Source of the article: HeartFuture; Editor: SophiaReprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.Recently,Nanjing YDB Medical Technology Co., Ltd.Independently DevelopedPaclitaxel-Coated Coronary Balloon Dilatation CatheterOfficially received the certification issued by the National Medical Products Administration (NMPA)Medical Device Registration Certificate (China Medical Device Registration Certificate 20243031552, andMedical insurance code approved, marking the official launch of this innovative product in the Chinese market, bringing good news to a large number of patients.Paclitaxel-Coated Coronary Balloon Dilatation CatheterSecond-Generation Non-Ionic Contrast AgentsAs a drug-loading matrix,Focus on Small Vessel Disease; using advanced drug coating technology,"Fine Grain Strengthening" Spray Process，Can effectively inhibit the hyperplasia of vascular intima while dilating blood vessels.，Reduce the Risk of Restenosis, providing a safer and more effective treatment option for patients with coronary heart disease.
Paclitaxel Coated Coronary Balloon Dilatation Catheter isCovering a layer of anti-proliferative drug—paclitaxel on a traditional balloon,YesBalloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty.This device enables paclitaxelRapidly penetrate the vascular wall to exert efficacy within the duration of a single balloon expansion., delivering anti-proliferative drugs to the affected area,Withdraw from the body after the drug has been fully released., achieving "intervention without implantation".
The product isRapid Exchange TypeBalloon Dilation Catheter(Semi-compliant). Mainly byCatheter hub, catheter, drug-eluting balloon, and marker bandComposition: The catheter is composed of a hypotube, proximal outer tube, distal outer tube, and inner tube. The hypotube material is a stainless steel tube with a PTFE coating. The material of the proximal outer tube/distal outer tube is nylon 12, and the distal outer tube is coated with a polyvinylpyrrolidone hydrophilic layer.
The balloon material is polyetheramide block copolymer, and the drug contained in the balloon surface coating is paclitaxel.，The dose is 3.0μg/mm², and the drug carrier matrix is ioversol.The material of the imaging ring is platinum-iridium alloy.Guidewire Adapter:0.014 inches（0.36mm) Indications: For vessels with a diameter ≥2.0mm and ≤2.75mmPrimary Coronary Small Vessel DiseaseTreatment.In situ lesions, safe and effective：A reasonable proportion of liquid preparation ensures effective absorption of the drug.Duration of Effective Drug Concentration in Target VesselsMore than 28 days,All indicators demonstrate non-inferiority compared to similar foreign products.Tiny branches, where there is obstruction, there must be flow.：Focus onSmall Vessel Disease(Vessel diameter ≥ 2.0mm and ≤ 2.75mm), CatheterCan smoothly pass through tortuous small blood vessels, deliver drugs to the target lesion, and during expansion, the drug can fully and evenly cover the lesion site and be quickly absorbed by the target vessel.Crystalline Coating, Rapid Absorption：Crystalline Form of Paclitaxel Drug Coating, Easier to Absorb. Adopting the "fine grain strengthening" spraying process, the drug "grain size" is smaller and easier to absorb. The drug coating is smooth and uniform, and not easy to peel off or produce debris.Hydrophilic and Lipophilic, Better Fusion: The drug-loaded matrix adopts the second-generation non-ionic contrast agent, which is safer. Hydrophilic and lipophilic efficient fusion,Promoted the release and absorption efficiency of paclitaxel, ensuring the drug dosage and therapeutic effect at the target vessel site.On July 7, 2024, the "Symposium on Management and Prevention of Cardiac Critical Conditions," jointly organized by the Cardiac and Great Vessels Branch of the Anhui Provincial General Practitioners Association and Bengbu Second People's Hospital, successfully concluded.At the conference site, YDB made a brilliant appearance with its coronary intervention overall solution products, includingYDB's Star New ProductPaclitaxel-coated coronary balloon dilation catheter, LeSifter left atrial appendage occlusion system, and disposable invasive pressure sensor.It is worth mentioning that, for the thromboembolic risks faced by patients with atrial fibrillation, YDB has introduced an innovativeLeSifter Left Atrial Appendage Occluder. The product is delivered through minimally invasive intervention,Precisely locate and occlude the left atrial appendage, effectively preventing thrombus formation and detachment, and significantly reducing the incidence of severe complications such as stroke.。Unique Positive and Negative Barb Structure, making the occluder more firmly and stably locked in the left atrial appendage. Meanwhile, the occluder extends from the proximal to the distal end.Gradient Hardness Design, balancing support and flexibility, making the distal end of the occluder's mesh stent smoother and more complete, fitting better with the left atrial appendage, reducing left atrial appendage injury, and lowering the patient's intraoperative risk.- On August 1, 2024, the company launchedDisposable Invasive Pressure Sensor.
