Abnormalities of the heart's valves and chambers, known as structural heart conditions, threaten millions of lives around the world.1 But life-changing health technologies are enabling structural heart solutions never before imagined – and Abbott is leading the charge past boundaries of what's possible.
As structural heart conditions affect millions of adults and thousands of newborns each year1, 2, the structural heart medical device market represents the largest, fastest-growing cardiovascular device market opportunity today3 – forecast to be $10+ billion by 2025.4
Abbott's $1.1 billion in structural heart sales in 2017 reflects its strength in the market as well as its potential to grow. With one of the largest structural heart device portfolios today, Abbott is committed to advancing its product pipeline through new technologies and therapies that improve how structural heart disease is treated.
The transcatheter mitral repair and replacement market alone is projected to grow from its current $400 million+ value to a multi-billion-dollar opportunity by 2025.4 Abbott's leadership position in mitral repair will continue to grow, having recently won reimbursement approval for its MitraClip device in Japan, adding to the more than 50 countries where MitraClip is in use.
Further, Abbott plans to grow the mitral offering with its Tendyne* and COAPT trials, which will expand the market for transcatheter mitral valve replacement and offer a functional mitral regurgitation repair treatment, respectively. These developments will greatly expand the market and an already strong foothold in mitral leadership for Abbott; they are all expected to launch in the near-term throughout 2019 – 2020.
Our work in the minimally invasive treatment of other heart valves also bears watching: Abbott is working towards a tricuspid heart valve repair offering – leveraging the clip-based technology from its MitraClip product – and will also trial its transcatheter aortic valve repair (TAVR) offering, Portico*, on the U.S. market in 2018.
Beyond valvular solutions, Abbott's structural heart business is a leader in occlusion devices that treat or close openings in the heart caused by congenital heart defects. Abbott's AMPLATZER Amulet* left atrial appendage (LAA) closure product is under clinical trial for the growing U.S. market, and further, Abbott has the first approved product on the U.S. market to treat patent foramen ovale (PFO), or a hole in the heart, with a minimally invasive PFO closure device – AMPLATZER PFO Occluder – that is proven to reduce risk of recurrent stroke in patients with a PFO defect
"We're very optimistic about our structural heart growth franchise and that it's not just a one-year thing; it's a multiple year outlook where we're going to have steady rhythm and cadence," said Brian Yoor, Abbott's chief financial officer.
Solving for unmet needs
New approaches to heart repair are driving Abbott's structural heart portfolio and long-term outlook. Take the MitraClip System, a first-of-its-kind technology for the minimally invasive repair of mitral regurgitation (MR), one of the most common heart valve conditions affecting one in ten people over the age of 755. An alternative for patients at high-surgical-risk, MitraClip is a dependable, effective repair solution that helps adults with mitral regurgitation – estimated to be at 4 million in the U.S. alone – return to better health faster with an improved quality of life. While MitraClip therapy continues to see mounting clinical and real-world evidence of its benefits, three successive generations of MitraClip innovations are planned in 2018, 2019 and 2020.
And though many structural heart issues impact aging adults, more than 71,000 children in the U.S. and European Union combined are born with structural heart defects each year.2
Abbott recently received U.S. Food and Drug Administration approval for a new 15mm pediatric heart valve, the world's smallest mechanical heart valve that allows doctors to treat newborns and babies in need of a mitral or aortic valve replacement.
In the U.S. alone, congenital heart defects (2CHD) affect nearly 1 percent – about 40,000 – births each year. One in four of these babies will have a critical CHD that may require surgery in the child's first year of life.6 With Abbott's pediatric heart valve, children with dysfunctional valves now have the option of receiving Abbott's tiny mechanical heart valve, made to fit the smaller hearts of young infants, that will help them lead a normal life.
To understand just how life-changing this new structural heart solution is, watch the below video of Sadie, the now 3-year-old whose life was saved by Abbott's innovative heart valve technology when she was just a baby and the first infant to be treated as part of the clinical trial for the 15mm valve.
The innovative dime-sized valve builds upon a history of leadership in mechanical valves and the 15mm joins a line of 7 other market-leading replacement mechanical valves sized to fit various child-to-adult anatomies.
What's to come
Abbott continues to break the boundaries of what's possible with first-and-only and relied upon life-changing technology. With structural heart therapies currently in development to provide a transcatheter, minimally invasive treatment offering for various heart valve issues; closure of life-threatening openings and defects of the heart; and relied-upon replacement valves with first-to-world size offerings, Abbott is on a quest to find new and improve existing structural heart solutions to help people live life to the fullest. For us, no structural heart impediment is too big, or too small, to solve.
For U.S. Important Safety Information on MitraClip, visit https://mitraclip.com/#isi.
For U.S. Important Safety Information on AMPLATZER PFO Occluder, please visit https://www.vascular.abbott/content/dam/bss/divisionalsites/av/products/amplatzer-pfo-accluder-isi.pdf.
For U.S. Important Safety Information on the Masters HP Series, visit http://abbo.tt/2taeyVL.
*U.S. Investigational device only.
1. Micro Interventional Devices. Structural Heart Disease. Available https://www.microinterventional.com/structural-heart-disease. Accessed March 14, 2018.
2. Abbott. Structural Heart Disease. Available https://www.sjm.com/en/professionals/disease-state-management/structural-heart-disease. Accessed March 2, 2018.
3. Based on analyst projections including current and future markets.
4. Statistic from Abbott Structural Heart Business.
5. Beumont. Mitral Valve Regurgitation. Available https://www.beaumont.org/conditions/mitral-valve-regurgitation. Accessed March 14, 2018.
6. Centers for Disease Control and Prevention. Congenital Heart Defects. Available https://www.cdc.gov/ncbddd/heartdefects/data.html Accessed February 28, 2018.
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