Biotimes Medical's Matrix Super PTX® — China's First Peripheral Constrained Drug-Coated Balloon Catheter Receives NMPA Approval

Aug 12, 2024 10:05 CST Updated 10:05

Barty Medical

Vascular Interventional and Implantable Device R&D Manufacturer

Source of the article: Heart Future; Editor: Jessi

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Heart Future

Recently,Zhejiang Barty Medical Technology Co., Ltd.Company(hereinafter referred to as "Barty MedicalDeveloped byPeripheral Constrained Drug-Coated Balloon Dilatation Catheter Matrix SuperPTX^®ObtainNational Medical Products Administration (NMPA)Approved for marketing,Registration Certificate No.: Z20243031382.

Matrix Super PTX® is produced in ChinaThe First ProductPeripheral Constrained Drug-Coated Balloon，For the first time, it achieves the perfect integration of lumen preparation and treatment functions in peripheral arterial endovascular therapy.。The unique design of Matrix Super PTX®,Achieving the clinical effects of two products with a single product, completing lumen preparation and lumen treatment in one stop, and effectively reducing the implantation of rescue stents,Truly achieve the clinical effect of 1+1-1>2。

Matrix Super PTX®marks the launch ofChina in High-Performance Vascular InterventionAn Important Step Forward in the Field of Medical Devices, which not only breaks the monopoly of international brands but also provides doctors and patients with more choices and better treatment experiences.

▲Matrix Super PTX® Peripheral Constrained Drug-Coated Balloon Dilatation Catheter (From Official Website)

In recent years, the clinical benefits and treatment concept of "intervention without implantation" have gained increasing recognition, leading to a growing usage of coronary drug-coated balloons.But there are still some pain points in the use of drug-coated balloons.For example: flow-limiting dissections may occur during vessel preparation, residual stenosis and elastic recoil may still exist after drug-coated balloon dilation, and sometimes rescue stenting is required. In terms of application scenarios, the approved indications for coronary drug-coated balloons are still limited to in-stent restenosis, small vessel disease, and bifurcation lesions.

To address the pain points and limitations of current coronary drug-coated balloons, Barty Medical has devoted itself to research and development, and collaborated with Academician Ge Junbo's team for improvement, jointly launchingThe World's FirstPaclitaxel-Coated Coronary Constrained Balloon Catheter with Plaque Modification and Blood Perfusion Functions, committed to treating coronary artery in-situ large vessel lesions.

April 19-21, 2024 in BeijingThe 9th Vascular Innovation ForumIn China,Multiple Experts in Endovascular Treatment of Peripheral VesselsShare and DiscussAbout Matrix Super PTX® Peripheral Constrained Drug-Coated BalloonLatest research results, design concepts andClinical Research Data。

Matrix Super PTX® Peripheral Constrained Drug-Coated BalloonLarge-scale clinical study led by Professor Wei Guo, Director of the Department of Vascular Surgery at the General Hospital of the People's Liberation Army，In collaboration with 24 clinical centers across China。

▲The 9th Vascular Innovation Forum (Beijing, China)

The study results show that, compared with the traditional treatment method of multiple bare balloon pre-dilations followed by drug-coated balloon dilation, Matrix Super PTX® Peripheral Constrained Drug-Coated Balloon inImmediate Instrument Success Rate、Surgical Success RateAndLong-term Follow-up Vascular Patency Rateetc.Achieved satisfactory non-inferiority results in all key clinical indicators.. This indicates that,Constrained drug-eluting balloons can effectively reduce the full pre-dilation steps and vascular preparation time, improving treatment efficiency.。

# Matrix Super PTX®

▲Matrix Super PTX® (Source: Official Website)

Matrix Super PTX®Perfect CombinationCompletedPeripheral Confinement BalloonAndDrug-Coated BalloonThe advantage,Through unique designAchieved one-stop lumen preparation and treatment process。Applicable for interventional treatment of renal arteries, iliac arteries, femoral-popliteal arteries, and infrapopliteal arteries.Full model coverage of 0.018" guidewire system, allowing the operator to handle infrapopliteal lesions without guidewire exchange, facilitating the operation.

The device is based on the Matrix Super® Peripheral Constrained Balloon Platform, adoptingUnique NiTi Alloy Wire Structure Design, with the increase of balloon inflation pressure,Balloon SurfaceWill form due to the limitation of the metal wireOrdered Convex-Concave Structure。ThisStructural Design of the Occipital and Decompression GrooveNot only can it achieveNon-invasive、Uniform expansion, and can alsoEffectively reduce the occurrence of flow-limiting dissections, thereby dilating the lesion site more safely.

