The Emboliner Embolic Protection Catheter is designed to capture debris released from the valve and vessel walls during transcatheter aortic valve replacement (TAVR) procedures. It allows for the passage of other catheters during TAVR procedures.
June 7, 2018 — The first clinical cases have been completed where the Emboliner Embolic Protection Catheter was used 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.
Cerebral embolism, which can lead to stroke or death, is a known complication of TAVR. In carefully controlled studies, stroke rates related to TAVR have been shown to be as high as 27 percent. This has led to the development of several types of aortic embolic protection systems to prevent strokes.
The SafePass trial will include up to 60 patients at up to five medical centers throughout Germany, the Netherlands and Israel. The trial will assess the safety and technical performance of the Emboliner and the data will be used to submit the device for European CE mark approval.
"Trapping and removing embolic debris during TAVR is especially critical to improving the outcomes of these procedures," said Prof. Dr. Axel Linke, the SafePass principal investigator and chairman of the Department of Internal Medicine and Cardiology at the Heart Center, University of Dresden Hospital. "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."
The novel Emboliner device is intended to not only provide more reliable cerebral embolic protection, but also complete protection of the arterial bed (both cerebral and non-cerebral vessels) utilizing a ported design that maintains tool access through the filter. The company said the device offers several improvements over first-generation TAVR embolic protection solutions. The Emboliner has been designed to offer several potential advantages, including:
• More effective coverage of all cerebral branches with fewer anatomical limitations
• Full-body embolic protection, capturing both cerebral and non-cerebral debris
• No requirement for an additional procedural access
• No interference with the TAVR delivery system and accessory devices
• An extremely user-friendly design with minimal added procedural time or complexity
Emboline Inc. is a privately-held, emerging medical device company. Use of the device is limited under United States law to investigational use only.
For more information: www.emboline.com