Following the release in 2006 of what it termed "alarming data" indicating worse long-term prognosis for the implantation of drug-eluting stents compared with bare-metal stents, the European Society of Cardiology (ESC; Sophia Antipolis, France), together with the European Association for Percutaneous Cardiovascular Interventions (EAPCI, also Sophia Antipolis), formed a Task Force On Drug Eluting Safety to address these concerns.
In September 2007, ESC gathered an impressive international panel of experts and stakeholders in the DES controversy for a two-day Forum on Drug Eluting Stents.
Biotronik, Boston Scientific, Cordis and Medtronic each sent the largest delegations of three representatives to the Forum. Two institutions – the Erasmus Medical Center and the French regulator, Agence Française de Sécurité Sanitaire des Produits de Santé sent a similar number of representatives.
The American FDA, the European Medicines Agency and several Notified Bodies who accredited medical devices for the CE mark attended as observers.
The report of findings from the Forum was jointly released by the Task Force in early December in the online editions of EAPCI's EuroIntervention and ESC's European Heart Journal.
Authors of the Report
Representatives from the following institutions signed as authors of the ESC report and also participated in two-day forum:
• Thoraxcenter, Erasmus Medical Center (Rotterdam, the Netherlands).
• Cardiovascular Center, Onze-Lieve-Vrouwziekenhuis Hospital (Aalst, Belgium).
• University of Liverpool, (Liverpool, UK).
• TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital/Harvard Medical School (Boston).
• University of Geneva (Geneva, Switzerland).
• Institut Cardiovasculaire Paris Sud (Massy, France).
• National Heart and Lung Institute, Imperial College (London).
• Clinique Pasteur (Toulouse, France).
• Heidelberg University (Ludwigshafen, Germany).
• Ospedali Riuniti di Bergamo (Bergamo, Italy).
• Trial Coordination Center, Department of Epidemiology, University Medical Center (Groningen, the Netherlands).
• Department of Medical Sciences and Cardiology, Uppsala Clinical Research Center, University Hospital (Uppsala, Sweden).
• Division of Clinical Epidemiology and Biostatistics, Department of Social and Preventive Medicine, University of Bern (Bern, Switzerland).
• Deutsches Herzzentrum (Munich, Germany).
• TÜV SÜD Product Service (Munich, Germany).
• Department of Cardiology, Aarhus University Hospital (Skejby, Denmark).
• Duke University Medical Center, Duke Clinical Research Institute (Durham, North Carolina).
• Centre Hospitalier Universitaire Sart-Tilman (Liége, Belgium).
• Departments of Cardiology, University Hospital (Basel, Switzerland).
• The London Chest Hospital (London).
• Cardiology Practice and Hospital (Munich, Germany).
• Hôpital Bichat (Paris).
• British Standards Institution, Product Services Healthcare (London).
• Bern University Hospital, Department of Cardiology (Bern, Switzerland).
• KEMA Medical (Arnhem,the Netherlands).
• Programs for Assessment of Technology in Health (PATH) Research Institute, St. Joseph's Healthcare Hamilton/McMaster University (Hamilton, Ontario).
Participants in DES Forum
Representatives from the following companies and institutions participated in the Forum on Drug Eluting Stents and contributed to the report:
• Biotronik GmbH & Co. KG (Berlin).
• Boston Scientific (Natick, Massachusetts).
• European Medicines Agency (London)
• Medpole/Neostent (Braine-l'Alleud, Belgium)
• Center for Devices and Radiologic Health, FDA (Rockville, Maryland).
• Abbott Vascular (Santa Clara, California)
• Hexacath (Rueil-Malmaison, France).
• Cordis (Miami Lakes, Florida), a Johnson & Johnson company.
• ClearStream Technologies Group (Wexford, Ireland).
• Sorin Biomedica (Saluggia, Italy).
• Agence Française de Sécurité Sanitaire des Produits de Santé (Paris).
• Medtronic Vascular (Santa Rosa, California)
• Terumo (Tokyo).
• B Braun Medical (Melsungen, Germany).