Lanx Medtech's Subsidiary Jilin Weal Medical Receives NMPA Approval for XinKai™ Coronary Nodule Balloon Dilatation Catheter

Product Name:Coronary Artery Balloon Dilatation Catheter

Registration Certificate Number:China Medical Device Registration No. 20253030308

Registration Classification:Class III

Scope of application:This product is suitable for balloon dilation of coronary artery stenosis in patients with coronary artery ischemia.。

This product is a rapid exchange balloon dilation catheter, composed of a tip, balloon, marker band, inner lumen tube, distal tube, transition tube, proximal tube, catheter reinforcement, and hub. The surface of the balloon catheter is coated with a hydrophilic coating.

HeartArmor™With a smaller Tip outer diameter and inner diameter, which not only enhances the ability to pass through lesions but also reduces the fish-mouth phenomenon; the balloon adoptsNylon 12+Pebax 7233 Double-Layer Material Design, effectively balancing the efficacy and safety of intraoperative treatment; the balloon is approved with a diameter of 2.0-4.0mm and a length of 8mm-20mm, with longer specifications available to meet various clinical trial scenarios.

The mastoid balloon is a special coronary vascular balloon., special balloons are based on ordinary balloon catheters, with cutting components attached to the outer surface of the balloon or protrusions manufactured on the working surface of the balloon. When the balloon is inflated and expanded, the pressure is focused and transmitted to the inner wall of the blood vessel through the cutting components or protrusions that extend beyond the surface of the balloon, achieving the purpose of cutting the intima of the blood vessel and expanding the narrowed blood vessel.

The ordinary balloon dilation catheter may cause uneven stress on the vascular wall during vessel expansion, leading to plaque compression and tearing, with risks of vascular dissection and other vascular injuries. It is difficult to address calcified or fibrotic lesions and prone to elastic recoil.The protruding part of the mastoid balloon gathers the squeezing force generated by the balloon expansion and transmits it to the contacted blood vessel wall.，Can achieve enhanced cutting force, directional uniform plaque incision, effective vessel expansion, reduced irregular vessel tearing, and minimized risk of dissection.。

The population of patients with coronary artery disease in China is continuously increasing. According to Sullivan's analysis, the number of patients will increase from 26.626 million in 2022.29.263 million in 2026, with a compound annual growth rate of 2.4% from 2022 to 2026, reaching 31.667 million by 2030.

Chronic Total Occlusion (CTO) of the coronary artery refers to a complete blockage of blood flow caused by atherosclerotic narrowing of the arterial lumen, with a disease course exceeding 3 months. It is considered the final stage of obstructive coronary artery disease.The prevalence of CTO in China is approximately 0.37%, and the number of patients is expected to increase from 5.325 million in 2022 to 6.333 million by 2030., with a compound annual growth rate (CAGR) of 2.0% from 2026 to 2030.Balloon dilation devices, as one of the primary treatment options, are seeing increasing demand.

For the mastoid balloon,Currently, there are very few products that have been approved for marketing in China, including6 domestically produced embolectomy balloons (4 coronary, 2 peripheral) and 1 imported coronary embolectomy balloon。

Mastoid balloon dilation catheters approved in China

Coronary Papillary BalloonAcrostak's GRIP™For example. This product is aHigh-Pressure Low-Compliance Anti-Slip Balloon with Solid Papillae, The use of a mastoid design can reduce the stiffness of the balloon, providing good trackability and crossability for navigating tortuous vessels and curved lesions. This product was approved for marketing in China in 2018 and is among the 28 types of medical consumables in the December 2023 "3+N" Alliance of Beijing-Tianjin-Hebei region.The only selected product in the concentrated bulk procurement category of mastoid balloons。

The working surface of the balloon has a row of papillae every 90°. The solid papillae ensure effective dilation of stenotic lesions even when the balloon is not fully inflated. The balloon is available in three lengths: 8mm, 12mm, and 16mm. The 8mm balloon has 3 papillae per row with 1mm spacing between papillae; the 12mm-16mm balloons have 4 papillae per row, with 1.7mm spacing for the 12mm balloon and 3mm spacing for the 16mm balloon.

GRIP™ High-Pressure Mastoid Balloon

Coronary Dilatation Balloons (C020205) and Coronary Drug-Coated Balloons (C020206) have been part of the alliance's centralized procurement for many years. Coronary Cutting/Scoring Balloons (C020207) and Coronary Spur/Papillary Balloons (C020208) were among the 28 types of medical consumables included in the December 2023 "3+N" Alliance centralized volume-based procurement in the Beijing-Tianjin-Hebei region.The price range for the selected products is between 1,198 and 4,978 yuan.The alliance regions include Anhui, Xinjiang Production and Construction Corps, Guangxi, Guizhou, Jiangxi, Liaoning, Qinghai, Sanming, Tibet, Xinjiang, and Yunnan, with a procurement cycle of 2 years.

December 2024,The Coronary Special Balloon Alliance procurement led by Henan has also entered the launch phase.。As the R&D and innovation capabilities of related enterprises improve, the brand influence of domestically produced special coronary balloons will further expand. Following the centralized procurement by the Beijing-Tianjin-Hebei 3+N Alliance, special coronary balloons are facing a broader range of price reductions due to centralized procurement.China-Produced Coronary Special Balloons to Enter Rapid Growth Phase, the process of domestic substitution is accelerating.

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