07.20.22
Rank: #2 (Last year: #3)
$30.01 Billion ($43.1B total)
Prior Fiscal: $22.59 Billion
Percentage Change: +32.8%
R&D Expenditure: $2.7B
Best FY21 Quarter: Q4 $8.22B
Latest Quarter: Q1 $8.85B
No. of Employees: 113,000 (total)
Global Headquarters: Abbott Park, Ill.
KEY EXECUTIVES:
Robert B. Ford, Chairman and CEO
Robert E. Funck Jr., Exec. VP and CFO
John M. Capek, Ph.D., Exec. VP, Ventures
Lisa D. Earnhardt, Exec. VP, Medical Devices
John F. Ginascol, Exec. VP, Core Diagnostics
Andrea F. Wainer, Exec. VP, Rapid and Molecular Diagnostics
Abbott Labs has reached the Top 30’s runner-up spot for the first time, and it’s predominantly thanks to the company’s innovation in response to the dire need for quick and accurate diagnostic testing for COVID-19.
Abbott began the year by fulfilling the U.S. federal government’s order of 150 million BinaxNOW COVID-19 Ag tests. The 15-minute, credit card-sized tests were distributed through the U.S. Department of Health and Human Services (HHS) to states, territories, and targeted entities, such as nursing homes, assisted living facilities, home health and hospice agencies, historically black colleges and universities (HBCUs), and the Indian Health Service. Two months later, the at-home version of the test earned emergency use authorization for asymptomatic, non-prescription, over-the-counter self-use. Abbott began shipping the self-tests to retailers a month later.
“Let’s not back down on testing, let’s double down on it,” Thomas Quinn, M.D., professor of medicine and pathology at the Johns Hopkins School of Medicine, told the press. “As long as COVID remains unpredictable, there’s an important role for the corner pharmacy and the central lab to tackle this virus in tandem, which gives this country the best chance to detect and screen for COVID-19.”
The Panbio COVID-19 Ag Rapid Test Device earned CE mark approval for asymptomatic screening and self-administered sample collection with a nasal swab last January as well. The test also delivers results as early as 15 minutes with no instrumentation. The self-test version of the Panbio COVID-19 test earned a CE mark last June, allowing it to be sold directly to consumers with or without symptoms.
ANALYST INSIGHTS: Abbott was on fire in Q1 2022 with growth across their various business units, but then crashed and burned in Q2 due to their now infamous challenges to produce infant formula. While they may be still making money, they have a lot of work to do to enhance their image with the American public and the FDA. I’m guessing Abbott is up to the challenge and the company will be once again rising to the occasion in 2023. Rearview mirror can’t come fast enough for CEO Robert Ford.
Last March saw FDA emergency use authorization for the company’s Alinity m Resp-4-Plex molecular assay to detect and differentiate SARS-CoV-2, influenza A, influenza B, and respiratory syntactical virus (RSV) in one test. The test can be conducted via either one swab specimen (anterior nasal or nasopharyngeal) collected by a clinician or an anterior nasal swab specimen self-collected at a healthcare location. The test is also CE marked.
Last March, Abbott also announced formation of the Abbott Pandemic Defense Coalition, a first-of-its-kind worldwide scientific and public health partnership dedicated to early detection of and rapid response to future pandemic threats. The initiative connects global centers of excellence in laboratory testing, genetic sequencing, and public health research to identify new pathogens, analyze possible risk level, rapidly develop and deploy new diagnostic testing, and assess public health in real time.
“We cannot fight what we cannot see coming. This program establishes a global network of ‘eyes on the ground’ that are always looking for threats, which helps the global health community to stay one step ahead of the next viral threat, and allows us to utilize Abbott’s expertise and technology to quickly develop tests to address them,” Gavin Cloherty, Ph.D., head of infectious disease research at Abbott, told the press. “The COVID-19 pandemic has demonstrated a clear need for advanced surveillance and viral sequencing—and the critically important role of testing. Understanding what pathogenic threats are emerging will help us test, diagnose, and hopefully help prevent the next pandemic.”
