Concept Medical Announces FDA IDE Approval for MagicTouch AVF Drug-Coated Balloon to Treat Arteriovenous Fistula Stenosis

Apr 13, 2024 07:30 CST Updated 07:30

Concept Medical

Medical Device Developer

During the process of continuous hemodialysis, the creation and maintenance of arteriovenous fistulas (AVF) are crucial to treatment. AVFs provide a reliable vascular access with few complications, allow repeated punctures, ensure stable blood flow, and have a long service life. They are widely recognized both in China and internationally as the preferred choice for patients undergoing maintenance hemodialysis. However, when AVF stenosis occurs, it can lead to poor blood flow, affecting the effectiveness of hemodialysis and potentially causing fistula occlusion, resulting in the loss of vascular access function.

Percutaneous transluminal angioplasty is a commonly used method for treating AVF stenosis currently. However, when using conventional balloon angioplasty, the restenosis rate is high, and the medium- and long-term patency rate is far from satisfactory. MagicTouch AVF (Sirolimus Drug-Coated Balloon) by Concept Medical is a new type of drug-coated balloon that can rapidly and uniformly deliver anti-proliferative drugs and quickly penetrate the vascular wall, exerting an inhibitory effect on the proliferation and migration of smooth muscle cells, thereby impeding the restenosis process.

April 2, 2024 – Concept Medical announced that it has received FDA Investigational Device Exemption (IDE) approval to initiate a clinical study of MagicTouch AVF for the treatment of stenotic AVF lesions, collecting safety and efficacy data to support a future FDA premarket approval application.

IMPRESSION Study

This is a prospective, multicenter, double-blind, randomized controlled clinical trial recruiting 170 patients, aimed at evaluating the efficacy of sirolimus-coated balloon (SCB) versus plain balloon angioplasty (PBA) in improving arteriovenous fistula (AVF) patency after percutaneous transluminal angioplasty (PTA). Patients will be randomly assigned in a 1:1 ratio to either the SCB or PBA treatment group, stratified by AVF location (above and below the elbow), with a follow-up period of up to one year. Inclusion criteria include: 1) adult patients aged 21-85 requiring PTA for AVF dysfunction; 2) AVFs that have been in use for at least one month prior to PTA; 3) successful PTA defined as residual stenosis less than 30% post digital subtraction angiography and restored AVF clinical function. Exclusion criteria include: 1) presence of thrombosis or partial thrombosis during PTA; 2) symptomatic or angiographically significant central vein stenosis with residual stenosis greater than 30% post angioplasty; 3) presence of stents within the AVF circuit, among others. The primary endpoint is access primary patency at six months. Secondary endpoints include target lesion primary patency. The study commenced on January 11, 2021, with recruitment and follow-up expected to conclude by May 2024.

IMPRESSION Flowchart

Schedule of Recruitment, Intervention, and Evaluation for the IMPRESSION Study

Inclusion and Exclusion Criteria of the IMPRESSION Study

MATILDA Trial

MATILDA: A Single-Arm Prospective Study of 33 Asian Patients with End-Stage Renal Failure (18 males, mean age 64.7 ± 11.6 years, 64% with diabetic nephropathy) to Investigate the Use of Sirolimus-Coated Balloons in AVF Stenosis, with a 12-Month Follow-Up

Kaplan-Meier Estimation of Secondary Patency, TLPP, and Primary Access Patency in 33 Patients with End-Stage Renal Failure and AVF

Application of Sirolimus-Coated Balloons in Arteriovenous Grafts (AVG)

A Single-Center Prospective Pilot Study on 20 Patients with Upper Limb AVG Thrombosis (Age: 67±10 Years; Male: 35%; Average Dialysis Duration: 31 Months): After Successful Pharmacomechanical Thrombectomy and Adequate Treatment of the Graft-Venous Anastomosis, Followed by Sirolimus-Coated Balloon Angioplasty at the Graft-Venous Anastomosis, All Adverse Events During the 6-Month Follow-Up Were Recorded. Results Showed Primary Patency Rates at 3 and 6 Months Were 76% and 65%, Respectively, Assisted Patency Rates at 3 and 6 Months Were 82% and 65%, Respectively. Secondary Circuit Patency Rates at 3 and 6 Months Were 88% and 76%, Respectively. Kaplan-Meier Analysis Estimated Mean Primary, Assisted, and Secondary Patency Durations to Be 285 Days (95% CI: 194-376 Days), 319 Days (95% CI: 221-416 Days), and 409 Days (95% CI: 333-485 Days), Respectively. No Adverse Events Directly Related to the Use of Sirolimus-Coated Balloons Were Observed.

Inclusion and Exclusion Criteria for Researchers

3-Month and 6-Month Study Follow-Up Results

Kaplan-Meier Survival Curve of the Pathway

MagicTouch AVF Drug-Coated Balloon Introduction

MagicTouch AVF is an innovative drug-coated balloon developed by Concept Medical Inc. It features a drug-release technology platform capable of releasing sub-micron particles of sirolimus, encapsulating these sub-micron particles within a biocompatible drug carrier to act as a long-term reservoir for sirolimus release upon reaching the vessel wall. Specifically designed for PTA, this balloon can be used to treat dysfunctional AVFs or stenotic lesions in AVGs with diameters of 4-12 mm and lengths not exceeding 100 mm after appropriate vascular preparation.

Concept Medical Inc. Introduction

Concept Medical is headquartered in Tampa, Florida, with a global presence. It focuses on developing innovative drug delivery technologies for the treatment of vascular and non-vascular diseases, utilizing unique technology and a proprietary portfolio, as well as exclusive coating techniques to deliver agents to the luminal surface of blood vessels.

Reviewed and Edited by: Dr. Chen Xi, Associate Chief Physician, Wuhan First Hospital

Editor: Vascular Information Oliver

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