In addition,Drug CoatingThrough Constraint BalloonMore closely adheres to the blood vessel wall, to achieveRapid Release of DrugsAndEffective Transfer, andMaintain a therapeutic concentration in the blood vessel wall for an extended period，Maintain Long-term Patency of the Vascular Lumen。

Product Features and Advantages:

Rich models: Matrix Super PTX® has204 Model Specifications, to meet the needs of different patients.
Smooth passage, effective expansion: This balloon is designed for uniform and controlled vascular dilation during the vessel preparation and pre-dilation stages.Effectively reduce vascular elastic recoil，Avoid Uncontrollable Tears and Flow-Limiting Dissections。
Reduce Remedial Stent Implantation: By optimizing the structure and materials of the balloon, Matrix Super PTX® can improve the long-term patency rate of drug-coated balloons.Reducing Dependence on Remedial Stents。
The only constrained balloon offering lengths of 150mm and 200mm: This unique length option provides doctors with moreOperational FlexibilityAndAdaptability。

The product's unique design and functionality enable clinicians toMore convenient and efficient in operation，Improved treatment outcomes，Reduced the incidence of complications, thereby having a positive impact on the entire peripheral artery disease treatment market.。

# LatestClinical Research

A prospective, multicenter, randomized, non-inferiority clinical study involving 141 cases. The patient inclusion criteria were a total lesion length ≤300mm and an occluded segment length ≤150mm. The purpose was to verify Barty Medical.Safety and Efficacy of Constrained Drug-Coated Balloons in the Treatment of Femoropopliteal Artery Stenosis and Occlusive Lesions。

The study adopted a balloon that is 2mm smaller than the reference diameter to pre-dilate all target lesions before randomization. The experimental group directly used a constrained drug-eluting balloon for treatment after pre-dilation, while the control group used a bare balloon with an equivalent reference diameter for full pre-dilation, followed by drug-coated balloon dilation. If residual stenosis of the lesion was >50% or flow-limiting dissection occurred after dilation, rescue stenting was required.The primary outcome of the study was defined as the primary patency rate at 12 months postoperatively., i.e., no clinically-driven target lesion revascularization and no restenosis diagnosed by Doppler ultrasound.

Experimental results show that the constrained drug-eluting balloon is used forThe Effect of Treating Femoral-Popliteal Artery Stenosis and Occlusive Lesions is Non-Inferior to Drug-Coated Balloons[74.17%（89/120）vs 65.29%（79/121）]；Its safety and the rate of remedial stent use (13.33% vs 14.05%) are similar to those of drug-coated balloons., ProofConstrained drug-eluting balloons can reduce the steps of adequate pre-dilation and vascular preparation time.。

AboutBarty Medical

Barty Medical (referred to as "Barty Medical") was established in August 2015, with its headquarters located in Hangzhou Biomedical Port, China. As a national high-tech enterprise, Barty MedicalFocus on the research, development, manufacturing, and sales of medical devices in the field of vascular intervention.. The main products of the company includeCoronary Drug-Coated Balloon、Peripheral Drug-Coated Balloon、Coronary PTCA Balloon、Peripheral PTA Balloon、Peripheral drug stents and配套的导管鞘、Contrast Catheter and Guiding Catheteretc.

Barty Medical has significant advantages in technology research and development, possessingMore than 50 patents, and obtainedMultiple Class III NMPA Registration CertificatesAndEU CE Certificate。In terms of products, Barty Medical's independently developedPeripheral Constrained Drug-Coated Balloon Dilatation Catheter Matrix Super PTX®AndUltra凰泰® II Generation Peripheral Double-Layer High-Pressure BalloonApproved for marketing this year, marking a further breakthrough and strategic layout of Barty Medical in the field of peripheral vascular interventional devices.

▲Barty Medical

Barty Medical not only performs outstandingly in the Chinese market but also actively expands into the international market. The companyHas obtained the special review process for innovative medical devices in three countries (also known as the "Green Channel"), and has undertaken several key R&D projects. Through continuous high-intensity R&D investment and independent innovation, Barty Medical has formed a product portfolio with international competitiveness.

Barty Medical inCompleted the C1 round of financing in December 2023.Financing amount nearly 100 million RMB. This round of financing was led by Huarui Investment, with existing shareholder Sanze Venture Capital continuing to increase their investment.The funds will be mainly used to advance the clinical registration and commercialization of its innovative product series of constrained balloons.. At present, the companyHas already initiated Series C2 financing, aiming to further expand scalable manufacturing capabilities to accommodate the rapid growth of future products and revenue.

In addition, Barty Medical also actively participates in industry exchanges and cooperation.On January 11, 2024, Fu Qiang, standing vice president and secretary general of the Hangzhou Venture Capital Association, led a team to visit Barty Medical and held in-depth discussions with multiple financial and investment institutions.On April 9, 2024, Barty Medical held the "Barty Gathering · Beyond the Ordinary" Strategic Distributor Conference, inviting nearly 60 strategic distributor partners from across China to jointly unveil the future development of the company.

Barty Medical, with its profound accumulation and innovative capabilities in the field of vascular intervention, is gradually becomingHigh-Performance Vascular Intervention Device Platform Enterprise, committed to providing safer and more effective treatment solutions for patients worldwide.

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