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

New Alliance Announced Between Transcatheter Cardiovascular Therapeutics and VEITHsymposium
News | Cath Lab | June 20, 2019
VEITHsymposium and the Cardiovascular Research Foundation (CRF) announced an alliance between Transcatheter...
Novel Index Accurately Predicts PCI Success Post-Procedure Compared to Established Measurement Metrics
News | Cath Lab | June 19, 2019
Results from a comprehensive analysis demonstrate the effectiveness of measuring a non-hyperemic pressure ratio (NHPR...
Philips Healthcare, Volcano IVUS showing an implanted stent. IVUS might offer an alternative to contrast angiography in patients with acute kidney disease (AKD).
News | Cath Lab | June 14, 2019
June 14, 2019 – A late-breaking study examined the effects of intravascular ultrasound (IVUS) guided drug-eluting ste
Videos | Cath Lab | May 20, 2019
This is a walk through of the primary structural heart hybrid cath lab at...
Mobility May Predict Elderly Heart Attack Survivors' Repeat Hospital Stays
News | Cath Lab | April 23, 2019
Determining which elderly heart attack patients take longer to stand from a seated position and walk across a room may...
FDA Releases New Guidance on Medical Devices Containing Nitinol
News | Cath Lab | April 18, 2019
April 18, 2019 — The U.S.
Angiography shows a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL lithoplasty.

Figure 2: Angiography demonstrates a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification (double-headed arrow) in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL (inset; note the cavitation bubbles generated by IVL [black arrows]). (D) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-IVL and coregistered to the OCT lens (white arrow in C) demonstrate multiple calcium fractures and large acute luminal gain. (E) Angiography demonstrates complete stent expansion with the semicompliant stent balloon (inset) without the need for high-pressure noncompliant balloon inflation. (F) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-stenting and coregistered to the OCT lens (arrow in E) demonstrate further fracture displacement (arrow), with additional increase in the acute area gain (5.17 mm2), resulting in full stent expansion and minimal malapposition.

Feature | Cath Lab | April 15, 2019 | Dean Kereiakes, M.D., FACC, FSCAI, and Jonathan Hill, M.D., DISRUPT CAD III Co-Principal Investigators
Over the last 40 years, despite multiple advancements in percutaneous coronary interventions, calcified lesions remai
BIOTRONIK’s PK Papyrus covered coronary stent. The stent ius used in emergency coronary artery dissections to repair the vessel wall.
Technology | Cath Lab | April 15, 2019
April 15, 2019 — Biotronik began its U.S.
Overlay Init