Abiomed

Last updated
Abiomed, Inc.
FormerlyApplied Biomedical Corporation (at founding)
Company type Subsidiary
IndustryMedical devices
Founded1981;43 years ago (1981)
Founder David Lederman
Headquarters Danvers, Massachusetts, U.S.
Key people
Andrew Greenfield (President)
Thorsten Siess (EVP and CTO)
Chuck Simonton (EVP and CMO)
ProductsCardiovascular medical implant devices
RevenueIncrease2.svg US$1.032 billion (2022)
Decrease2.svgUS$140.7 million (2022)
Decrease2.svgUS$136.5 million (2022)
Total assets Decrease2.svgUS$976.5 million (2022)
Total equity Increase2.svgUS$1.503 billion (2022)
Number of employees
2,003 (2022)
Parent Johnson & Johnson (2022–present)
Website abiomed.com
Footnotes /references
[1]

Abiomed, Inc. is a medical device technology company that operates as a stand-alone business within Johnson & Johnson's MedTech Segment. [2] 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, Berlin, Aachen, and Tokyo.

Contents

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. [2] 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". [3]

As of 2022, the company had secured five FDA approvals and 1,408 patents with 1,416 pending. [4] For fiscal year 2022, Abiomed reported $1.032 billion in revenue and reported diluted earnings per share was $2.98 for the year. [1]

On December 22, 2022, Johnson & Johnson completed the acquisition of Abiomed. [5]

History

Abiomed was founded in Danvers, Massachusetts by David M. Lederman in 1981 as Applied Biomedical Corporation. [6] That year, the company commenced the development of an artificial heart. [7] Funded by federal research grants, [8] 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. [6] In July 2001, AbioCor became the first artificial heart successfully implanted in a patient, where it pumped more than 20 million times. [9] Fourteen of the AbioCor devices were implanted, during clinical trials from 2001 to 2004, with the longest-living recipient surviving 512 days. [6] The AbioCor won FDA approval in 2006 for patients who are near death and do not qualify for a heart transplant. [7]

In 2004, Michael R. Minogue became president and CEO of Abiomed. [10] In 2005, Abiomed purchased ventricular assist device company Impella CardioSystems AG of Aachen, Germany, [11] maker of the Impella heart pump, developed by Thorsten Siess, [12] who is now the Chief Technology Officer at Abiomed. [13] [ self-published source ] After Abiomed acquired Impella the company's focus shifted from heart replacement to heart recovery. [14]

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. [15]

In May 2018, Abiomed was added to the S&P 500 index. [16] During the S&P's rise from 2000 to 3000, Abiomed was the index's top performing stock. [17]

In 2018, Abiomed built a $17 million Innovation Center to facilitate research and product development at its headquarters in Danvers. [18] The 29,800-square-foot facility features laboratories for blood, optical, software, mechanical and electrical research, plus a production line. [19]

In 2019, Barron's ranked Abiomed the fourth best stock of the 2010s, with total return of 1,983%. [20] while Fortune ranked Abiomed 19th on the magazine's list of 100 fastest-growing companies. [21]

In April 2020, Abiomed acquired medical device company Breethe, a startup that spun out of the University Of Maryland. [22] 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. [23] The technology, now known as the Abiomed Breethe OXY-1 System, received FDA 510(k) clearance later that year. [24]

In June 2020, Abiomed appointed Charles A. Simonton, MD, as vice president and Chief Medical Officer. [25] 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. [26]

In February and April 2021, Abiomed appointed neurosurgeon Myron Rolle and cardiologist Paula Johnson to the board of directors. [27] Drs. Rolle and Johnson serve on the Governance and Nominating Committee and Regulatory and Compliance Committee of the board. [28] [29]

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. [30]

In November 2022, Abiomed announced that it would be acquired by Johnson & Johnson in a $16.6 billion deal. [31] The deal closed on December 22. [32] Following the acquisition, Abiomed continues to operate as a standalone business within Johnson & Johnson's MedTech segment. [2]

Technology

Impella is the world's smallest heart pump. [16] 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. [14] In 2007, the Impella 2.5 heart pump was among 35 healthcare products to receive a 2007 Medical Design Excellence Award. [33] 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. [34]

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. [24]

Since 2005 when Abiomed acquired the Impella technology, [35] the heart devices have received a series of FDA approvals. [36] 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). [37] In 2016, the Impella RP system became the first percutaneous single-access heart pump designed for right-heart support to receive FDA approval. [38]