All in all, Abbott’s COVID-19 test-related sales totaled about $7.7 billion in 2021. As a result, Rapid Diagnostics sales nearly doubled last year, growing an impressive 95% to $8.55 billion. Strong demand for Abbott’s point-of-care COVID-19 molecular tests on the ID NOW platform and BinaxNOW COVID-19 Ag Card test in the U.S. and international demand for COVID-19 rapid tests on the Panbio platform drove the drastic increase. The revenue increase also included the recovery of routine diagnostic testing. Rapid Diagnostics COVID-19 testing-related sales accounted for $6.6 billion of the business’s proceeds.
Outside of COVID-19, last January saw 510(k) clearance for the i-STAT Alinity TBI plasma test, the first rapid handheld traumatic brain injury (TBI) blood test, according to Abbott. The test measures specific proteins in the blood after a TBI and generates results in 15 minutes. All the test requires is a small blood sample taken from the arm, from which plasma is extracted with a centrifuge and applied to the test’s cartridge. A negative result can be used to rule out need for a head CT scan, while a positive result complements CT scans to evaluate whether the patient has a TBI.
Core Laboratory Diagnostics sales grew 12.4% to $5.13 billion in 2021, driven by increased volume of routine diagnostic testing in hospitals and labs. This was partially offset by lower sales for lab-based IgG and IgM tests for COVID-19 antibodies.
Molecular Diagnostics sales fell 2.9% from 2020 with posted sales of $1.43 billion. It was the only Abbott medical device or diagnostic business to decline, due to lower demand for lab-based molecular COVID-19 tests on the m2000 platform. This was partially offset by growth in the base business from continued rollout of the Alinity m platform. Molecular Diagnostics COVID-19 testing-related sales last year were $891 million. Point-of-Care diagnostics sales rose 4% to reach $536 million last year.
Although, according to Reuters, Abbott cut its full-year 2021 profit forecast as it expected a sharp revenue decline from its COVID-19 tests as more Americans got vaccinated. Only time will tell whether the company can continue to innovate in critical diagnostic testing areas as the current pandemic continues and future pathogens emerge.
“I think it is important to keep it in perspective here that our revised EPS guidance is up 20% versus last year and more than 30% compared to our pre-pandemic EPS in 2019,” CEO Robert Ford told Forbes last year. “I mentioned that because I think there’s just a couple of companies in our peer group here that have been able to achieve that sort of growth since the start of the pandemic.”
Medical Devices revenue kept pace and increased 19.4% last year, driven by double-digit growth across all divisions and led by Diabetes Care, Structural Heart, and Electrophysiology, which achieved sales growth from pre-pandemic levels. Though cardiovascular and neuromodulation procedure volumes were stifled early in 2021 by elevated COVID-19 case rates in some countries—including the U.S.—overall volumes improved over the course of the year. The Rhythm Management division’s sales expanded 15% in 2021, coming to rest at $2.2 billion.
The Jot Dx insertable cardiac monitor (ICM) launched in the U.S. last July. It continuously monitors cardiac rhythms and connects to the myMerlin mobile app that transmits data in real-time. Physicians can toggle between viewing only three key cardiac episodes or all episodes depending on the patient’s needs. The newly included SyncUP support service also enrolls a newly implanted device in the system, orients the patient to familiarize them with the device, and confirms a connection to the app.
Abbott released late-breaking data from the Leadless II IDE study evaluating the investigational Aveir leadless pacemaker in November. At six weeks post-implant, 96% of patients met the safety endpoint of no serious adverse device effects and 95.9% achieved the efficacy endpoint of acceptable therapy delivered. Physicians were able to accurately position Aveir either the first time or with a single repositioning in 96% of cases. Leadless pacemakers are implanted directly into the heart’s right ventricle via a minimally invasive procedure.
The Electrophysiology business gathered $1.91 billion in 2021, growing 21% from the previous year. Heart Failure proceeds rose 20% to reach $889 million last year. Vascular business revenue totaled $2.65 last year, rising 14% due to a handful of product releases and a new acquisition.
Last April, the Xience stent earned CE mark approval for shorter duration (28 days) of dual anti-platelet therapy (DAPT) post-implant for patients with high bleeding risk. FDA approval for this indication followed suit two months later, as did FDA approval and CE mark clearance for the next-gen Xience Skypoint stent. According to Abbott, Skypoint is easier to place and allows treatment of larger blood vessels via improved stent expansion.
