ArtVentive has announced positive clinical results in conjunction with expanded enrolment in the ArtVentive Endoluminal Occlusion System (EOS device) OCCLUDE I post-market surveillance study.
The Department of Interventional Radiology and Neuroradiology, Medical University of Lublin, Poland, has reported successful results for eleven cases over a two-day period. Tomasz Jargiello served as the primary investigator and Malgorzata Szczerbo-Trojanowska, head of the Department, Krzysztof Pyra and Michal Sojka each participated in the study. In conjunction with the study, four female patients were treated for pelvic congestion syndrome and seven male patients were treated for varicocoeles using the ArtVentive EOS device.
“The ArtVentive EOS device performed extremely well and met all expectations in a clinical setting,” Jargiello stated. “I was able to deliver the device with ease to the desired site and I was impressed with its simple deployment. The device provided instant and complete occlusion of the target site. This is an improvement over other currently available occlusion devices and provided our team with confidence that the desired embolization was achieved.”
“The OCCLUDE I venous and OCCLUDE II arterial post-market surveillance studies will compound our growing knowledge of the efficacy of the ArtVentive EOS device in vascular embolization treatments, expanding the already strong clinical application for the system. Approximately eighty study patients will be enrolled at up to ten study sites worldwide in the coming months,” said Leon Rudakov, president and Chief Technology Officer.