GAME-CHANGING NEWS FOR HEART HEALTH

Abbott's MitraClip expands patient market as it anchors the Structural Heart portfolio.

Apr 30 2019

One of the fastest-growing pieces of Abbott's medical device portfolio just got another big boost.

The U.S. Food and Drug Administration (FDA) approved a new, expanded indication for our leading MitraClip device used to repair leaky mitral valves without open-heart surgery.

This new indication – based on strong data from a recent clinical study of the product – means the device may be used to treat select heart failure patients with secondary mitral regurgitation (MR) and that two to three times more people will get access to MitraClip's potentially life-saving technology as a result.

The news lifts Abbott's structural heart portfolio even higher, driving the medical technology company's sustainable growth, while at the same time improving lives for heart patients with secondary MR.

"The expanded indication of MitraClip opens new doors for these ailing patients and can improve their chance of survival despite their complex condition," said Neil Moat, M.D., chief medical officer of Abbott's structural heart business. MitraClip is a non-invasive treatment option for patients whose frequent treatment options are either surgery – for which they may be ineligible due to age, frailty and other complications – or medication, which can only mask symptoms.

MitraClip's expanding market

The transcatheter clip-based therapy, available in the U.S. since 2013 has been used to treat more than 80,000 patients worldwide over the last 15 years. That number could grow significantly both from the FDA's decision and as people age around the globe, possibly creating greater need for innovative heart treatments.

Providing new ways to treat common heart problems – called structural heart conditions – remains one of Abbott's most intriguing businesses because these conditions threaten millions of lives around the world.1

Abbott's $1.24 billion in structural heart sales in 2018 reflects its strength in the market as well as its potential to grow3 into a market forecast to be $10+ billion by 2025, making it the fastest-growing cardiovascular device segment.4

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 which is why MitraClip's doubling or tripling market makes it a star of Abbott's structural heart portfolio.

Available in more than 50 countries, MitraClip is now on a third generation of product innovations with additional enhancements planned in 2019 and 2020. Inserted non-invasively through a vein in the leg, the device travels up to the heart via a catheter and clips together a portion of the leaflets of the mitral valve to reduce the backflow of blood, allowing the heart to pump blood more efficiently and improving patient quality-of-life.

"We're very optimistic about our structural heart 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.

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 is also currently conducting a trial of its transcatheter aortic valve replacement (TAVR) offering, Portico™*, in the U.S.

A range of devices for all ages

Beyond valvular solutions, Abbott's structural heart business is a leader in occlusion devices that can help to prevent stroke. Abbott's AMPLATZER™ Amulet™* Left Atrial Appendage (LAA) Occluder product is under clinical trial for the growing U.S. market, and further, Abbott has the leading 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.

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

The recently launched Amplatzer Piccolo™ Occluder, a device approved in the U.S., treats a life-threatening congenital defect called a patent ductus arteriosus, or PDA, which is an opening between two blood vessels leading from the heart that, for most babies, seals itself shortly after birth. When it doesn't, the smaller-than-a-pea Piccolo can offer a life-saving treatment for the smallest patients.

Abbott's MASTERS HP™15mm pediatric heart valve, launched last year, is 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 (CHD) 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.

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 minimally invasive treatment offerings for various heart valve issues; transcatheter closure of life-threatening openings and defects of the heart; and relied-upon replacement surgical 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 about MitraClip, visit https://www.structuralheartsolutions.com/us/mitraclip-isi.

For U.S. Important Safety Information on Amplatzer Piccolo Occluder, visit

https://www.structuralheartsolutions.com/us/piccolo-ISI.

For U.S. Important Safety Information on AMPLATZER PFO Occluder, 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 https://www.vascular.abbott/content/dam/bss/divisionalsites/av/products/valve-sizer-isi.pdf.

* CAUTION: Investigational device. Limited by Federal (U.S.) law to investigational use only.

References

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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