The disposable pressure sensor consists of an infusion device, signal output cable, perfusion valve, sensor chip, three-way valve, transmission tubing, three-way connector, extension tube, etc. Its structure is shown in the figure. (Accessories: plug cap, color code).Adopting imported chips, Unique Bonding Process：Precision assembly ensures measurement accuracy, with excellent electromagnetic compatibility and high precision.Continuous working time can reach 168h, adaptable to the complex electromagnetic environment of the catheterization laboratory. Hemodynamic monitoring, continuous monitoring of radial artery pressure, central venous pressure, pulmonary artery pressure, atrial pressure and other blood pressure waveforms.Unique Flushing Valve Design：Microporous structure,Simple and easy to use, precise flow rate, integrated injection molding, high-strength stretching without breaking, continuous infusion flow controlled at 3ml/h.Closed Blood Collection System：Blood can be collected simultaneously while monitoring blood pressure, and a closed blood collection system canMinimize the Risk of Infection, reducing the harm and suffering to patients caused by multiple blood-drawing punctures.Fluid Path Management, Multiple Sensors Can Be Installed on the IV Pole Simultaneously：Use different color codes for fluid path management,Efficient operation cable connectors with ergonomic design, easy to plug and unplug, prevent misoperation. Strong compatibility,The cable connector can be used with mainstream monitors on the market, such as Mindray, Philips, GE, etc.。- In June 2024, the company launchedDisposable UseAdjustable Bend Guide Sheath Set，Is a catheter with a distal shape that can be adjusted according to the lesion.Different location paths, by the surgeonAchieve autonomous regulation in vitroThe adjustable bending sheath.
The disposable adjustable bend guiding sheath set consists ofAdjustable Bend Guide Sheath and DilatorComposition,The product allows for multi-angle and multi-plane free adjustment.Adapting to different physiological structures, meeting coaxial occlusion requirements；The addition of a metal marker ring and contrast agent at the distal end facilitates precise positioning.Different handle designs at the proximal end improve ease of use for doctors;Reduced the difficulty and complexity of the surgery, saving operation time..The segmented design enables the adjustable bent guiding sheath set to have excellent support performance, making it less likely to kink during delivery; reducing vascular injury.- May 2024，Launched by the companyBelow-the-Knee Balloon Dilatation Catheter, which is an over-the-wire (OTW) percutaneous transluminal angioplasty balloon catheter, suitable forEndovascular Dilatation Treatment for Stenosis or Occlusion Lesions of Arteriovenous Vessels Below the Knee。
The balloon catheter is an intravascular catheter, mainly composed of a catheter hub, a double-lumen tube, a balloon, an inner tube, a radiopaque marker, and a hydrophilic coating.Dual-lumen tube structure design,Improved catheter pushability, kink resistance, and guidewire trackability. When passing through curved vessels,Reduce "Fish Mouth" Phenomenon，Making the surgical process smoother and reducing patient suffering.ThroughOverMulti-wing Folding TechnologyProgressOne StepReduce Through Outer Diameter, and at the same time hasVery goodRebound, Retraction Ability. Catheter'sThe distal surface is coated with a hydrophilic coating.，Make the catheter have super-slip performance, reducing friction with blood vessels,With betterTransmissibility。- On April 19, 2024, the company held a strategic cooperation signing ceremony with CR Pharmaceutical in Nanjing.
YDB Medical has been committed to the research, development, and innovation in the field of pan-vascular interventional treatment.CR Pharmaceutical has extensive pharmaceutical resources and a strong market foundation.It has in ChinaLeading pharmaceutical distribution and retail platform with nationwide network coverage in China, providing professional and efficient logistics distribution, marketing promotion, and other innovative value-added services for upstream suppliers and downstream customers in the pharmaceutical industry.BusinessDistributed in 144 cities across China, with 460 subsidiaries, 204 logistics centers, and a total area of 1.25 million square meters,The number of customers exceeds 150,000., including 9,543 secondary and tertiary hospitals and nearly 70,000 grassroots medical institutions.# About YDB
Nanjing YDB Medical Technology Co., Ltd. was established in October 2013, with a registered capital of 100 million yuan. The company is located in Nanjing Gaochun Economic Development Zone and is focused onCardio-cerebral and Peripheral Pan-vascular Intervention and Stroke Prevention InterventionHigh-end medical device supplier.The company integrates research and development, production, and marketing, and has established a comprehensive ISO 13485 quality management system. It has successively been awarded the titles of "National High-tech Enterprise," "Outstanding Private Enterprise in Nanjing," "Nanjing Gazelle Enterprise," "Nanjing Recognized Enterprise Technology Center," "Nanjing Engineering and Technology Research Center," and "Specialized, Precise, Unique, and Innovative Small and Medium-sized Enterprise of Jiangsu Province."The company adheres to the concept of "intervention without implantation" and focuses on high-value consumables in the pan-vascular field.Currently, there are 5 Class II and 11 Class III products on sale, and 14 Class III products under development.The company owns more than 60 intellectual property rights and has applied for 1 provincial science and technology plan special project and 1 municipal science and technology plan special project.
As a leading medical device company introduced by the Gaochun District Government of Nanjing City, the company acquired a hundred acres of new land in the Gaochun Development Zone in 2018.Construction of a 100,000-square-meter R&D and production base for the "Pan-Vascular Medical Device Project", committed to the in-depth development in the fields of acute and chronic coronary heart disease, prevention of cardiogenic stroke, and treatment of ischemic stroke.
