News | Vascular Access | October 04, 2017

TVA Medical Receives CE Mark for Next-Generation EverlinQ 4 EndoAVF System

4 French catheter system creates an endovascular hemodialysis access with a streamlined procedure

TVA Medical Receives CE Mark for Next-Generation EverlinQ 4 EndoAVF System

October 4, 2017 — TVA Medical Inc. announced that its everlinQ 4 endoAVF System has received CE Mark in the European Union. The technology uses a 4 French catheter system with enhanced visual indicators to create hemodialysis access using an endovascular technique without open surgery.

In a prospective, single arm, single-center study evaluating the everlinQ 4 endoAVF System, 97 percent of endovascular arteriovenous fistula  (endoAVF) procedures were successful, and fistula maturation was achieved in 83 percent of patients.

Tobias Steinke, M.D., chief of vascular and endovascular surgery, Schön Klinik, Düsseldorf, Germany,performed the first case in Europe using the everlinQ 4 System. “The new system with smaller profile catheters and radiopaque visual indicators was extremely easy to use,” he said. “This new approach streamlines the procedure for providing patients a functional AV fistula without open surgery.”

Each year approximately 3 million people worldwide with end-stage renal disease (ESRD) are treated with hemodialysis.1 However, the first step, creating a viable access in the arm, is often a significant clinical challenge. The current standard approach, surgical arteriovenous fistulas (AVFs), are associated with high failure rates2, and may require frequent revisions, impacting patient quality of life and resulting in unnecessary costs.3

The everlinQ endoAVF System, using the 4 French or 6 French catheter system, is designed to create an AVF for hemodialysis access using an endovascular approach. In the procedure, two thin, flexible magnetic catheters are inserted into an artery and vein in the arm. A small amount of radiofrequency energy is used to connect the artery and vein to create the fistula. The catheters are then removed and a brachial vein is coil-embolized, enabling future dialysis.  

The 6 French everlinQ endoAVF System previously received CE marking for ESRD patients who need hemodialysis. The 6 French system also has Health Canada Medical Device License. TVA Medical is pursuing U.S. Food and Drug Administration (FDA) clearance of the everlinQ endoAVF System and the technology is not currently available for use in the United States.

For more information:

1 Liyanage, et al.  Lancet, 2015. 10.1016/S0140-6736
2 Al-jaishi, et al.  Am J Kidney Dis 2014;63:464-78.
3 Lok. Clin J Am Soc Nephrol 2: 1043-1053, 2007.

Related Content

Videos | Cath Lab | March 15, 2018
A discussion with Hitinder Gurm, M.D., MBBS, FACC, professor, internal medicine, and associate chief clinical officer
News | Cath Lab | February 27, 2018
The American College of Cardiology (ACC) and the Saudi Arabian Cardiac Interventional Society have partnered to...
News | Cath Lab | February 23, 2018
February 23, 2018 — CorFlow Therapeutics AG announced that the company will present new insights into the coronary mi
Teleflex Launches Next-Generation Sympro Elite and Expro Elite Snares
Technology | Cath Lab | February 07, 2018
Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch...
SCAI Advocacy Committee Highlights Reimbursement Reform Efforts in 2017
News | Cath Lab | January 30, 2018
The Society for Cardiovascular Angiography and Interventions (SCAI) highlighted the efforts of its Advocacy Committee...
IAC Releases Cardiovascular Catheterization Accreditation Program
News | Cath Lab | January 25, 2018
January 25, 2018 – The Intersocietal Accreditation Commission (IAC) announced the release of its Cardiovascular Cathe
Videos | Cath Lab | January 04, 2018
Bernadette Speiser, BSN, MSN, CCRN, RCIS, a cardiac cath/EP nurse at Palo Alto Veterans Hospital, Palo Alto, Calif.,
FDA Initiates Class I Recall of Sterilmed Reprocessed Agilis Steerable Introducer Sheath
News | Cath Lab | January 04, 2018
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer...
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA system. 

Feature | Cath Lab | November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Overlay Init