Our Solution To Support Fistula Maturation

EchoMark & EchoSure

The patented EchoMark & EchoSure system is designed to enable any member of the care team to collect arteriovenous fistula volumetric flow rate, diameter and depth information at the dialysis clinic to assist with fistula maturation assessment.

 

Ultrasound for Any Member of the Care Team

EchoMark’s unique geometry enables EchoSure to collect and view quantitative flow information and vessel morphology without the need for precise probe positioning, orientation or parameter tuning.

Echomark Icon

Echomark

Vivid images.
Perfect orientation.

EchoMark is a highly echogenic, bioresorbable polymeric implant, manufactured using a patented technique and used for marking soft tissue sites in surgical patients.

Breakthrough manufacturing, brilliant images. To achieve vivid ultrasound images, we developed and patented a proprietary manufacturing technique to deliver a highly echogenic signal for a fully bioresorbable marker.

Before imageAfter image

B-mode ultrasound image

Fully bioresorbable

EchoMark uses a proven bioresorbable polymer with a long history of use in sutures and medical devices that dissolves within 18-24 months.

 

 

Unique Geometric Signature.

EchoMark’s innovative design yields a unique 2D cross-section and geometric signature for each angle from which it is viewed.

Echomark signature outline

Echosure Icon

Echosure

Ultrasound for any member of the care team.

EchoSure is designed to enable collection of arteriovenous fistula volumetric flow rate, diameter and depth information at the dialysis clinic to assist with maturation assessment.

Mobile medical ultrasound cart with a mounted touchscreen display, articulating arm, flat work surface, wire basket, and probe holder on a wheeled base.

Quantitative data provided by EchoSure may enable earlier clinical decisions by the care team.

Diagram of a vascular ultrasound assessment showing four measurement zones labeled Upper, Mid, Lower, and Echomark. Each zone lists diameter and depth values. Upper: Diameter 6.3 mm, Depth 4.1 mm. Mid: Diameter 6.0 mm, Depth 3.8 mm. Lower: Diameter 6.2 mm, Depth 3.5 mm. Echomark: Diameter 6.1 mm, Depth 3.9 mm. At the bottom, a circle displays ‘Venous Flow Rate 623 mL/min.’

Touchscreen medical imaging device

When operated by dialysis techs and nurses without ultrasound training, EchoSure demonstrated equivalent or better accuracy with less variability compared to standard duplex ultrasound operated by trained RVTs in a prospective, head-to-head benchtop study.2

EchoMark AVAccess Graph

 

Sonavex EchoMark AV Access Table

In a prospective multi-center trial, EchoMark & EchoSure demonstrated utility in assessing AV fistula maturation status when used by healthcare professionals without ultrasound training.3 The study confirmed that for fistulas that ultimately matured, the technology recognized radiographic maturation within an average of less than 4 weeks. Furthermore, clinical maturation was achieved earlier than reported in the literature. In this study, EchoSure scans took place at 2 weeks post-op, and monthly thereafter. In the ongoing RCT, fistulas will be evaluated biweekly.

 

Bar chart titled Time to Radiographic Maturation showing EchoMark & EchoSure study results. Mean time to radiographic maturation is 29 days. Median time is 18 days. A footnote states radiographic maturation is achieved once the fistula has achieved >500 mL/min in volume flow, >5mm in diameter and

 

Bar chart titled Time to Clinical Maturation comparing EchoMark & EchoSure study results to published literature. Study mean is 80 days. Study median is 66 days. Literature range spans 105 to 215 days. Notes explain that clinical maturation is achieved once the fistula has been used for 75% dialysis sessions with 2-needle cannulation over a 4-week period. Mean time to cannulation clearance was 61 days.

ECHOMARK & ECHOSURE

Better together

EchoMark & EchoSure were designed together to create a seamless and unique product experience.

REFERENCES:

  1. US Patent No. 11,382,714; US Patent No. 11,490,987; US Patent No. 11,858,181
  2. Calotta NA, et al. Automated 3D ultrasound enables novice users to measure arteriovenous fistula maturation parameters with comparable accuracy to conventional duplex by trained sonographers: Results of a benchtop study. Journal of Vascular Access. Mar 2022
  3. Lauvao L, Burgess J, O’Brien-Coon D, Rogers T, Yevzlin A, Beaver J. Bedside 3D ultrasound fistula maturation assessment by non-expert sonographers provides equivalent accuracy to formal duplex sonography: a prospective clinical trial. J Vasc Access. 2024;25(6):1–11. doi:10.1177/11297298241287609
  4. Thamer M et al. Medicare Costs Associated With Arteriovenous Fistulas Among US Hemodialysis Patients. Am J Kidney Dis. 2018 Jul;72(1):10-18
  5. Huber TS, Berceli SA, Scali ST, Neal D, Anderson EM, Allon M, Cheung AK, Dember LM, Himmelfarb J, Roy-Chaudhury P, Vazquez MA, Alpers CE, Robbin ML, Imrey PB, Beck GJ, Farber AM, Kaufman JS, Kraiss LW, Vongpatanasin W, Kusek JW, Feldman HI. Arteriovenous Fistula Maturation, Functional Patency, and Intervention Rates. JAMA Surg. 2021 Dec 1;156(12):1111-1118.
  6. Lok CE, et al. National Kidney Foundation. KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update. Am J Kidney Dis. 2020.
  7. Thamer M et al. Medicare Costs Associated With Arteriovenous Fistulas Among US Hemodialysis Patients. Am J Kidney Dis. 2018 Jul;72(1):10-18
  8. Shenoy S, et al. Clinical Trial End Points for Hemodialysis Vascular Access. CJASN. 2018 13(3):490-494.
  9. USRDS (United States Renal Data System) 2021 Annual Report.
  10. Woodside et al. Arteriovenous Fistula Maturation in Prevalent Hemodialysis Patients in the United States: A National Study. Am J Kidney Dis. 2018 Jun;71(6):793-801