Artio’s Amplifi System Treatment Before AVF Creation Studied in FIH Procedures
October 6, 2021—Surendra Shenoy, MD, presented findings from a first-in-human (FIH) evaluation of the Amplifi vein dilation system (Artio Medical, Inc.), which is a small, wearable blood pump device that dilates arm veins before arteriovenous fistula (AVF) creation. Amplifi is designed to improve AVF eligibility, reduce maturation failure, reduce time to maturation, and prolong primary and secondary patency.
The prospective, nonrandomized, single-arm, open-label, FIH clinical study in five patients with end-stage renal disease was conducted at Sanatorio Italiano in Asunción, Paraguay, and commenced in Q4 2020.
Dr. Shenoy presented the study’s findings during a late-breaking clinical trials session at the VIVA 2021, the annual Vascular InterVentional Advances meeting held October 4-7 in Las Vegas, Nevada.
In the VIVA Foundation’s press release, Dr. Shenoy explained the implantation of the Amplifi system. The inflow catheter is tunneled, inserted percutaneously into an internal jugular vein, and advanced under fluoroscopy to the right atrium. The outflow catheter is inserted into the forearm cephalic vein after surgical exposure. The catheters and controller are connected to the blood pump, and treatment is initiated.
According to the VIVA announcement, patients remained in hospital through-out the treatment period (mean, 8.6 days). Amplifi system blood flow was measured continuously, and contrast venography was performed periodically to measure vein diameter. Pump speed was increased during treatment to maintain wall shear stress of approximately 4 Pa in the treated veins.
After treatment, an AVF was created with a treated vein, and an ultrasound examination was performed 1 day, 2 weeks, and 6 weeks after AVF creation. Two radiocephalic and three brachiocephalic AVFs were created. In two patients, a dilated median ante-cubital vein was incorporated into the brachiocephalic AVF.
Dr. Shenoy reported that Amplifi system treatment resulted in 105%, 110%, and 85% increases in the diameter of the forearm cephalic, upper arm cephalic, and upper arm basilic veins, respectively.
The study found that AVFs created with Amplifi-treated dilated veins matured quickly, with outflow vein diameters and flow rates increasing to 7.0 mm and 1,100 mL/min, respectively, during the 6-week maturation period.
Additionally, there were no device- or procedure-related serious adverse events. The Amplifi vein dilation system uniformly dilated the outflow veins, increasing patient eligibility for AVF and resulting in early maturation. There were no adverse events, stated the VIVA announcement.
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