SafePass Trial Evaluates Emboliner Embolic Protection Catheter for TAVR
June 5, 2018—Emboline, Inc. announced the completion of its initial series of human clinical cases using its Emboliner embolic protection catheter, which is designed for use during transcatheter aortic valve replacement (TAVR) procedures. The initial procedures were performed at the Heart Center and the University of Dresden Hospital in Dresden, Germany, as part of the SafePass clinical trial. Professor Axel Linke, MD, who is Chairman of the Department of Internal Medicine and Cardiology at the Heart Center, University of Dresden Hospital, is the SafePass study's Principal Investigator.
The SafePass trial will include up to 60 patients at up to five medical centers in Germany, the Netherlands, and Israel. The trial will assess the safety and technical performance of Emboliner, and the data will be used to submit the device for European CE Mark approval.
According to the company, Emboliner's potential advantages include more effective coverage of all cerebral branches with fewer anatomical limitations; full-body embolic protection, capturing both cerebral and noncerebral debris; no requirement for an additional procedural access; no interference with the TAVR delivery system and accessory devices; and a user-friendly design with minimal added procedural time or complexity.
In the company's announcement, Prof. Linke commented, "Trapping and removing embolic debris during TAVR is especially critical to improving the outcomes of these procedures. We are very encouraged by the initial results we are seeing from the Emboliner device, which has captured embolic debris in every patient in the clinical cases to date. The Emboliner's unique design, which provides full-body embolic protection, is an important addition to the field of TAVR embolic protection."
Emboliner is an investigational device limited by United States law to investigational use, advised Emboline.