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: www.tvamedical.com
 
References

 
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

Nuance Communications Inc. introduced Nuance Cardiovascular CAPD, a new computer-assisted physician documentation (CAPD) solution designed to help cardiologists improve the quality of complex documentation and the accuracy of reimbursement for cardiac catheterization procedures. The Nuance Cardiovascular CAPD solution is available through a partnership with ZHealth for this solution, which is based on patented algorithms built with ZHealth’s interventional documentation and coding expertise.
News | Cath Lab | January 31, 2020
January 29, 2020 – Nuance Communications Inc.
Videos | Cath Lab | January 09, 2020
Haval Chweich, M.D., medical director of the cardiac critical care unit (CCU) at Tufts Medical Center, and assistant...
People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.  In early December 2019, leaders of the European Association for Cardiothoracic Surgery (EACTS) withdrew their support for European practice guidelines that endorse the use of coronary stents in many patients with left main coronary artery disease.

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.

News | Cath Lab | January 02, 2020 | Dave Fornell, Editor
January 2, 2020 — In early December 2019, leaders of the European As...
News | Cath Lab | December 18, 2019
December 18, 2019 — Cook Medical initiated a recall of its CrossCath Support Catheters in November, which the U.S.
Gallery | Cath Lab | October 31, 2019 | Dave Fornell, Editor
This is a photo essay of the interventional cardiology and structural heart technologies on the expo floor and discus
The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

Technology | Cath Lab | October 28, 2019
Office based labs (OBLs) and ambulatory surgery centers (ASCs) require a fresh perspective from imaging vendors.
Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

News | Cath Lab | October 28, 2019
October 28, 2019 — Leaders within University Hospitals and the Harrington Heart and Vascular Institute had a vision t
OmniVision Announces Guinness World Record for Smallest Image Sensor

OmniVision's OVM6948 CameraCubeChip, a fully packaged, wafer-level camera module measuring 0.65mm x 0.65mm x 1.158mm, built on OmniVision's OV6948, winner of the Guinness World Record for “The Smallest Image Sensor Commercially Available.”

News | Cath Lab | October 22, 2019
October 22, 2019 — OmniVision Technologies Inc.
Overlay Init