New data supports key devices in Abbott's innovative cardiovascular portfolio.

Apr 18 2019

Picture life-changing innovation coming from devices that fit in the palm of your hand.

Because healthy bodies start with strong hearts and robust cardiovascular systems, Abbott continues to lead in many areas of cardiac health with new versions of its medical devices. They're often dime-sized or even smaller, but their impact can be enormous.

From heart valves and vascular stents to heart pumps and implantable cardiac monitors, our best-in-class lineup reflects crucial breakthroughs in research and development to combat many types of heart disease and their side effects.

New clinical data adds even more support to Abbott's cardiovascular portfolio, improving patient care and continuing to build momentum for one of the company's fastest-growing businesses.

Abbott's medical device sales rose 9.1 percent for 2018 compared with a year earlier, helping the company build on its sustainable growth and fund new research to continually improve its device portfolio.

Investing in medical devices is another example of Abbott being well positioned in the right segments, as the $40 billion cardiovascular device market today could grow to $66 billion by 2024.[1]

Fresh data enhances outlook

Research presented at the American College of Cardiology's (ACC) 68th Annual Scientific Session in New Orleans suggests expanded, game-changing potential for these devices.

Abbott's technologies can treat complex cardiac conditions and heart disease in ways that could lower health care costs, reduce hospitalizations and improve survival. For physicians, the findings give them new ways to think about how to treat patients with heart conditions.

"What we unveiled at ACC demonstrates the unique potential our devices have to improve the everyday lives of people with cardiovascular conditions," said Dr. Mark Carlson, divisional vice president and chief medical officer, Cardiac Arrhythmias and Heart Failure, Abbott. "We're pleased with the research and clinical study outcomes in terms of improving patient care and earning the trust of medical professionals looking for the leading treatments for their patients."

Continued innovation to help people

With 121 million Americans having some form of cardiovascular disease and nearly 6 million Americans affected by heart failure today – a figure that is forecast to grow to 8 million by 2030 – the urgency for more effective devices will only increase.

Abbott's portfolio of devices each address aspects of cardiovascular health and continue to build the company's leadership in one of the fast-growing segments of medicine. The clinical trial results revealed at ACC included:

  • Two data sets backing Abbott's MitraClip device for mitral valve repair for patients with heart failure and secondary mitral regurgitation. The initial data from the COAPT study showed MitraClip was superior to medical therapy for treating select heart failure patients, and the latest data gave further evidence supporting the device's effectiveness With the recent U.S. regulatory approval for an expanded indication for MitraClip, the treatment's appeal has expanded significantly to improve quality of life for heart failure patients compared with other treatments. MitraClip is likely to reach 2-3 times as many people with this news, which solidifies its position in the fast-growing Structural Heart segment that is among Abbott's best-performing businesses.
  • More data from the MOMENTUM 3 study evaluating two-year survival of 1,028 study participants who received either Abbott's HeartMate 3 heart pump or Abbott's HeartMate II. Since its launch, the HeartMate 3 heart pump has built upon the success of the HeartMate II, the previous gold standard in mechanical circulatory support. MOMENTUM 3 is the world's largest randomized controlled study of left ventricular assist device (LVAD) therapy to date, and the results for HeartMate 3 showed best-in-class survival rate and the lowest published rates of stroke and thrombosis (blood clots).
  • The latest research for Abbott's CardioMEMS HF System, the world's only commercially approved pulmonary artery pressure sensor. To date, data for CardioMEMS has been shown to yield significant reductions in heart failure rehospitalization for people with New York Heart Association (NYHA) Class III heart failure. Abbott's CardioMEMS System enables physicians to remotely monitor by tracking changes in pulmonary pressure – a sign of worsening heart failure – and appropriately treat them before symptoms progress.
  • Finally, research from Japan supporting Abbott's XIENCE drug eluting coronary stents. The randomized study looked at 3,009 patients treated with dual antiplatelet therapy following percutaneous coronary intervention procedures with XIENCE at one month versus 12 months. The new data enhances understanding around the possibility of decreasing the duration of these medications that can reduce clotting but also carry a risk of increased bleeding.

With this expanding line of medical devices aimed at improving cardiovascular health, Abbott will build on its market-leading position to improve patient care. More life-changing improvements are coming from the company's development pipeline, part of the measured strategy to sustain Abbott's revenue growth for years to come.

[1] Source: https://www.zionmarketresearch.com/news/cardiovascular-devices-market

About the COAPT Trial
In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) Trial, 614 symptomatic heart failure patients with moderate-to-severe or severe secondary MR were randomized to receive treatment with MitraClip plus guideline-directed medical therapy or guideline-directed medical therapy alone at 78 sites in the U.S. and Canada. Eligible patients had diseased heart muscle, known as dilated cardiomyopathy that reduced the amount of blood pumped from the left ventricle; and moderate-to-severe or severe MR assessed by the American Society of Echocardiography guidelines that remained symptomatic despite maximally-tolerated medical therapy and cardiac resynchronization therapy (if appropriate).10,11 Mean patient age was 72.2 years, and 64 percent were male.