April also saw a CE mark for the company’s new coronary imaging platform powered by Ultreon 1.0 software, which merges optical coherence tomography (OCT) with AI to enhance visualization. It can automatically spot severity of calcium-based blood vessel blockages and measure vessel diameter to boost precision during coronary stenting. The software integrates with the firm’s Dragonfly OpStar imaging catheter to extend OCT’s reach by allowing capture of information from complex patient anatomies. The platform also earned FDA clearance last August.
Abbott also acquired Walk Vascular, and its minimally invasive mechanical aspiration thrombectomy systems to remove peripheral blood clots, last August. The JETi and next-gen JETi AIO (all in one) systems break up and remove clots from peripheral vasculature and reduce risk of dislodged clots. Both systems have 510(k) clearance and CE mark approval. The deal’s financial terms were not disclosed.
Structural Heart revenues flourished last year due to several landmark product introductions, as well as U.S. Centers for Medicare & Medicaid Services (CMS) expanded reimbursement coverage eligibility for MitraClip in January 2021. Last year the business posted $1.61 billion in sales, ballooning 29% over the year prior.
The next-gen TriClip transcatheter tricuspid valve repair system obtained CE mark approval last April. The TriClip G4 clip-based therapy treats the tricuspid—the “forgotten valve” that has had historically limited treatment options. The device treats leaky tricuspid valves and allows clinicians to tailor valve repair to each patient’s unique anatomy. TriClip is delivered to the heart by a catheter inserted through the femoral vein and clips together a portion of the tricuspid valve’s leaflets to reduce the backflow of blood. With a differentiated delivery system designed for the tricuspid valve and steerable guiding catheter system, physicians can independently grasp and effectively clip valve leaflets to reduce regurgitation. TriClip G4 includes two new clip sizes, offering a total of four sizes to tailor the device to different anatomies.
The Navitor transcatheter aortic valve implantation (TAVI) system gained EU approval last May for high or extreme surgical risk, severe aortic stenosis patients. Navitor features a fabric cuff (NaviSeal) that works with the cardiac cycle to remove paravalvular leak. The self-expanding TAVI system has intra-annular leaflets and large frame cells to improve access to critical coronary arteries. The new design also improves hemodynamics.
A month later, the Amplatzer steerable delivery sheath obtained CE mark and Health Canada approval. Used with the Amplatzer Amulet LAA occluder, the delivery sheath was developed specifically for minimally invasive LAA occlusion procedures for atrial fibrillation patients at risk of ischemic stroke. The sheath has bi-directional steering and an auto-lock setting for more accurate alignment with the LAA. A hemostasis valve helps stabilize blood flow and minimize blood loss during the operation, and the new design removes the need for catheter manipulation or exchanges.
The Amplatzer Amulet LAA occluder gained FDA approval last August. The device’s dual-seal technology helps immediately close the LAA to reduce stroke risk in atrial fibrillation patients and eliminates the need for blood-thinning medication. Amulet can treat a wide range of anatomies with the widest range of occluder sizes on the market. It’s also recapturable and repositionable for optimal placement.
September saw FDA approval for the Portico with FlexNav transcatheter aortic valve replacement (TAVR) system for symptomatic, severe aortic stenosis patients at high or extreme risk for open-heart surgery. Portico is self-expanding with intra-annular leaflets to help provide optimal blood flow. The replacement valve’s structure preserves access to critical coronary arteries for future interventions. Portico is implanted using the FlexNav delivery system, whose slim design accommodates different anatomies and small vessels.
That same month the FDA approved the firm’s Amplatzer Talisman PFO (patent foramen ovale) occlusion system to treat those at risk of recurrent ischemic stroke thanks to PFO. The next-gen system adds an additional 30 mm device size and comes pre-attached to the delivery cable. The Talisman delivery sheath was also approved.
Completing the trifecta in September was FDA approval for the company’s Epic Plus and Epic Plus Supra stented tissue valves for aortic or mitral valve disease. Enhancements included more radiopaque markers that make it easier for navigation if future transcatheter procedures are needed. The Epic Plus Mitral holder helps to ensure precise insertion of the valve via lower profile, so physicians have a better view of the device for accurate placement during implantation.