There is a lack of data from randomized controlled trials for Impella devices in cardiogenic shock, despite calls from the medical community. [39] 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. [40] This may be partly due to increased risk of bleeding and peripheral vascular complications with the Impella device. [41] 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. [42] 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. [43] The FDA also granted breakthrough device designation for its smallest heart pump, the Impella ECP, which measures only 3mm in length. [44]

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. [45] 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. [46] 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. [47]

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. [2] [7]

See also

Related Research Articles

<span class="mw-page-title-main">Artificial heart</span> Mechanical device which replaces the heart

An artificial heart is an artificial organ device that replaces the heart. Artificial hearts are typically used to bridge the time to complete heart transplantation surgery, but research is ongoing to develop a device that could permanently replace the heart in the case that a heart transplant is unavailable or not viable. As of December 2023, there are two commercially available full artificial heart devices; in both cases, they are for temporary use, of less than a year, for total heart failure patients awaiting a human heart to be transplanted into their bodies.

<span class="mw-page-title-main">Extracorporeal membrane oxygenation</span> Technique of providing both cardiac and respiratory support

Extracorporeal membrane oxygenation (ECMO), is a form of extracorporeal life support, providing prolonged cardiac and respiratory support to persons whose heart and lungs are unable to provide an adequate amount of oxygen, gas exchange or blood supply (perfusion) to sustain life. The technology for ECMO is largely derived from cardiopulmonary bypass, which provides shorter-term support with arrested native circulation. The device used is a membrane oxygenator, also known as an artificial lung.

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 AbioCor ran on a rechargeable source of power. The internal battery was charged by a transcutaneous energy transmission (TET) system, meaning that no wires or tubes penetrated the skin, reducing the risk of infection. However, because of its size, this heart was only compatible with men who had a large frame. It had a product life expectancy of 18 months.

<span class="mw-page-title-main">Cardiogenic shock</span> Medical emergency resulting from inadequate blood flow due to dysfunction of heart ventricles

Cardiogenic shock is a medical emergency resulting from inadequate blood flow to the body's organs due to the dysfunction of the heart. Signs of inadequate blood flow include low urine production, cool arms and legs, and decreased level of consciousness. People may also have a severely low blood pressure and heart rate.

<span class="mw-page-title-main">Ventricular assist device</span> Medical device to assist or replace a heart

A ventricular assist device (VAD) is an electromechanical device that provides support for cardiac circulation, which is used either to partially or to completely replace the function of a failing heart. VADs can be used in patients with acute (sudden onset) or chronic (long standing) heart failure, which can occur due to a variety of reasons (e.g. coronary artery disease, atrial fibrillation, valvular disease, and so forth).

The intra-aortic balloon pump (IABP) is a mechanical device that increases myocardial oxygen perfusion and indirectly increases cardiac output through afterload reduction. It consists of a cylindrical polyurethane balloon that sits in the aorta, approximately 2 centimeters (0.79 in) from the left subclavian artery. The balloon inflates and deflates via counter pulsation, meaning it actively deflates in systole and inflates in diastole. Systolic deflation decreases afterload through a vacuum effect and indirectly increases forward flow from the heart. Diastolic inflation increases blood flow to the coronary arteries via retrograde flow. These actions combine to decrease myocardial oxygen demand and increase myocardial oxygen supply.

<span class="mw-page-title-main">Acute decompensated heart failure</span> Medical condition

Acute decompensated heart failure (ADHF) is a sudden worsening of the signs and symptoms of heart failure, which typically includes difficulty breathing (dyspnea), leg or feet swelling, and fatigue. ADHF is a common and potentially serious cause of acute respiratory distress. The condition is caused by severe congestion of multiple organs by fluid that is inadequately circulated by the failing heart. An attack of decompensation can be caused by underlying medical illness, such as myocardial infarction, an abnormal heart rhythm, infection, or thyroid disease.

A wearable cardioverter defibrillator (WCD) is a non-invasive, external device for patients at risk of sudden cardiac arrest (SCA). It allows physicians time to assess their patient's arrhythmic risk and see if their ejection fraction improves before determining the next steps in patient care. It is a leased device. A summary of the device, its technology and indications was published in 2017 and reviewed by the EHRA Scientific Documents Committee.

