Abbott's Amplatzer Piccolo™ Delivery System Receives FDA Clearance and CE Mark to Optimize Procedures for Premature Babies With a Hole in the Heart

Abbott (NYSE: ABT) announced FDA clearance and CE Mark for the Amplatzer Piccolo Delivery System to be used with the Amplatzer Piccolo Occluder to treat patent ductus arteriosus (PDA) in premature infants.

Rhea-AI Summary

Abbott (NYSE: ABT) announced FDA clearance and CE Mark for the Amplatzer Piccolo Delivery System to be used with the Amplatzer Piccolo Occluder to treat patent ductus arteriosus (PDA) in premature infants.

The delivery system is designed for the tiniest babies (some as small as ~2 pounds), enables single-catheter procedures, and aims to improve placement precision and reduce adverse events. The Amplatzer Piccolo Occluder was previously approved in 2019. The announcement highlights Abbott's pediatric structural heart portfolio and provides links for important safety information.

Positive

• FDA clearance and CE Mark obtained (Dec 18, 2025)
• Enables treatment for infants as small as ~2 pounds
• Procedure simplified to a single-catheter technique
• Designed to improve device positioning and reduce adverse events
• Amplatzer Piccolo Occluder previously approved in 2019

Negative

• None.

Argus Dec 18 session

-1.25% close to close Open Argus

Details

News Market Reaction – ABT

In the Dec 18 session, ABT declined 1.25%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights FDA clearance and CE Mark for Abbott’s Amplatzer Piccolo Delivery Syste...

Analysis

This announcement highlights FDA clearance and CE Mark for Abbott’s Amplatzer Piccolo Delivery System, designed for premature infants with patent ductus arteriosios, a serious congenital heart condition affecting about 20% of premature babies requiring treatment. It builds on the 2019 approval of the Amplatzer Piccolo Occluder and complements other pediatric devices like the Masters HP 15mm valve. Investors may track adoption trends, safety outcomes, and how this strengthens Abbott’s structural heart franchise.

Key Figures

PDA treatment rate: 20% of premature infants Lowest infant weight: Two pounds Piccolo approval year: 2019 +1 more

PDA treatment rate

20% of premature infants

Premature infants with PDA requiring treatment

Lowest infant weight

Two pounds

Premature babies eligible for Piccolo delivery system

Piccolo approval year

2019

FDA approval and CE Mark for Amplatzer Piccolo Occluder

Masters HP valve size

15mm

Masters HP 15mm mechanical heart valve for pediatric patients

Historical Context

5 past events · Latest: Dec 12

5 events

1. Dec 12

   Dividend increase

   24h Move

   +1.8%

   Raised quarterly dividend by 6.8%, extending 54-year growth streak.

2. Dec 08

   Product expansion

   24h Move

   -2.4%

   Lingo glucose monitoring expanded to Android for broader access.

3. Dec 06

   CSR initiative

   24h Move

   -2.4%

   Blood drive campaign lifted donations 319%, supporting up to 250,000 lives.

4. Dec 04

   Nutrition launch

   24h Move

   +0.1%

   Launched two Ensure Max Protein shakes targeting muscle health demand.

5. Nov 20

   Large acquisition

   24h Move

   -1.7%

   Announced ~$21B acquisition of Exact Sciences to expand cancer diagnostics.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

patent ductus arteriosus, FDA clearance, CE Mark, transcatheter, +1 more

5 terms

patent ductus arteriosus medical

"premature infants with a patent ductus arteriosus (PDA), a life-threatening"

A congenital heart condition where a blood vessel that normally closes soon after birth stays open, letting extra blood flow between two major arteries; imagine a door that should have shut after a baby is born but remains ajar and forces the heart and lungs to work harder. It matters to investors because the condition drives demand for specific drugs, medical devices and procedures, and outcomes from clinical trials or regulatory approvals can directly affect companies’ revenues and valuations.

FDA clearance regulatory

"announced it has received U.S. Food and Drug Administration (FDA) clearance and"

FDA clearance is the U.S. Food and Drug Administration’s official permission to market certain medical devices or diagnostic tests after reviewing evidence that they are as safe and effective as similar products already on the market. For investors, it’s like a product passing a required safety inspection — it reduces regulatory uncertainty, speeds commercial rollout, and can directly affect sales prospects, valuation, and partnership opportunities.

CE Mark regulatory

"received U.S. Food and Drug Administration (FDA) clearance and CE Mark for its"

A CE mark is a regulatory stamp placed on products to show they meet the European Union’s basic safety, health and environmental rules and can be sold in the European Economic Area. For investors it matters because the mark unlocks market access, affects how quickly a product can generate revenue, and signals regulatory risk and potential compliance costs—think of it as a passport that lets a product enter a large market.

transcatheter medical

"only minimally invasive, transcatheter treatment approved to close a PDA in"

Transcatheter describes medical procedures or devices delivered through a thin, flexible tube (catheter) that is threaded through blood vessels or small body openings to reach the heart or other organs without open surgery. It matters to investors because transcatheter approaches enable faster recovery, shorter hospital stays and larger patient pools for treatments that once required major operations, which can expand market demand and affect device and hospital revenues.

mechanical heart valve medical

"includes the world's smallest mechanical heart valve, the Masters HP™ 15mm,"

