News | Congenital Heart | September 20, 2019

Abbott Receives European CE Mark for Two Pediatric Heart Devices

Masters HP 15mm rotatable mechanical heart valve and Amplatzer Piccolo Occluder now available in Europe and other countries that recognize CE Mark

Abbott Receives European CE Mark for Two Pediatric Heart Devices

September 20, 2019 – Abbott announced approvals in Europe for two of its pediatric devices — the Masters HP 15mm rotatable mechanical heart valve and the Amplatzer Piccolo Occluder. Both devices have received CE Mark and are now available in Europe and other countries that recognize CE Mark. The new treatments, already available in the U.S., offer young pediatric patients and their families hope when no other suitable treatment option may exist.

Congenital heart defects (CHD) affect approximately 36,000 births in the European Union each year[1]. Abbott calls the Masters valve the world's smallest mechanical heart valve, allowing doctors to treat babies and toddlers in need of a mitral or aortic heart valve replacement. The Amplatzer Piccolo is smaller than a pea and is the world's first medical device that can be implanted in the tiniest babies (weighing as little as under one kilogram) to treat patent ductus arteriosus (PDA), a potentially life-threatening opening in the heart. 

The Masters valve is the first and only pediatric mechanical heart valve developed for newborns and infants, according to Abbott. The valve is a rotatable, bileaflet mechanical heart valve designed for implantation in the mitral or aortic position and is part of the Masters Series line, which now includes seven valves with diameter sizes ranging from 15 to 27mm. 

When the tissues of the heart valve have a significant malformation or are too damaged and cannot be repaired to function properly, it may be necessary to replace the valve with a mechanical valve. A mechanical heart valve mimics a healthy heart valve, opening and closing with each heartbeat, permitting proper blood flow through the heart.

Until Abbott's device, surgeons could only use a range of larger-sized valves to replace a pediatric heart valve that could not be repaired, which could result in improper fit and complications. The Masters pediatric valve was approved in the United States in March 2018 and in Canada in October 2018.

The Amplatzer Piccolo, approved in the U.S. in January 2019, is indicated to treat PDA, one of the most common congenital heart defects occurring in premature babies that creates a potentially life-threatening opening between two blood vessels which lead from the heart.This channel, which is present in normally developing fetuses, is important prior to birth to allow oxygen-rich blood from the mother to circulate throughout the fetus' body. For most infants, the pathway, or duct, seals itself shortly after birth. In some cases, primarily in babies born prematurely, the PDA fails to spontaneously close, which can make it difficult for babies to breathe normally due to increased blood flow to the lungs. PDA accounts for up to 10 percent of all congenital heart disease[2].

The Amplatzer Piccolo is a self-expanding, wire mesh device that is inserted through a small incision in the leg and guided through vessels to the heart, where it is placed to seal the opening in the heart. Many of the premature babies who are critically ill in the neonatal intensive care unit are able to be weaned from artificial respirator support soon after the minimally invasive procedure.  

“Seeing the youngest patients fight for their lives is harrowing, and finally having solutions that can offer a dependable treatment option to get these little ones out of the NICU and sent home with their families is a huge advance in our field,” said Mario Carminati, M.D., director of pediatric and adult congenital cardiology at IRCCS Policlinico San Donato, Milan, Italy.

For more information: www.abbott.com

 

References

1. Dolk H., Loane M., Game E., et al. Congenital heart defects in Europe: prevalence and perinatal mortality, 2000 to 2005.” Circulation 123 8 (2011): 841-9.

2. Schneider D.J., Moore J.W. (2006). Patent ductus arteriosus. Circulation, 114(17), 1873-18.

Related Content

Gallery | Cath Lab | October 31, 2019
This is a photo essay of the interventional cardiology and structural heart technologies on the expo floor and discus
The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

Technology | Cath Lab | October 28, 2019
Office based labs (OBLs) and ambulatory surgery centers (ASCs) require a fresh perspective from imaging vendors.
Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

News | Cath Lab | October 28, 2019
October 28, 2019 — Leaders within University Hospitals and the Harrington Heart and Vascular Institute had a vision t
OmniVision Announces Guinness World Record for Smallest Image Sensor

OmniVision's OVM6948 CameraCubeChip, a fully packaged, wafer-level camera module measuring 0.65mm x 0.65mm x 1.158mm, built on OmniVision's OV6948, winner of the Guinness World Record for “The Smallest Image Sensor Commercially Available.”

News | Cath Lab | October 22, 2019
October 22, 2019 — OmniVision Technologies Inc.
People watch the presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., live in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long term surgical outcomes. #TCT2019

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes. 

Feature | Cath Lab | October 03, 2019
October 3, 2019 – Five-year data from the EXCEL Trial showed patients with left main coronary disease treated with pe
Two Stents Implanted in Democratic Presidential Candidate Bernie Sanders, suffers chest pain
News | Cath Lab | October 02, 2019 | Dave Fornell, Editor
October 2, 2019 — Democratic presidential candidate Sen.
Bypass Surgery and Coronary Stenting Yield Comparable 10-Year Survival
News | Cath Lab | September 25, 2019
Ten-year survival rates are similar for bypass surgery and coronary stenting with drug-eluting stents in randomized...
Complete Revascularization Superior to Culprit Lesion-only Intervention
News | Cath Lab | September 10, 2019
An international randomized trial has shown that complete revascularization reduces major cardiovascular events...
The cath lab staff UH Portage Medical Center.

The cath lab staff UH Portage Medical Center.

Feature | Cath Lab | September 09, 2019 | Anjan Gupta, M.D., FACC, FSCAI
Primary percutaneous coronary intervention (PCI) is the preferred treatment for acute...
Overlay Init