Fakultäten » Medizinische Fakultät » Kinderspital Zürich: Medizinische Klinik » Kardiologie, Abteilung » Prof. Dr. Urs Bauersfeld (verstorben) » Kretschmar
| Title / Titel | BioSTAR® ASD Study In Children (BASIC study) | ||
|---|---|---|---|
| Abstract (PDF, 14 KB) | |||
| Summary / Zusammenfassung | BioSTAR® is a new device for interventional closure of atrial septal defect (ASD) and patent foramen ovale (PFO) in children and adults. This septal repair implant has as a completely new feature, in contrast to all other devices, that it is nearly completely bioabsorbable. The membrane of the device is a biological matrix from porcine intestinal collagen layer. The membrane is purified to remove all cells, proteins, and other materials. This membrane is absorbed and replaced by healthy tissue in about two years. Only the small metal frame work will remain. The device has received the CE mark in 2007 and it is now used for the interventional closure of ASD and PFO in adults and children. The BASIC study is a prospective, multi-centre, registry for the evaluation of ASD repair with the BioSTAR® implant in children. This data collection will analyse the hemodynamic impact and safety of ASD closure with BioSTAR®. Data of approximately 200 patients will be collected in about 15 selected centres in Germany, Austria and Switzerland. | ||
| Keywords / Suchbegriffe | BioSTAR® Septal Occluder, atrial septal defect, patent forman ovale, interventional closure, bioabsorbable device | ||
| Project leadership and contacts / Projektleitung und Kontakte |
|
||
| Funding source(s) / Unterstützt durch |
Private Sector (e.g. Industry) NMT Medical, Inc. |
||
| In collaboration with / In Zusammenarbeit mit |
|
||
| Duration of Project / Projektdauer | Oct 2007 to Oct 2009 |