Clinical Trial of Tri-Wedge PTA Scoring Balloon Dilatation Catheter -- MEDICA - World Forum for Medicine

12.11.2020

BrosMed Medical Co., Ltd.

Clinical Trial of Tri-Wedge PTA Scoring Balloon Dilatation Catheter

Tri-Wedge PTA Scoring Balloon Dilatation Catheter (hereinafter referred to as Tri-Wedge), manufactured by Brosmed Medical Co., Ltd., is an “over-the wire” catheter with a unique feature that three stainless steel wires (triangular cross-section) are evenly distributed on the outer surface of the balloon, which creates a focal stress pattern to dilate the stenotic lesion at lower pressure. The technology has been applied for international and Chinese patents. The product is indicated to dilate the stenosis in the iliac, femoral, iliofemoral arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. 

Tri-Wedge can achieve the same luminal gain with lower inflation pressure and minimal slippage because of three scoring stainless steels, also possesses soft tip, extraordinary crossability, and smaller profile size for passing through severely calcified stenotic lesions. The catheter is the unique product on the market targeted at arteriovenous fistula stenosis. It has been approved for listing in the EU and Singapore.

As shown in the PDF, the balloon is available in a wide range of sizes.

A clinical study led by Peking University First Hospital to evaluate the safety and efficacy of Tri-Wedge for Treatment of Dysfunctional AV Fistula (referred to as Tri-Wedge clinical trial) started on June 9th, 2020. Prof. Jin Qizhuang’s team which successfully performed the first case, applying the Tri-Wedge to treat arteriovenous fistula stenosis in hemodialysis patient. The successful implementation of the procedure also marks the official launch of multi-center Tri-Wedge clinical trial nationwide. Six nationally renowned clinical centers participate in the trial. The procedure will be conducted by experienced clinical experts, with their exquisite medical skills and well-designed equipment, the trial would complete as expectation with no doubt and introduce a groundbreaking product to the Chinese market.

Until November 5th,2020, Tri-Wedge clinical trial has successfully enrolled 47 subjects, completed follow-up in 12 cases, with no device-related adverse events or device defects, revealing good therapeutic effect.

A subject by Peking Tong Ren Hospital has a target vessel with a diameter of 5 mm and a length of 24 mm. The physicians chose Tri-Wedge size of 5.0 mm ×40 mm, and the balloon sufficiently dilated under an inflation pressure of 4 atm. To consolidate the effect, the catheter continued to be inflated to 12 atm. The residual stenosis was measured after the operation, showing a result of 5% under post-operation DSA, 10.53% under DUS, revealing great success of the procedure. This case adequately demonstrated that the Tri-Wedge can sufficiently dilate the stenotic lesion under a low inflation pressure.

This clinical study would provide sufficient evidence for the safety and efficacy of the Tri-Wedge in the treatment of autologous arteriovenous fistula stenosis, bringing good news to hemodialysis patients.

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