It’s said that the best things come in small packages. That’s certainly true of Abbott’s portfolio of structural heart devices, where life-changing innovations are measured in millimeters. But these miniscule marvels are driving impressive results in the Structural Heart business, which has experienced nine consecutive quarters of double-digit organic1,2 growth.
Sandra Lesenfants, senior vice president, Structural Heart, has been leading the business since joining Abbott in November 2023. As she wraps up her first year at Abbott, she shares her perspective on where the Structural Heart business is – and where it’s going.
For investors who aren’t familiar with Abbott, what is the focus of the Structural Heart business and the products in its portfolio?
Structural Heart is one of seven businesses within Abbott’s Medical Devices division, and we create medical device solutions for defects in the structure of the heart. We have the most comprehensive structural heart treatment portfolio in the industry and have pioneered devices that address critical unmet needs for people of all ages with these highly complex heart issues.
One of the products Structural Heart is most known for is MitraClip, the world’s first minimally invasive transcatheter edge-to-edge repair (TEER) therapy that treats primary or secondary mitral regurgitation without the need for open-heart surgery. MitraClip was approved in the U.S. in 2013 and has treated more than 200,000 people in more than 75 countries.
MitraClip has been an important part of our portfolio, and it will remain so. Over the past decade we’ve continued to invest to create a diversified portfolio of surgical heart valves, the Amplatzer family of occluders that repair a range of heart defects, our Navitor transcatheter aortic valve implantation (TAVI) system for people with severe aortic stenosis who are at high or extreme risk for open-heart surgery, and TriClip, Abbott’s first-of-its-kind clip-based device designed to repair the tricuspid valve, which was approved by the FDA earlier this year
What is the latest on MitraClip?
Now on its fourth generation, MitraClip continues to be a safe and effective treatment option with a strong foundation of clinical evidence from more than 20 clinical trials. Most recently at the European Society of Cardiology (ESC) Congress 2024 and now at the 36th Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium, findings from the RESHAPE HF2 and MATTERHORN studies have shown that MitraClip decreased hospitalizations, improved quality-of-life scores and has an excellent safety profile compared to other treatment options.
And what has the response been to TriClip since its FDA approval?
We’ve been thrilled to see strong adoption of TriClip across the U.S. To date, more than 10,000 people with tricuspid regurgitation (TR) have had their lives changed by this technology. An important part of this process is working with hospitals and their staff to educate them on how this therapy can be used safely and effectively to treat a leaky tricuspid valve.
While we’re proud to have secured approval, our work is never done. We remain focused on establishing TriClip as a new therapy and building the foundation of understanding and expertise with this therapy to improve the lives of eligible patients with TR. This is reflected in the fact that TriClip is the only tricuspid transcatheter edge to edge repair (TEER) technology supported by two randomized, controlled clinical trials and one real-world study.
Abbott has formally requested the Centers for Medicare and Medicaid Services to develop a national coverage determination (NCD) for T-TEER. TriClip represents an important intervention for patients suffering from TR, offering a safe and effective treatment that can greatly improve quality of life. We are encouraged by CMS’s recognition of the importance of addressing TR and its impacts on heart failure, and we look forward to contributing our insights during the comment period to support broad patient access to this vital therapy.
This business has reported 15 consecutive quarters of meaningful growth. What’s fueling this?
Innovation is an important factor, and I’m extremely proud of the life-changing products we’ve introduced. But as we continue to build upon our portfolio, we have also turned our attention to driving adoption. We’re focused on introducing U.S. hospitals to our products and understanding their needs so we can work together to deliver positive outcomes for patients.
Looking ahead, what’s on the horizon for Structural Heart?
Healthcare has made meaningful advancements in addressing heart disease, but we have significant work to do to treat conditions that affect the structures and functioning of the heart. We are just scratching the surface of treating people with these conditions. Patients and the doctors who care for them need a variety of therapeutic options, including repair and replacement options to address structural issues within the heart, which is why we continue to deepen our portfolio and develop products to meet these needs. We are investing in clinical research to help drive access and advance our understanding of structural heart issues and the best ways to treat them to help patients receive the care they need.
You’re coming up on one year at Abbott. What has been one or two highlights from the past 12 months?
It was exciting to be a part of securing FDA approval of TriClip, which was a big milestone for our team, the company and the industry, and it received a strong positive vote by an independent panel of physicians.
Secondly, working closely with our TAVI team has been rewarding for me professionally and personally. The TAVI industry already has a variety of treatment options, so it's important that the new solutions we investigate and offer make a meaningful difference for those with aortic stenosis, an all-too-common and life-threatening heart valve disease. I’m excited to share more in the months and years to come about how we are investing in this space to ensure that patients with aortic stenosis have access to safe and effective treatment options that fit their needs, and not the other way around.
