Recently, the "Peripheral Scoring Balloon Dilation Catheter," independently developed by Jingtu Medical Devices (Jiangsu) Co., Ltd., a subsidiary of Mednovo Group, obtained Class III medical device registration approval from the National Medical Products Administration (NMPA). The registration certificate number is: ¹úеע׼20263030469. With this, Mednovo Group has now accumulated a total of 49 approved products on the market.

Product Background£º

In recent years, the incidence of cardiovascular diseases has shown an increasing trend under the influence of an aging population, unhealthy lifestyles, and dietary habits. Interventional therapy has become a primary treatment method. Driven by the "intervention without implantation" philosophy, the specialty balloon sector has risen rapidly. These balloons not only address the limited dilation capacity of conventional balloon catheters for vascular stenotic lesions but have also gradually evolved from an adjunctive therapy to a primary treatment modality for multiple indications.

Product Principle£º

The peripheral Scoring balloon catheter works by inflating the balloon, which concentrates the dilation pressure onto its three longitudinal spines. This allows the spines to embed into the plaque, creating fissures in the plaque and achieving the goal of uniformly and stably dilating the stenosis.

Indications£ºIndicated for dilatation of stenoses in the peripheral vascular system, including stenoses in the iliac arteries, femoral arteries, iliofemoral arteries, popliteal arteries, infrapopliteal arteries, and renal arteries, as well as for the treatment of obstructive lesions in native or synthetic arteriovenous fistulae

Product Advantages£º

1. Pressure Focusing

Upon balloon inflation, the surfaces of the spines come into contact with the vessel, focusing the pressure onto the three spines. This exerts greater force on the vascular lesion, creating a scoring effect to achieve the purpose of dilating the stenosis.

The spines are oriented parallel to the push shaft (proximal catheter of the balloon). The orderly scoring created by this orientation follows the direction of blood flow, potentially reducing the occurrence of vascular dissections.

2. Plaque Scoring and Anti-Slippage

In vitro dilation experiments using a plaster model simulating human calcified lesions have confirmed that the Scoring balloon effectively scores calcified lesions.   

Stress-strain analysis demonstrates that the Scoring design transmits pressure more effectively, reducing the risk of balloon slippage.

3. Comprehensive Size Coverage

Balloon diameters available from 2.0mm to 7.0mm

Effective lengths available: 500mm, 900mm, and 1450mm.

Broader size range to treat more lesions.