Implants suitable for children are rare., Wolfram Scheible für Nationales Register © Wolfram Scheible für Nationales Register
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Press Release: Medicine and Healthcare

Pacemakers: Too Expensive for a Child?

Health Professionals and Patients' Associations are Raising Alarm

An urgent letter was sent to the manufacturers of pacemakers, defibrillators, cardiac catheters and pharmaceuticals, as well as the Federal Minister of Health, Jens Spahn, by physicians, patients and researchers of the research network "Competence Network for Congenital Heart Defects". For what reason? Medical devices and pharmaceuticals suited for children are increasingly lacking.

In April 2018, six-year-old Nelly from Homburg was implanted with the world's smallest pacemaker at the Saarland university hospital. The little patient was born with congenital heart disease and a very low heart-rate. What she received was the last remaining pacemaker suitable for children the department of pediatric cardiology had in stock. The manufacturer of medical devices had stopped the production of named device.

Scarcity of Suitable Medical Devices is Unethical

This is not an isolated case, as Hashim Abdul-Khaliq, Medical Director of the department of pediatric cardiology at the Saarland university hospital and Speaker of the Competence Network for Congenital Heart Defects, informs us. „Such decisions affect all the pediatric heart centers across the nation.“ It is true that the implantation of a pacemaker in premature babies and newborns occurs only rarely. However, it saves lives if needed. Due to implants suitable for children being scarce, pediatric cardiologists and pediatric heart surgeons are forced to use medical devices that were developed for adults. And this is a major problem: "Those devices are not suitable for children and therefore pose a health hazard to them. This cannot be justified for both medical and ethical reasons. Medical devices that meet the specific requirements of the bodies of children with congenital heart disease are crucial to ensure their survival and quality of life.

An Urgent Call to Politics and Economy

With an urgent letter, physicians, researchers and patients' associations of the Competence Network for Congenital Heart Defects called on those in charge in politics and economy to warrant targeted research funding and the production of respective medical devices and pharmaceuticals. The signatories of the letter base their plea on the German Basic Law. "According to article 2 of our constitution, every person shall have the right to life and physical integrity. Manufacturers' decisions such as the one described jeopardize the service to each individual's health, which is both necessary and self-evident. Society obliges us to do everything in our power to relieve this deficit," Sven Dittrich, President of the Deutsche Gesellschaft fuer Paediatrische Kardiologie (German Society for Pediatric Cardiology, DGPK) reasons.

One in One Hundred Children is Affected

One in one hundred children in Germany is born with congenital heart disease. Thanks to advancements in diagnostics and treatment that started in the seventies, over ninety percent of those affected reach adulthood today. However, living with a chronic illness requires continuous medical care. Many open questions regarding the causes and the long-term course of congenital heart disease are yet to be answered in order to ensure these patients to be provided with ideal healthcare. This includes researching on and developing medical devices suitable for children. Patients' associations deem an appropriate political framework a solution approach: "A EU Directive has created incentives and sanctions for the researching industry in the drug discovery and development of children's pharmaceuticals," says Kai Rüenbrink, Speaker of the Aktionsbuendnis Angeborene Herzfehler ("Coalition for Congenital Heart Disease"). According to him, such measures are urgently needed in the field of artificial heart valves, stents, catheters and other medical devices.


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