The Hemopump was designed to allow for temporary support of a failing heart. It is a continuous flow pump, and does not need to be synced to the rhythm of the heart. It assists in temporary heart stimulation with conditions such as cardiogenic shock following acute myocardial infarction, heart failure from cardiopulmonary bypass, and more. The pump can continually monitor the left ventricle, which allows for perpetual observation of the hearts condition. This allows for any necessary changes to be made when needed. The pump operates at speeds between two hundred and ninety and four hundred and seventy revolutions per minute.

Destination therapy is a therapy that is final rather than being a transitional stage until another therapy—thus, in transportation metaphor, a destination in itself rather than merely a bridge or road to the destination. The term usually refers to ventricular assist devices or mechanical circulatory support to keep the existing heart going, not just until a heart transplant can occur, but for the rest of the patient's life expectancy. It is thus a course of treatment for severe heart failure patients who are not likely candidates for transplant. In contrast, bridge-to-transplant therapy is a way to stay alive long enough, and stay healthy enough, to await transplant while maintaining eligibility for transplant.

Thoratec Corporation is a United States-based company that develops, manufactures, and markets proprietary medical devices used for mechanical circulatory support for the treatment of heart-failure patients worldwide. It is a global leader in mechanical circulatory support devices, particularly in ventricular assist devices (VADs).

<span class="mw-page-title-main">Reperfusion therapy</span> Restoring blood flow post-heart attack

Reperfusion therapy is a medical treatment to restore blood flow, either through or around, blocked arteries, typically after a heart attack. Reperfusion therapy includes drugs and surgery. The drugs are thrombolytics and fibrinolytics used in a process called thrombolysis. Surgeries performed may be minimally-invasive endovascular procedures such as a percutaneous coronary intervention (PCI), which involves coronary angioplasty. The angioplasty uses the insertion of a balloon and/or stents to open up the artery. Other surgeries performed are the more invasive bypass surgeries that graft arteries around blockages.

Myocardial infarction complications may occur immediately following a heart attack, or may need time to develop. After an infarction, an obvious complication is a second infarction, which may occur in the domain of another atherosclerotic coronary artery, or in the same zone if there are any live cells left in the infarct.

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 ECMO and Centrimag.

ReliantHeart, Inc. is a privately held American company headquartered in Houston, Texas that designs, manufactures, and provides remote monitoring capabilities for its left ventricular assist devices which are used to assist circulation for failing hearts.

Berlin Heart GmbH is a German company that develops, produces and markets ventricular assist devices (VADs). The devices mechanically support the hearts of patients with end-stage heart failure. Berlin Heart's products include the implantable INCOR VAD and the paracorporeal EXCOR VAD. To date, Berlin Heart produces the only device of its kind available for babies and children with severe heart failure.

<span class="mw-page-title-main">Protected percutaneous coronary intervention</span>

Protected percutaneous coronary intervention, abbreviated as Protected PCI, is a heart procedure that involves a ventricular assist device that is used to treat patients with cardiovascular disease, including advanced heart failure.

<span class="mw-page-title-main">Acute cardiac unloading</span>

Acute cardiac unloading is any maneuver, therapy, or intervention that decreases the power expenditure of the ventricle and limits the hemodynamic forces that lead to ventricular remodeling after insult or injury to the heart. This technique is being investigated as a therapeutic to aid after damage has occurred to the heart, such as after a heart attack. The theory behind this approach is that by simultaneously limiting the oxygen demand and maximizing oxygen delivery to the heart after damage has occurred, the heart is more fully able to recover. This is primarily achieved by using temporary minimally invasive mechanical circulatory support to supplant the pumping of blood by the heart. Using mechanical support decreases the workload of the heart, or unloads it.

Bridge therapy is therapy intended, in transportation metaphor, to serve as a figurative bridge to another stage of therapy or health, helping a patient past a challenging period caused by particular severe illness. There are various types of bridge therapy, such as bridge to transplant, bridge to candidacy, bridge to decision, bridge to recovery, and anticoagulation bridge. Bridge therapy exists in contrast to destination therapy, which is the figurative destination rather than a bridge to something else.

<span class="mw-page-title-main">David Lederman</span> American aerospace engineer, entrepreneur, author, and humanitarian.

David M. Lederman was an American aerospace engineer, entrepreneur, author, and humanitarian. He is noted for founding Abiomed, the company that developed AbioCor, the first fully implantable artificial heart.

References

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