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.{{Cite web |first=Michael|last=Walter| publisher=Cardiovascular Business | url=https://cardiovascularbusiness.com/topics/clinical/heart-failure/abiomed-heart-pump-gains-fda-approval-treat-acute-right-heart-failure | title=Abiomed heart pump gains FDA approval to treat acute right heart failure | date=October 31, 2022}}

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.

• Thoratec (St. Jude Medical)

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• {{Official|https://www.abiomed.com}}

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Category:Heart disease organizations

Category:Implants (medicine)

Category:Companies based in Essex County, Massachusetts

Category:Manufacturing companies established in 1981

Category:Medical technology companies of the United States

Category:Companies formerly listed on the Nasdaq

Category:1980s initial public offerings

Category:2022 mergers and acquisitions

Category:Johnson & Johnson subsidiaries