A mechanical heart valve is an artificial device surgically implanted to replace a damaged natural heart valve; think of it as a long-lasting metal or ceramic hinge that keeps blood flowing in the right direction. It matters to investors because these implants drive sales, regulatory approvals, and ongoing healthcare spending, while also carrying important risks and costs—notably the need for lifelong blood-thinning drugs and follow-up care—which affect manufacturers’ revenues and healthcare payers’ outlays.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

• First and only delivery system designed specifically for premature infants with a patent ductus arteriosus (PDA), a life-threatening opening in their heart
• New delivery system enables precise placement of Abbott's Amplatzer Piccolo Occluder in the tiniest babies
• A PDA requiring treatment is present in approximately 20% of premature infants¹

ABBOTT PARK, Ill., Dec. 18, 2025 /PRNewswire/ -- Abbott (NYSE: ABT) today announced it has received U.S. Food and Drug Administration (FDA) clearance and CE Mark for its Amplatzer Piccolo™ Delivery System, which is used with the company's Amplatzer Piccolo Occluder. The new delivery system is designed specifically to treat premature babies (some weighing as little as two pounds) with a hole in the heart known as a patent ductus arteriosus (PDA).

A PDA is an opening between two blood vessels in an infant's heart that fails to close as it should following birth. Before a baby is born, this channel allows blood to bypass the not-yet-functioning lungs because the fetus gets oxygen-rich blood from the mother. If the hole remains open after birth, it changes the flow pattern so additional blood is directed to the lungs, making it difficult for babies to breathe normally.

"Abbott's new Amplatzer Piccolo Delivery System is a transformative step forward in how we treat PDA in premature infants," said Evan Zahn, M.D., professor of cardiology and pediatrics and director of the Guerin Family Congenital Heart Program at Cedars-Sinai Medical Center in Los Angeles, Calif. "The new delivery system simplifies the implant procedure because only one catheter is needed instead of multiple, and a shorter and softer design allows for more precise device positioning in these tiny babies. Doctors can treat this group with more confidence, reducing the risk of adverse events and improving the long-term outlook for this uniquely vulnerable patient population." 

The Amplatzer Piccolo Occluder is smaller than a pea and is the world's first and only minimally invasive, transcatheter treatment approved to close a PDA in premature infants with this common congenital heart defect. The Amplatzer Piccolo device is inserted through a small incision in the infant's leg and guided through vessels to the heart using the Amplatzer Piccolo Delivery System, where it is placed to seal the opening in the heart. The Amplatzer Piccolo Occluder received FDA approval and CE Mark in 2019.

"We designed the Amplatzer Piccolo Delivery System based on feedback from leading physicians across the world to make PDA closure procedures even safer and easier," said Sandra Lesenfants, senior vice president of Abbott's structural heart business. "With the Amplatzer Piccolo Occluder, which is the world's smallest heart device, and now with the new delivery system to complement it, we're continuing to advance how we meet the needs of our tiniest patients with structural heart disease."

Abbott's portfolio of pediatric heart therapies also includes the world's smallest mechanical heart valve, the Masters HP™ 15mm, and the HeartMate 3™ heart pump, which is approved for pediatric patients. Abbott is continuing to develop lifesaving pediatric devices that have an immediate impact with long-term benefits, reduce the risks of life-threatening complications and allow physicians to confidently treat the youngest and tiniest patients.

For U.S. important safety information on the Amplatzer Piccolo Delivery System, visit https://abbo.tt/PDS_ISI.

For U.S. important safety information on the Amplatzer Piccolo Occluder, visit https://abbo.tt/PiccoloISI.

For U.S. Important Safety Information about the Masters HP 15mm valve, visit https://abbo.tt/MastersISI.

For U.S. Important Safety Information about the HeartMate 3, visit https://cardiovascular.abbott/hm3isw.

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 114,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube. 

¹ emedicine. April 1, 2025. Patent Ductus Arteriosus. https://emedicine.medscape.com/article/891096-overview. 

 

View original content:https://www.prnewswire.com/news-releases/abbotts-amplatzer-piccolo-delivery-system-receives-fda-clearance-and-ce-mark-to-optimize-procedures-for-premature-babies-with-a-hole-in-the-heart-302645632.html

SOURCE Abbott

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Abbott announce about the Amplatzer Piccolo Delivery System (ABT) on Dec 18, 2025?

Abbott announced FDA clearance and CE Mark for the Amplatzer Piccolo Delivery System to treat PDA in premature infants.

How small are the premature babies who can be treated with Abbott's new delivery system (ABT)?

The delivery system is designed to treat premature infants weighing as little as about 2 pounds.

How does the Amplatzer Piccolo Delivery System change the PDA procedure for ABT patients?

It allows a single-catheter approach with a shorter, softer design for more precise device placement.

Is the Amplatzer Piccolo Occluder already approved (ABT)?

Yes. The Amplatzer Piccolo Occluder previously received FDA approval and CE Mark in 2019.

What clinical problem does Abbott's Amplatzer Piccolo solution address (ABT)?

It treats patent ductus arteriosus (PDA), a life‑threatening opening in the heart present in about 20% of premature infants.

Where can investors find safety information for Abbott's Amplatzer Piccolo devices (ABT)?

U.S. important safety information is available via the company's provided device-specific links in the announcement.