How would you describe your vision for Structural Heart?
What I want for this division is the same as the reason I got into health care in the first place: I want us to help people by making a meaningful difference in their lives.
At Abbott, as well as for me personally, that means driving innovation by listening to cardiologists about what is needed to better treat individuals with structural heart conditions and then bringing products to the market that not only address those needs but also save, extend or improve lives. It means finding ways for doctors to help patients without causing undue side effects or requiring people to undergo extensive surgery that will result in extended hospital stays. It means providing technology that is safer and easier for doctors to use or that addresses a particular pain point they have when treating the structural heart issue.
Finally, what is one thing people should know about Abbott’s Medical Devices division in general, and Structural Heart in particular?
I think that one of the most important things to know is that we’re really thinking holistically about how our offerings can improve outcomes for patients while maximizing care delivery for physicians. Our goal is always to develop technology that will help people live longer and healthier lives and to contribute to the lifetime management of those people. That is what has contributed to our strong performance and will continue to do so.
To learn more about Sandra Lesenfants and Abbott’s Structural Heart business, listen to her interview on DeviceTalks.
References
1Organic sales growth excludes the impact of foreign exchange. For reconciliation of non-GAAP measures, please see our press releases dated April 20, 2021, July 22, 2021, Oct. 20, 2021, Jan. 26, 2022, April 20, 2022, July 20, 2022, Oct. 19, 2022, Jan. 25, 2023, April 19, 2023, July 20, 2023, Oct. 18, 2023, Jan. 24, 2024, April 17, 2024, and Oct. 16, 2024, available at www.abbottinvestor.com.
2On a GAAP basis, first quarter 2021 Structural Heart sales increased 18.6%, second quarter 2021 Structural Heart sales increased 89.2%, third quarter 2021 Structural Heart sales increased 11.0%, fourth quarter 2021 Structural Heart sales increased 18.7%, first-quarter 2022 Structural Heart sales increased 9.1%, second quarter 2022 Structural Heart sales increased 4.2%, third quarter 2022 Structural Heart sales increased 7.2%, fourth quarter 2022 Structural Heart sales increased 5.2%, first-quarter 2023 Structural Heart sales increased 12.2%, second quarter 2023 Structural Heart sales increased 13.3%, third quarter 2023 Structural Heart sales increased 15.8%, fourth quarter 2023 Structural Heart sales increased 12.9%, first-quarter 2024 Structural Heart sales increased 11.7%, second quarter 2024 Structural Heart sales increased 13.2%, and third quarter 2024 Structural Heart sales increased 14.6%.
Important safety information
NAVITOR TRANSCATHETER AORTIC VALVE IMPLANTATION SYSTEM
TRICLIP™ G4 SYSTEM
MITRACLIP DELIVERY SYSTEMS
Rx Only
INDICATION FOR USE
CONTRAINDICATIONS
The MitraClip G4 System is contraindicated in patients with the following conditions: Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or post procedural anti-platelet regime; Patients with known hypersensitivity to clip components (nickel / titanium, cobalt, chromium, polyester), or with contrast sensitivity; Active endocarditis of the mitral valve; Rheumatic mitral valve disease; Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus.
POTENTIAL COMPLICATIONS AND ADVERSE EVENTS
The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClip G4 procedure: Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials (nickel / titanium, cobalt, chromium, polyester), and drug reactions to anticoagulation, or antiplatelet drugs, Vascular access complications which may require transfusion or vessel repair including: wound dehiscence, catheter site reactions, Bleeding (including ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage), Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, vascular occlusion, Emboli (air thrombotic material, implant, device component); Peripheral Nerve Injury; Lymphatic complications; Pericardial complications which may require additional intervention, including: Pericardial effuse on, Cardiac tamponade, Pericarditis; Cardiac complications which may require additional interventions or emergency cardiac surgery, including: Cardiac perforation, Atrial septal defect; Mitral valve complications, which may complicate or prevent later surgical repair, including: Chordal entanglement / rupture, Single Leaflet Device Attachment (SLDA), Thrombosis, Dislodgement of previously implanted devices, Tissue damage, Mitral valve stenosis, Persistent or residual mitral regurgitation, Endocarditis; Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias); Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, and unstable / stable angina); Venous thromboembolism (including deep vein thrombosis, pulmonary embolism, post procedure pulmonary embolism); Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA); System organ failure: Cardio-respiratory arrest, Worsening heart failure, Pulmonary congestion, Respiratory dysfunction / failure / atelectasis, Renal insufficiency or failure, Shock (including cardiogenic and anaphylactic); Blood cell disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT)); Hypotension / hypertension; Infection including: Urinary Tract Infection (UTI), Pneumonia, Septicemia; Nausea / vomiting; Chest pain; Dyspnea; Edema; Fever or hyperthermia; Pain; Death; Fluoroscopy, Transesophageal echocardiogram (TEE) and Transthoracic echocardiogram (TTE) -related complications: Skin injury or tissue changes due to exposure to ionizing radiation, Esophageal irritation; Esophageal perforation, Gastrointestinal bleeding.
