Feb 1, 2018   SOURCE: PR NewsWire

Meta-Analysis Demonstrates Positive Clinical Experience Using everlinQ(TM) endoAVF System For Hemodialysis Access

LEIPZIG, Germany, Feb. 1, 2018 /PRNewswire/ -- An international meta-analysis of clinical experience in patients who received an endovascular arteriovenous fistula (endoAVF) for hemodialysis access was presented today at Leipzig Interventional Course (LINC) 2018. The meta-analysis, which analyzed data from 236 patients with end-stage renal disease (ESRD) at 28 centers across seven countries, demonstrated positive clinical results using the everlinQ(TM) endoAVF System from TVA Medical, Inc.

The everlinQ endoAVF System received European CE Mark in 2014 and Health Canada Medical Device License in 2016 for ESRD patients. It is not available for sale in the United States and is currently under review by the U.S. Food and Drug Administration.

The results were presented in a main arena discussion by Dr. Tobias Steinke, Chief of Vascular and Endovascular Surgery at Schoen Hospital in Düsseldorf, Germany. According to Dr. Steinke: "Our meta-analysis from four clinical studies and real-world experience across three continents supports the use of the everlinQ endoAVF System as a valuable hemodialysis access option without open surgery."

The meta-analysis included four clinical studies with pooled efficacy and safety data from 157 and 125 patients, respectively, using both the 4 Fr or 6 Fr versions of the everlinQ catheter system, as well as data from 79 commercial cases, using the 6 Fr catheter system. The following results were demonstrated:

    --  96.8% and 97.8% procedure success rate in the clinical study population
        and real-world cases, respectively, with an acceptable safety profile;
    --  88% fistula maturation at three months among evaluable subjects from the
        clinical studies; and
    --  74.8% of patients from the study population and 90% in the real-world
        cases were successfully cannulated by 6 months.

In addition, the following Kaplan-Meier estimates were reported:

    --  74.8% primary patency - or unobstruction without additional intervention
        - at 12 months in the clinical study patients;
    --  79% secondary patency - or unobstruction - at 12 months in the clinical
        study patients; and
    --  98.2% functional patency - durability post-cannulation - at 12 months in
        the clinical study patients.

Following the meta-analysis data presentation, Dr. Robert Jones, Consultant Interventional Radiologist at Queen Elizabeth Hospital in Birmingham, England, presented on a recorded patient case he performed using the everlinQ(TM) 4 endoAVF System. The everlinQ 4 endoAVF System, which received CE Mark in 2017, uses a 4 Fr catheter system to create an endovascular fistula. "I am very pleased with the utility and patient outcomes I've experienced to date with the new 4 Fr everlinQ endoAVF System," said Dr. Jones. "I am excited to have an endovascular option to offer patients."

Each year approximately 3 million people worldwide with 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 AVFs, are associated with high failure rates(2) and they require frequent revisions.(3,4 )

About the everlinQ endoAVF System
The everlinQ endoAVF System, using a 4 Fr or 6 Fr 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 everlinQ endoAVF System, using the 6 Fr and 4 Fr catheter systems, has received marketing approval in Europe (CE Mark) and Canada. The everlinQ endoAVF System is not commercially available in the United States and the 6 Fr catheter system is currently under review by the U.S. Food and Drug Administration.

About TVA Medical
TVA Medical, Inc., headquartered in Austin, Texas, is developing minimally invasive therapies for end-stage renal disease and other potential applications, such as peripheral vascular disease. More information is available at www.TVAMedical.com.

(1) Liyanage,T. et al. Worldwide access to treatment for end-stage kidney disease: a systematic review. Lancet, 2015. 10.1016/S0140-6736.
(2 )Al-jaishi, A. et al. Patency Rates of the Arteriovenous Fistula for Hemodialysis: A Systematic Review and Meta-analysis. Am J Kidney Dis 2014;63:464-78.
(3) Lok, C. Fistula First Initiative: Advantages and Pitfalls.Clin J Am Soc Nephrol 2: 1043-1053, 2007.
(4) Falk A. Maintenance and salvage of arteriovenous fistulas. J Vasc Interv Radiol. 2006;17(5):807-13

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SOURCE TVA Medical, Inc.