Abbott Receives European Approval of Heart Devices for Babies and Children
September 17, 2019—Abbott has announced European CE Mark approval for its Masters HP 15-mm rotatable mechanical heart valve and Amplatzer Piccolo occluder. The devices are now available in Europe and other countries that recognize the CE Mark. The devices are already available in the United States.
According to the company, the Masters mechanical heart valve allows doctors to treat babies and toddlers in need of a mitral or aortic heart valve replacement. The Amplatzer Piccolo device, which is smaller than a pea, can be implanted in the tiniest babies (weighing as little as < 1 kg) to treat patent ductus arteriosus.
The 15-mm Masters 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 27 mm.
Prior to the availability of the new device size, surgeons could only replace an irreparable pediatric heart valve with a range of larger-sized valves, 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.
Approved in the United States in January 2019, 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. The device provides corrective treatment for premature infants and newborns who may be nonresponsive to medical management and at high risk to undergo surgery. 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, noted Abbott.
Mario Carminati, MD, Director of Pediatric and Adult Congenital Cardiology at IRCCS Policlinico San Donato in Milan, Italy, commented in the company's announcement, “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.”
advertisement
Featured Video
Conquer the Calcium.
Deliver the Stent.
Sponsored by Cardiovascular Systems Inc.
Related Articles
Top 5 Articles From August 2019
Large-Bore Access Site Management
State-of-the-art closure techniques for large-bore access.
By Amir Kaki, MD; and M. Chadi Alraies, MD
A Tutorial on Ultrasound-Guided Access
Mastering the ultrasound-guided access technique for cardiac and noncardiac interventions can reduce access-related complications and improve outcomes.
By Maarten P. van Wiechen, MD; and Nicolas M. Van Mieghem, MD, PhD, FACC, FESC
How to Close a PFO With ICE Guidance
A guide to understanding intracardiac echocardiography for PFO closure, including available technologies, proper techniques, and potential benefits and limitations.
By Mohamad Alkhouli, MD
Update on Left Atrial Appendage Occlusion
An overview of innovative preprocedural and intraprocedural imaging techniques, trial data, and current LAAO devices and devices in development.
By Saurabh Sanon, MD; and D. Scott Lim, MD
Radial Compression Devices Used After Cardiovascular Interventions
Discussing the design and function of radial artery compression technologies used for a safe closure of radial access after percutaneous cardiovascular intervention.
By Francesco Costa, MD, PhD, FESC; and Renato Scalise, MD
Top 5 from EVToday's Current Issue
What’s New in Y-90?
Technical and procedural innovations in Y-90 radioembolization including existing and investigational next-generation technologies.
By Robert Abraham, MD, FRCPC, FSIR; Robert Lewandowski, MD, FSIR; Ripal T. Gandhi, MD, FSIR, FSVM; and David M. Liu, MD, FRCPC, FSIR
Transradial Access for Hepatic Oncologic Interventions
Considerations for choosing the right access equipment.
By Darren Klass, MBChB, MD, MRCS, FCRC, FRCPC; Anastasia Hadjivassiliou, MBBS, FRCR, FRCPC; and John Chung, MD, FRCPC
Top Tips in Interventional Oncology
Clinical and technical insights into treating hepatocellular carcinoma, cholangiocarcinoma, renal cell carcinoma, lung cancer, bone cancer, and in the palliative care setting.
By Siddharth A. Padia, MD; Theodore Bryan, MD; Rebecca Bennett, MD; Nadine Abi-Jaoudeh, MD, FSIR, CCRP; Raul N. Uppot, MD; Robert Suh, MD; Paul I. Mallinson, MBChB, FRCR, FRCPC; Peter L. Munk, MDCM, FRCPC, FSIR, FFRRCSI (Hon); Miyuki Sone, MD; and Yasuaki Arai, MD, FSIR, FCIRSE
Contemporary Management of Pancreatic Cancer
An update on state-of-the-art minimally invasive therapies, including recent advances in surgery, radiation therapy, ablative options, and endovascular therapies.
By Ripal T. Gandhi, MD, FSIR, FSVM; Horacio Asbun, MD; Michael Chuong, MD; Filipe Kunzler, MD; and Govindarajan Narayanan, MD
Is It Time to End the Therapeutic Nihilism Toward Treating VTE in Cancer Patients?
Cases highlighting the potential for early benefit and improved quality of life and function associated with the use of FlowTriever and ClotTriever Systems in patients with cancer and VTE.