Although Neuromodulation business procedure volumes took a hit early in 2021 due to elevated COVID-19 cases, the division posted $781 million in proceeds to rise 11% over 2020.
Last March, the business launched the NeuroSphere virtual clinic in the U.S. The technology enables patients using Abbott’s suite of neuromodulation technologies to communicate with their physicians and remotely receive stimulation settings in real time, regardless of their location. Clinicans can prescribe new treatment settings remotely to the neurostimulation device using a programmer app and secure remote care connection.
The Diabetes Care business accrued $4.33 billion last year, rising an impressive 24.5% in sales over the previous year.
The business achieved FDA clearance for the FreeStyle Libre 2 iOS application for compatible iPhones last August. The app pairs with the FreeStyle Libre 2 continuous glucose monitor (CGM). The app lets users get glucose readings directly on their iPhones without a reader, and caregivers can remotely monitor glucose readings and get real-time alarms. Users also receive a trend arrow to help determine how food, exercise, and other lifestyle factors impact their diabetes management.
However, also in August, Abbott settled to pay $160 million to resolve claims that two of its units submitted false claims to Medicare by providing kickbacks to diabetes patients, including “free” or “no cost” glucose monitors, according to the U.S. Department of Justice. The claim was made against Arriva Medical, a Medicare mail-order diabetes testing supplier, and its parent company Alere, that Abbott acquired in 2017. Arriva was also accused of systematically charging Medicare, a U.S. government health plan, for glucometers given to ineligible patients, and submitting claims for 211 patients who had been dead at least two weeks.
Longtime CEO Miles D. White officially left Abbott in December when he stepped down as the company’s executive chairman after a remarkable 38-year tenure. Current CEO Robert Ford took his place on Dec. 10.
“It’s been my privilege to serve Abbott and its many stakeholders, reshaping the company to keep it relevant and strong while medicine, technology and society have evolved,” White told the press. “Abbott will be in good hands with Robert’s leadership, and I want to thank the board and my colleagues—current and past—for their support during my tenure.”
$30.01 Billion ($43.1B total)
Prior Fiscal: $22.59 Billion
Percentage Change: +32.8%
R&D Expenditure: $2.7B
Best FY21 Quarter: Q4 $8.22B
Latest Quarter: Q1 $8.85B
No. of Employees: 113,000 (total)
Global Headquarters: Abbott Park, Ill.
KEY EXECUTIVES:
Robert B. Ford, Chairman and CEO
Robert E. Funck Jr., Exec. VP and CFO
John M. Capek, Ph.D., Exec. VP, Ventures
Lisa D. Earnhardt, Exec. VP, Medical Devices
John F. Ginascol, Exec. VP, Core Diagnostics
Andrea F. Wainer, Exec. VP, Rapid and Molecular Diagnostics
Abbott Labs has reached the Top 30’s runner-up spot for the first time, and it’s predominantly thanks to the company’s innovation in response to the dire need for quick and accurate diagnostic testing for COVID-19.
Abbott began the year by fulfilling the U.S. federal government’s order of 150 million BinaxNOW COVID-19 Ag tests. The 15-minute, credit card-sized tests were distributed through the U.S. Department of Health and Human Services (HHS) to states, territories, and targeted entities, such as nursing homes, assisted living facilities, home health and hospice agencies, historically black colleges and universities (HBCUs), and the Indian Health Service. Two months later, the at-home version of the test earned emergency use authorization for asymptomatic, non-prescription, over-the-counter self-use. Abbott began shipping the self-tests to retailers a month later.
“Let’s not back down on testing, let’s double down on it,” Thomas Quinn, M.D., professor of medicine and pathology at the Johns Hopkins School of Medicine, told the press. “As long as COVID remains unpredictable, there’s an important role for the corner pharmacy and the central lab to tackle this virus in tandem, which gives this country the best chance to detect and screen for COVID-19.”
The Panbio COVID-19 Ag Rapid Test Device earned CE mark approval for asymptomatic screening and self-administered sample collection with a nasal swab last January as well. The test also delivers results as early as 15 minutes with no instrumentation. The self-test version of the Panbio COVID-19 test earned a CE mark last June, allowing it to be sold directly to consumers with or without symptoms.
