News | Embolic Protection Devices | June 07, 2018

First TAVR Cases With Emboliner Embolic Protection Catheter Completed

Device provides total embolic protection during TAVR procedures

The Emboliner Embolic Protection Catheteris designed to capture debris released from the valve and vessel walls during transcatheter aortic valve replacement (TAVR) procedures.

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


Related Content

News | Cath Lab

September 13, 2023 — A diagnostic test, first offered in the United States at University Hospitals (UH) Harrington Heart ...

Home September 13, 2023
Home
News | Cath Lab

August 2, 2023 — Teleflex Incorporated, a leading global provider of medical technologies, announced the U.S Food and ...

Home August 02, 2023
Home
News | Cath Lab

July 13, 2023 — Mount Sinai Queens announced the opening of a new cardiac catheterization lab that will provide rapid ...

Home July 13, 2023
Home
News | Cath Lab

June 21, 2023 — Royal Philips, a global leader in health technology, announced it has teamed up with BIOTRONIK (Lake ...

Home June 21, 2023
Home
News | Cath Lab

May 16, 2023 — Royal Philips, a global leader in health technology, announced late-breaking data from the DCR4Contrast ...

Home May 16, 2023
Home
News | Cath Lab

March 14, 2023 — Royal Philips, a global leader in health technology, and the Gibraltar Health Authority, announced they ...

Home March 14, 2023
Home
News | Cath Lab

March 1, 2023 — SpectraWAVE, Inc., a medical imaging company focused on improving the treatment and outcomes for ...

Home March 01, 2023
Home
News | Cath Lab

May 31, 2022 — Innovative Health, LLC, a specialty cardiology reprocessor, announced that the company has received ...

Home May 31, 2022
Home
News | Cath Lab

May 26, 2022 — The U.S. Food and Drug Administration (FDA) has recalled the Dragonfly OpStar Imaging Catheter, and has ...

Home May 26, 2022
Home
News | Cath Lab
April 25, 2022 – NewYork-Presbyterian Hudson Valley Hospital celebrated the launch of its interventional cardiology ...
Home April 25, 2022
Home
Subscribe Now