Group Finds Excellent Clinical Results and Expanded Enrollment in OCCLUDE I Study
ArtVentive Medical Group, Inc. announced excellent clinical results in conjunction with expanded enrollment in the ArtVentive Endoluminal Occlusion System, or ArtVentive EOS™ device, OCCLUDE I post-market surveillance study.
The Department of Interventional Radiology and Neuroradiology, Medical University of Lublin, Poland reported successful results for eleven cases over a two-day period. Professor Tomasz Jargiello served as the Primary Investigator and Professor Malgorzata Szczerbo-Trojanowska, head of the Department, Dr. Krzysztof Pyra and Dr. 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 varicoceles using the ArtVentive EOS™ device.
“The ArtVentive EOS™ device performed extremely well and met all expectations in a clinical setting,” Dr. Jargiello stated. “I was able to deliver the device with ease to the desired site and I was impressed with its simple deployment. The ArtVentive EOS™ 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 ArtVentive EOS™ system. Approximately eighty patients will be enrolled at up to ten study sites worldwide in the coming months,” said Dr. Leon Rudakov, President and Chief Technology Officer.
Jim Graham, ArtVentive’s Chief Executive Officer said, “It is gratifying that these cases have continued to validate our innovation and efforts over the past several years. The ArtVentive EOS™ platform offers significant clinical benefits and we look forward to gaining additional valuable insights from the OCCLUDE studies and expanding ArtVentive EOS™ platform’s market potential.”