NAVITOR TRANSCATHETER AORTIC VALVE IMPLANTATION SYSTEM
Rx Only
Indications
The Navitor™ Transcatheter Aortic Valve Implantation System is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator).
Contraindications
The valve is contraindicated for patients with inability to tolerate antiplatelet/anticoagulant therapy or nitinol alloy (nickel and titanium), or who have active infections, including endocarditis.
Potential Adverse Events
Adverse events potentially associated with the use of transcatheter bioprosthetic heart valves include but are not limited to: access site complications (e.g., pain, bleeding, infection, hematoma, pseudoaneurysm, etc.); acute coronary obstruction; acute myocardial infarction; allergic reaction to antiplatelet agents, contrast medium, or valve components; aortic rupture; ascending aorta trauma; atrio-ventricular node block; cardiac arrhythmias; conduction system injury; conversion to open surgical procedure; death; dissection; embolism; emergent balloon valvuloplasty; emergent percutaneous coronary intervention (PCI); emergent surgery (i.e., coronary artery bypass, heart valve replacement); endocarditis; explantation; heart failure; hemodynamic compromise; hemolysis; hemolytic anemia; hemorrhage; hypotension or hypertension; infection; myocardial ischemia; mitral valve insufficiency; multi-organ failure; non-structural dysfunction (i.e., entrapment by pannus, paravalvular leak, inappropriate sizing or positioning); pannus; pericardial effusion; perforation of the myocardium, ventricle, or a blood vessel; permanent disability; permanent pacemaker; regurgitation; renal insufficiency or renal failure; reoperation; respiratory failure; sepsis; stroke; structural deterioration (i.e., calcification, leaflet tear); thrombosis; tamponade; transfusion; valve embolization or migration; vessel dissection or spasm.
TRICLIP™ G4 SYSTEM
Rx Only
INDICATIONS
The TriClip™ G4 System is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are at intermediate or greater risk for surgery and in whom transcatheter edge-to-edge valve repair is clinically appropriate and is expected to reduce tricuspid regurgitation severity to moderate or less, as determined by a multidisciplinary heart team.
CONTRAINDICATIONS
The TriClip G4 System is contraindicated in patients with the following conditions: Intolerance, including allergy or untreatable hypersensitivity, to procedural anticoagulation; Untreatable hypersensitivity to implant components (nickel-titanium alloy, cobalt-chromium alloy); Active endocarditis or other active infection of the tricuspid valve. POTENTIAL
ADVERSE EVENTS
The following events have been identified as possible complications of the TriClip™ G4 Procedure. Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials and drug reactions to anticoagulation, or antiplatelet drugs; Additional treatment / surgery from device-related complications; Bleeding; Blood disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT)); Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias); Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, and unstable / stable angina); Cardiac perforation; Cardiac tamponade; Chest pain; Death; Dyspnea; Edema; Embolization (device or components of the device); Endocarditis; Fever or hyperthermia; Fluoroscopy, Transesophageal echocardiogram (TEE) and Transthoracic echocardiogram (TTE) -related complications: Skin injury or tissue changes due to exposure to ionizing radiation, Esophageal irritation, Esophageal perforation, Gastrointestinal bleeding; Hypotension / hypertension; Infection including: Septicemia; Nausea / vomiting; Pain; Pericardial effusion; Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA); System organ failure: Cardio-respiratory arrest, Worsening heart failure, Pulmonary congestion, Respiratory dysfunction / failure / atelectasis, Renal insufficiency or failure, Shock (including cardiogenic and anaphylactic); Thrombosis; Tricuspid valve complications, which may complicate or prevent later surgical repair, including: Chordal entanglement / rupture, Single Leaflet Device Attachment (SLDA), Dislodgement of previously implanted devices, Tissue damage, Tricuspid valve stenosis, Worsening, Persistent or residual regurgitation; Vascular access complications which may require additional intervention, including: Wound dehiscence, Bleeding of the access site, Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, vascular occlusion, Embolism (air, thrombus), Peripheral nerve injury; Venous thromboembolism (including deep vein thrombosis, pulmonary embolism). CAUTION: Product(s) intended for use by or under the direction of a physician. Prior to use, reference to the Instructions for Use, inside the product carton (when available) or at https://www.eifu.abbott/ for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
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