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November 3, 2015

NEAT Evaluates TVA Medical's everlinQ System for Creating Endovascular Arteriovenous Fistula

November 3, 2015—Charmaine E. Lok, MD, presented preliminary results from the Novel Endovascular Access Trial (NEAT) during the second of two Late-Breaking Trials sessions at VIVA 15, the 13th annual Vascular InterVentional Advances meeting. The meeting, which is sponsored by VIVA Physicians, Inc., is being held November 2–5, 2015, at the Wynn Las Vegas in Las Vegas, Nevada. The session moderators are Michael R. Jaff, DO, and Krishna Rocha-Singh, MD.

According to VIVA, the prospective multicenter 80-patient NEAT study aims to characterize the efficacy and safety of creating endovascular arteriovenous fistula (endoAVF) using the minimally invasive everlinQ system (TVA Medical, Inc.). The everlinQ uses radiofrequency energy to create an anastomosis between different vessels than the traditional fistula and without open surgery.

The following are the preliminary findings from nine study sites in Canada, Australia, and New Zealand of these patients with stage 5 chronic kidney disease who needed a fistula.

The mean age was 60.1 years, 68% were men, 61% had diabetes, and 65% had a body mass index > 25 kg/m2. Fifty percent of patients were predialysis and 49% were using a central venous catheter before the procedure. An endoAVF was successfully created in 79/80 patients (99% procedural success). At 4 weeks, the rate of thrombosis was 3.75%.

Additionally, the NEAT data showed that an endoAVF may be physiologically suitable for dialysis based on the observed increase in brachial artery flow from a mean of 80 mL/min at baseline to a mean of 876 mL/min (P < .0001) and the statistically significant increase in vein (cephalic, brachial, median cubital) diameters beyond 4 mm (all P < .0001) at 1 month.

Dr. Lok concluded that the everlinQ system is an innovative, minimally invasive, catheter-based approach that can create an endovascular autogenous fistula safely, with high procedural success and an early low thrombosis rate. Long-term follow-up will reveal the functional patency and clinical utility of the endoAVF, noted Dr. Lok in the VIVA summary.

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November 3, 2015

ROADSTER 2 Postapproval Registry Begins for Silk Road Medical's Enroute NPS

November 3, 2015

ROADSTER 2 Postapproval Registry Begins for Silk Road Medical's Enroute NPS