ANALYST INSIGHTS: Abbott was on fire in Q1 2022 with growth across their various business units, but then crashed and burned in Q2 due to their now infamous challenges to produce infant formula. While they may be still making money, they have a lot of work to do to enhance their image with the American public and the FDA. I’m guessing Abbott is up to the challenge and the company will be once again rising to the occasion in 2023. Rearview mirror can’t come fast enough for CEO Robert Ford.
—Dave Sheppard, Co-Founder and Managing Director, MedWorld Advisors
Last March saw FDA emergency use authorization for the company’s Alinity m Resp-4-Plex molecular assay to detect and differentiate SARS-CoV-2, influenza A, influenza B, and respiratory syntactical virus (RSV) in one test. The test can be conducted via either one swab specimen (anterior nasal or nasopharyngeal) collected by a clinician or an anterior nasal swab specimen self-collected at a healthcare location. The test is also CE marked.
Last March, Abbott also announced formation of the Abbott Pandemic Defense Coalition, a first-of-its-kind worldwide scientific and public health partnership dedicated to early detection of and rapid response to future pandemic threats. The initiative connects global centers of excellence in laboratory testing, genetic sequencing, and public health research to identify new pathogens, analyze possible risk level, rapidly develop and deploy new diagnostic testing, and assess public health in real time.
“We cannot fight what we cannot see coming. This program establishes a global network of ‘eyes on the ground’ that are always looking for threats, which helps the global health community to stay one step ahead of the next viral threat, and allows us to utilize Abbott’s expertise and technology to quickly develop tests to address them,” Gavin Cloherty, Ph.D., head of infectious disease research at Abbott, told the press. “The COVID-19 pandemic has demonstrated a clear need for advanced surveillance and viral sequencing—and the critically important role of testing. Understanding what pathogenic threats are emerging will help us test, diagnose, and hopefully help prevent the next pandemic.”
All in all, Abbott’s COVID-19 test-related sales totaled about $7.7 billion in 2021. As a result, Rapid Diagnostics sales nearly doubled last year, growing an impressive 95% to $8.55 billion. Strong demand for Abbott’s point-of-care COVID-19 molecular tests on the ID NOW platform and BinaxNOW COVID-19 Ag Card test in the U.S. and international demand for COVID-19 rapid tests on the Panbio platform drove the drastic increase. The revenue increase also included the recovery of routine diagnostic testing. Rapid Diagnostics COVID-19 testing-related sales accounted for $6.6 billion of the business’s proceeds.
Outside of COVID-19, last January saw 510(k) clearance for the i-STAT Alinity TBI plasma test, the first rapid handheld traumatic brain injury (TBI) blood test, according to Abbott. The test measures specific proteins in the blood after a TBI and generates results in 15 minutes. All the test requires is a small blood sample taken from the arm, from which plasma is extracted with a centrifuge and applied to the test’s cartridge. A negative result can be used to rule out need for a head CT scan, while a positive result complements CT scans to evaluate whether the patient has a TBI.
Core Laboratory Diagnostics sales grew 12.4% to $5.13 billion in 2021, driven by increased volume of routine diagnostic testing in hospitals and labs. This was partially offset by lower sales for lab-based IgG and IgM tests for COVID-19 antibodies.
Molecular Diagnostics sales fell 2.9% from 2020 with posted sales of $1.43 billion. It was the only Abbott medical device or diagnostic business to decline, due to lower demand for lab-based molecular COVID-19 tests on the m2000 platform. This was partially offset by growth in the base business from continued rollout of the Alinity m platform. Molecular Diagnostics COVID-19 testing-related sales last year were $891 million. Point-of-Care diagnostics sales rose 4% to reach $536 million last year.
Although, according to Reuters, Abbott cut its full-year 2021 profit forecast as it expected a sharp revenue decline from its COVID-19 tests as more Americans got vaccinated. Only time will tell whether the company can continue to innovate in critical diagnostic testing areas as the current pandemic continues and future pathogens emerge.
