Funding for this research was provided by:
Heraeus Medical GmbH
Received: 22 November 2018
Accepted: 15 May 2019
First Online: 27 July 2019
Ethics approval and consent to participate
: The clinical investigation plan (CIP), patient’s information sheet and informed consent form, and any other appropriate investigation-related documents were reviewed and approved by an independent ethics committee (IEC) before the start of the clinical investigation ‘Ethikkommission der Landesärztekammer Brandenburg’, Cottbus, Germany; registration number S19(a)/2009).The investigation was conducted in accordance with good clinical practice (GCP) as required by ISO 14155 guidelines, German Medical Devices Act (‘Medizinproduktegesetz’; latest update MPG §§20-23), Council Directive 93/42/EEC, Directive 2007/47/EC, and standard operating procedures (SOPs) for clinical investigation and documentation in force at Heraeus Medical GmbH. Compliance with these requirements also constitutes conformity with the ethical principles of the Declaration of Helsinki.
: Patients were not required to give informed consent to the study because the analysis used anonymous data that were obtained after each patient agreed to treatment by written consent.
: H. Bosebeck and S. Vogt are employees of Heraeus Medical. There were no conflicts of interest that affected the design and execution of the study protocol or the analysis of the data. M. Opalko does not have any conflict of interest to declare.