The primary efficacy endpoint in the COAPT Trial was all heart failure hospitalizations through two years, and the primary safety endpoint was freedom from device-related complications at one year compared to a performance goal of 88 percent. Secondary endpoints included all-cause mortality at two years, change in quality-of-life at one year, change in functional capacity (six minute walk distance) at one year, MR severity at one year and left ventricle size at one year. The COAPT Trial met its primary endpoints and all 10 secondary endpoints as presented during the TCT cardiology meeting in Sept. 2018 and published in the New England Journal of Medicine.12

About MitraClip
MitraClip received CE Mark in Europe in 2008 and was approved by the FDA in 2013 for primary MR prohibitive risk patients (patients not eligible for open-heart surgery). The FDA approved an expanded indication for MitraClip to treat secondary MR in March 2019. Delivered through a minimally invasive catheter, MitraClip secures a portion of the leaflets of the mitral valve with an implanted clip, allowing the heart to pump blood more efficiently throughout the body, thereby relieving the symptoms of MR and improving patient quality of life.

Patients with MR are often not eligible for standard-of-care surgery because of advanced age, frailty, multiple comorbidities or other complicating factors, and the therapy offers a minimally invasive alternative. The transcatheter clip-based therapy, now on a third generation of product innovations, has been used to treat over 80,000 people with MR worldwide for over 10 years.

For more information on MitraClip, visit: www.structuralheartsolutions.com.

For U.S. Important Safety Information about MitraClip, visit: https://www.structuralheartsolutions.com/us/mitraclip-isi.

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

1 Asgar AW, Mack MJ, Stone GW. Secondary mitral regurgitation in heart failure: pathophysiology, prognosis, and therapeutic considerations. J Am Coll Cardiol 2015;65:1231-48.
2 Dwivedi A, Vainrib A, Saric M. Functional mitral regurgitation in patients with heart failure and depressed ejection fraction. Current Opinion in Cardiology. September 2016 - Volume 31 - Issue 5 - p 483–492.
3 Sannino A, Smith II RL, Schiattarrella GG, et al. Survival and cardiovascular outcomes of patients with secondary mitral regurgitation: a meta-analysis of 53 studies. JAMA Cardiology 2017; 2:1130-39.
4 Goliasch G, Bartko PE, Pavo N, et al. Refining the prognosis impact of functional mitral regurgitation in chronic heart failure. Eur Heart J 2018;39:39-46.
5 Goel SS, Bajaj N, Aggarwal B, et al. Prevalence and outcomes of unoperated patients with severe symptomatic mitral regurgitation and heart failure: comprehensive analysis to determine the potential role of MitraClip for this unmet need. J Am Coll Cardiol. 2014;63:185-6.
6 Dziaddzko et al, "Outcome and Undertreatment of Mitral Regurgitation: a Community Cohort Study", Lancet 2018: 391:960-69.
7 AHA Heart Disease and Stroke Statistics Update, Circulation 2017.
8 Yancy CW, Jessup M, Bozkurt B, et al. 2017 ACC/AHA/HFSA focused update of the 2013 ACCF/AHA /guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Caridol. 2017;70:776-803.
9 Goel SS, Bajaj N, Aggarwal B, et al. Prevalence and outcomes of unoperated patients with severe symptomatic mitral regurgitation and heart failure: comprehensive analysis to determine the potential role of MitraClip for this unmet need. J Am Coll Cardiol. 2014;63:185-6.
10 Pecini et al EHJ 2011; Asgar et al, JACC 2015; Nieminen et al, EHJ 2006; Patel et al, Journal of Cardiac Failure 2004.
11 Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 201;70:252-289.
12 Stone GW, et al. Transcatheter Mitral-Valve Repair in Patients with Heart Failure. N Engl J Med. 2018 Dec 13;379(24):2307-2318.

About Abbott's HeartMate 3 LVAD
Abbott's HeartMate 3 LVAD is a small, implantable mechanical circulatory support device for advanced heart failure patients who are awaiting transplantation or are not candidates for heart transplantation. It is the first commercially approved (CE Mark and FDA approved) LVAD with Full MagLev technology, designed to minimize complications and restore blood flow. The HeartMate 3 system utilizes Full MagLev technology, which allows the device's rotor to be "suspended" by magnetic forces. This design aims to reduce trauma to blood passing through the pump and improve outcomes for patients.

About Abbott's Heart Failure Portfolio
Abbott is pioneering heart failure disease management with innovative solutions like the CardioMEMS HF System, ground-breaking quadripolar pacing technology, our first-to-market MultiPoint pacing technology and, in select European markets and the U.S, the HeartMate 3 left ventricular assist system. Abbott collaborates with heart failure specialists, clinicians and advocacy partners to provide innovative, cost-effective solutions that help reduce hospitalizations and improve patient quality of life for heart failure patients around the world.

For more information about Abbott's focus on heart failure, visit https://www.cardiovascular.abbott/us/en/patients.html.


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