“I think it is important to keep it in perspective here that our revised EPS guidance is up 20% versus last year and more than 30% compared to our pre-pandemic EPS in 2019,” CEO Robert Ford told Forbes last year. “I mentioned that because I think there’s just a couple of companies in our peer group here that have been able to achieve that sort of growth since the start of the pandemic.”
Medical Devices revenue kept pace and increased 19.4% last year, driven by double-digit growth across all divisions and led by Diabetes Care, Structural Heart, and Electrophysiology, which achieved sales growth from pre-pandemic levels. Though cardiovascular and neuromodulation procedure volumes were stifled early in 2021 by elevated COVID-19 case rates in some countries—including the U.S.—overall volumes improved over the course of the year. The Rhythm Management division’s sales expanded 15% in 2021, coming to rest at $2.2 billion.
The Jot Dx insertable cardiac monitor (ICM) launched in the U.S. last July. It continuously monitors cardiac rhythms and connects to the myMerlin mobile app that transmits data in real-time. Physicians can toggle between viewing only three key cardiac episodes or all episodes depending on the patient’s needs. The newly included SyncUP support service also enrolls a newly implanted device in the system, orients the patient to familiarize them with the device, and confirms a connection to the app.
Abbott released late-breaking data from the Leadless II IDE study evaluating the investigational Aveir leadless pacemaker in November. At six weeks post-implant, 96% of patients met the safety endpoint of no serious adverse device effects and 95.9% achieved the efficacy endpoint of acceptable therapy delivered. Physicians were able to accurately position Aveir either the first time or with a single repositioning in 96% of cases. Leadless pacemakers are implanted directly into the heart’s right ventricle via a minimally invasive procedure.
The Electrophysiology business gathered $1.91 billion in 2021, growing 21% from the previous year. Heart Failure proceeds rose 20% to reach $889 million last year. Vascular business revenue totaled $2.65 last year, rising 14% due to a handful of product releases and a new acquisition.
Last April, the Xience stent earned CE mark approval for shorter duration (28 days) of dual anti-platelet therapy (DAPT) post-implant for patients with high bleeding risk. FDA approval for this indication followed suit two months later, as did FDA approval and CE mark clearance for the next-gen Xience Skypoint stent. According to Abbott, Skypoint is easier to place and allows treatment of larger blood vessels via improved stent expansion.
April also saw a CE mark for the company’s new coronary imaging platform powered by Ultreon 1.0 software, which merges optical coherence tomography (OCT) with AI to enhance visualization. It can automatically spot severity of calcium-based blood vessel blockages and measure vessel diameter to boost precision during coronary stenting. The software integrates with the firm’s Dragonfly OpStar imaging catheter to extend OCT’s reach by allowing capture of information from complex patient anatomies. The platform also earned FDA clearance last August.
Abbott also acquired Walk Vascular, and its minimally invasive mechanical aspiration thrombectomy systems to remove peripheral blood clots, last August. The JETi and next-gen JETi AIO (all in one) systems break up and remove clots from peripheral vasculature and reduce risk of dislodged clots. Both systems have 510(k) clearance and CE mark approval. The deal’s financial terms were not disclosed.
Structural Heart revenues flourished last year due to several landmark product introductions, as well as U.S. Centers for Medicare & Medicaid Services (CMS) expanded reimbursement coverage eligibility for MitraClip in January 2021. Last year the business posted $1.61 billion in sales, ballooning 29% over the year prior.
The next-gen TriClip transcatheter tricuspid valve repair system obtained CE mark approval last April. The TriClip G4 clip-based therapy treats the tricuspid—the “forgotten valve” that has had historically limited treatment options. The device treats leaky tricuspid valves and allows clinicians to tailor valve repair to each patient’s unique anatomy. TriClip is delivered to the heart by a catheter inserted through the femoral vein and clips together a portion of the tricuspid valve’s leaflets to reduce the backflow of blood. With a differentiated delivery system designed for the tricuspid valve and steerable guiding catheter system, physicians can independently grasp and effectively clip valve leaflets to reduce regurgitation. TriClip G4 includes two new clip sizes, offering a total of four sizes to tailor the device to different anatomies.
