MedAlliance Swiss Medical Technology is an innovative, privately-owned medical technology company specialising in the development and commercialisation of advanced drug-device combination products for the treatment of coronary and peripheral artery disease. The Swiss company has its headquarters in Nyon with further offices located in Germany, the UK, the USA and the Republic of Singapore
With SELUTION DeNovo, MedAlliance Swiss Medical Technology is initiating the largest sirolimus drug-eluting balloon (DEB) study ever conducted: Approximately 3,300 patients will be implanted with the novel DEB compared to a limus drug-eluting stent (DES) at 50 sites in 15 countries. Their goal is to demonstrate non-inferiority at one year as well as superiority at five years for target vessel failure (TVF).
This requires great organisational effort: medical data from the different sites located all over the world must be reviewed, collected, and evaluated. To manage this, MedAlliance relies on ClinFlows’ web-based decidemedical platform, which has been successfully on the market for ten years and is already used in 91 countries worldwide. For good reasons: Via decidemedical, participating sites can upload angiograms in DICOM format and submit them for central review easily and in a GDPR-compliant manner thanks to automated DICOM header pseudonymization.
“For the organisational success of such a large study, it is crucial to have a reliable and stable technology for online image submission. We have used ClinFlows technology in several clinical projects over the past years and are very confident that it will make our job easier this time as well, and uncomplicatedly allow us to comply with all regulatory guidelines in the process.
Pedro Eerdmans, VP Clinical Operations, MedAlliance.
The largest randomised Drug Eluting Balloon trial kicked off back in August, with the first patient enrolled and treated, and the first images uploaded via decidemedical.
“We are very pleased to be able to contribute to such an important clinical trial with our secure and efficient online technology!
Uwe Gladbach, CEO and Founder of ClinFlows.
About ClinFlows
ClinFlows is the leading provider of online solutions to share clinical data and medical images between various stakeholders involved in Clinical Decision Support and Clinical Research. The German company has been connecting medical staff and clinical experts for almost 10 years. Its product portfolio comprises the web-based applications decidemedical, a customizable, powerful platform that simplifies the process of collaborating on clinical cases, and dicomdrop, which offers the possibility to automatically send deidentified and anonymised medical images (DICOM) instantly from A to B. Users in 91 countries worldwide – among others, the leading medical device makers in the cardio-, endo- and neurovascular market – choose ClinFlows’ web-based applications regularly because of their innovative and safe approach. All types of clinical data, as well as large volumes of medical images, are handled in compliance with EU data protection laws, HIPAA and 21 CFR Part 11 requirements.
Press Release MedAlliance relies on ClinFlows’ decidemedical for the world’s largest DEB study
