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

Shockwave Launches Coronary Intravascular Lithotripsy in Europe
News | Cath Lab | May 30, 2018
Shockwave Medical recently announced the European commercial availability of Intravascular Lithotripsy (IVL) for...
FFR software on the GE Centricity CVIS. A trial from the 2018 EuroPCR meeting showed FFR improves long-term outcomes.
News | Cath Lab | May 29, 2018
May 29, 2018 — Ongoing controversy exists regarding the role of percutaneous coronary intervention (PCI) for stable c
SCAI Updates Consensus on Length of Stay for Percutaneous Coronary Intervention
News | Cath Lab | May 15, 2018
Revised guidelines incorporating new data on discharge criteria for patients undergoing elective percutaneous coronary...
No Benefit Found Using Sodium Bicarbonate, Acetylcysteine to Prevent Kidney Injury, the result of the PRESERVE Trial to prevent acute kidney injury (AKI), presented at SCAI 2018.  #SCAI, #SCAI2018,
Feature | Cath Lab | May 15, 2018
May 15, 2018 – The large-scale, international randomized PRESERVE clinical trial found high-risk patients for renal c
Angiogram of a STEMI patient.
News | Cath Lab | May 15, 2018
May 15, 2018 — A contemporary, real-world analysis shows lower mortality rates when culprit-only intervention is used
Recent Acquisitions Eroding Prices in Billion Dollar European Interventional Cardiology cath lab Market.
Feature | Cath Lab | May 07, 2018 | Simon Trinh and Jeffrey Wong
The European interventional cardiology market is currently valued at nearly $1.4 billion.
Videos | Cath Lab | May 07, 2018
Imran Ahmad, M.D., medical director of interventional cardiology, explains some of the new technologies his labs have
360 Photos | Cath Lab | April 20, 2018
A 360 degree view of the newest cath lab at Northwestern Medicine Central DuPage Hospital in Winfield, Ill., located
SCAI Announces Global Lecture Series for 2018 Scientific Sessions
News | Cath Lab | April 18, 2018
Many of the world’s leading interventional cardiologists and cardiovascular professionals will convene in San Diego,...
Serial coronary angiograms of the representative case treated with shockwave intravascular lithotripsy.

Figure 1. Serial coronary angiograms of the representative case treated with shockwave intravascular lithotripsy.

Feature | Cath Lab | April 16, 2018 | Azeem Latib, M.D.
Over the last decade, there have been considerable developments in procedural techniques and technology facilitating
Overlay Init