The Navitor transcatheter aortic valve implantation (TAVI) system gained EU approval last May for high or extreme surgical risk, severe aortic stenosis patients. Navitor features a fabric cuff (NaviSeal) that works with the cardiac cycle to remove paravalvular leak. The self-expanding TAVI system has intra-annular leaflets and large frame cells to improve access to critical coronary arteries. The new design also improves hemodynamics.
A month later, the Amplatzer steerable delivery sheath obtained CE mark and Health Canada approval. Used with the Amplatzer Amulet LAA occluder, the delivery sheath was developed specifically for minimally invasive LAA occlusion procedures for atrial fibrillation patients at risk of ischemic stroke. The sheath has bi-directional steering and an auto-lock setting for more accurate alignment with the LAA. A hemostasis valve helps stabilize blood flow and minimize blood loss during the operation, and the new design removes the need for catheter manipulation or exchanges.
The Amplatzer Amulet LAA occluder gained FDA approval last August. The device’s dual-seal technology helps immediately close the LAA to reduce stroke risk in atrial fibrillation patients and eliminates the need for blood-thinning medication. Amulet can treat a wide range of anatomies with the widest range of occluder sizes on the market. It’s also recapturable and repositionable for optimal placement.
September saw FDA approval for the Portico with FlexNav transcatheter aortic valve replacement (TAVR) system for symptomatic, severe aortic stenosis patients at high or extreme risk for open-heart surgery. Portico is self-expanding with intra-annular leaflets to help provide optimal blood flow. The replacement valve’s structure preserves access to critical coronary arteries for future interventions. Portico is implanted using the FlexNav delivery system, whose slim design accommodates different anatomies and small vessels.
That same month the FDA approved the firm’s Amplatzer Talisman PFO (patent foramen ovale) occlusion system to treat those at risk of recurrent ischemic stroke thanks to PFO. The next-gen system adds an additional 30 mm device size and comes pre-attached to the delivery cable. The Talisman delivery sheath was also approved.
Completing the trifecta in September was FDA approval for the company’s Epic Plus and Epic Plus Supra stented tissue valves for aortic or mitral valve disease. Enhancements included more radiopaque markers that make it easier for navigation if future transcatheter procedures are needed. The Epic Plus Mitral holder helps to ensure precise insertion of the valve via lower profile, so physicians have a better view of the device for accurate placement during implantation.
Although Neuromodulation business procedure volumes took a hit early in 2021 due to elevated COVID-19 cases, the division posted $781 million in proceeds to rise 11% over 2020.
Last March, the business launched the NeuroSphere virtual clinic in the U.S. The technology enables patients using Abbott’s suite of neuromodulation technologies to communicate with their physicians and remotely receive stimulation settings in real time, regardless of their location. Clinicans can prescribe new treatment settings remotely to the neurostimulation device using a programmer app and secure remote care connection.
The Diabetes Care business accrued $4.33 billion last year, rising an impressive 24.5% in sales over the previous year.
The business achieved FDA clearance for the FreeStyle Libre 2 iOS application for compatible iPhones last August. The app pairs with the FreeStyle Libre 2 continuous glucose monitor (CGM). The app lets users get glucose readings directly on their iPhones without a reader, and caregivers can remotely monitor glucose readings and get real-time alarms. Users also receive a trend arrow to help determine how food, exercise, and other lifestyle factors impact their diabetes management.
However, also in August, Abbott settled to pay $160 million to resolve claims that two of its units submitted false claims to Medicare by providing kickbacks to diabetes patients, including “free” or “no cost” glucose monitors, according to the U.S. Department of Justice. The claim was made against Arriva Medical, a Medicare mail-order diabetes testing supplier, and its parent company Alere, that Abbott acquired in 2017. Arriva was also accused of systematically charging Medicare, a U.S. government health plan, for glucometers given to ineligible patients, and submitting claims for 211 patients who had been dead at least two weeks.
Longtime CEO Miles D. White officially left Abbott in December when he stepped down as the company’s executive chairman after a remarkable 38-year tenure. Current CEO Robert Ford took his place on Dec. 10.
“It’s been my privilege to serve Abbott and its many stakeholders, reshaping the company to keep it relevant and strong while medicine, technology and society have evolved,” White told the press. “Abbott will be in good hands with Robert’s leadership, and I want to thank the board and my colleagues—current and past—for their support during my tenure.”