High Instantaneous Drug Payload – Next-Generation Peripheral DCB Arc'teryx™ Launches with Groundbreaking Design and Clinical Data
BrosMed Medical
High-end Medical Device Designer, Manufacturer, and Distributor
The 9th China Vascular Conference (CVC2024)InSeptember 12 to September 14, 2024InChengdu JuOkay, experts and scholars from all over the world gathered together, presenting a splendid feast of ideas and academic exchange. During the conference,BrosMed MedicalHeld【High-Dose Drug Coating】BrosMed Archangel™ Drug-Coated Peripheral Balloon Dilatation Catheter Launch Conference in China. Against the backdrop of how the next generation of DCB will redefine, the conference gathered numerous leading figures in the field of vascular surgery to deliver keynote reports and engage in academic exchanges. They discussed new technologies, introduced new products, and exchanged innovative ideas. Through layered design analysis of meticulously crafted products, as well as interpretations of surgical procedures, postoperative follow-ups, and clinical data, the conference provided attending experts with a unique BrosMed solution. By sharing experiences and exchanging knowledge, it contributed the BrosMed strength to the vascular surgery sector in China.
Special Invited Speech
At 13:10 on the afternoon of the 13th, the national launch conference officially began.CVC Congress Chairman and Principal Investigator of the Ancestor Bird Drug-Coated Balloon Clinical TrialProfessor Shu ChangProfessor Shu Chang delivered the opening remarks, in which he reviewed the history and status of drug-coated balloon applications. He stated that ensuring the drug is not lost during delivery, and achieves better release and absorption at the target vessel to attain favorable mid- to long-term outcomes at the target lesion, is a key focus for this product. He also expressed hope that participants would engage in open discussions and conduct more in-depth explorations during today’s Innovation Workshop.
Beijing Anzhen Hospital, Capital Medical UniversityProfessor Chen ZhongThe speech emphasized: The issue of drug-coated balloon shedding caused by blood flow flushing is inevitable! Throughout the development history of drug-coated balloons, the shedding problem has also drawn widespread attention. How to make drug-coated balloons resistant to blood flow flushing and maximize drug utilization has been a continuous focus. We are very pleased to see such an innovative product that turns this concept into reality. We highly anticipate that this domestically produced innovative drug-coated balloon can truly serve patients and bring clinical benefits. Just like its product name "Archaeopteryx," it is set to open new horizons in the medical field.
Zhongshan Hospital, Fudan UniversityProfessor Fu WeiguoSpeech: In today's flourishing DCB field, there is no consensus on which product is better. However, the emergence of Arc'teryx has revealed some notable features: zero powder loss during delivery, high loading at the target lesion, and long-lasting high drug retention. These characteristics are inseparable from the product’s outer protective sheath, water-soluble excipients, and microcrystalline needle structure. We also hope that such a product can benefit the people and allow more clinical patients to benefit.
Chinese PLA General HospitalProfessor Guo WeiSpeech: Innovation plays a very important role in clinical work, and only an innovative product can stand steadily in the market. The load marked on DCB is not the actual drug load; after being flushed by blood flow, the real drug load of DCB is much smaller than this. Archaeopteryx is a distinctive product with an exclusive protective sheath that ensures zero powder loss during delivery.2μg/mm²The load quantity is fully released in the target lesion, and the drug concentration in the target lesion is higher. It is a product that meets clinical needs and expectations, and it is a product that has opened up a new era.
Chairman of BrosMed Medical Co., Ltd.Mr. Li BinSpeech: Can China's future innovation in peripheral drug-coated balloon technology have the opportunity to lead a new direction for global product development? We look forward to starting from the pioneering efforts, supporting Chinese ingenuity, and benefiting patients worldwide—this is the goal of BrosMed Medical. As a local Chinese enterprise with multiple internationally leading technologies and innovative global products, this is also a commitment to promoting the development of China’s vascular intervention clinical practice and achieving a strong medical industry in China. We anticipate contributing even more BrosMed strength.
Listing Ceremony
Academic Session
Design Analysis of the New Generation Peripheral DCB Archaeopteryx™
Speaker:Mr. Luo Jingnan
Organization: Chief Scientist of BrosMed Medical
Review: Sun Yat-sen University People's HospitalProfessor Guangqi Chang、Liaoning Provincial People's HospitalProfessor Danming Wu, Jinan CenterHospitalQingyi MengProfessor
In the general use of drug-coated balloons, the most intuitively perceived problem is powder shedding, which may bring about a non-negligible risk of distal embolism. Due to the significant impact of powder shedding, the efficiency of drug delivery is also greatly reduced, with losses during the delivery process alone approaching 50%. From the initial design of the drug load capacity, manufacturers have already considered how much load should be designed to counteract the amount of powder loss and maximize the drug dose reaching the target lesion.Exclusive protective sleeve design by Arc'teryx,Extending from the handle all the way to the balloon tip, and closely fitting at the tail of the tip, protecting the entire balloon.Achieve zero powder shedding during the insertion and push processes,Minimize the risk of distal embolization and improve drug utilization.
Since the protective sleeve can ensure the drug delivery process is completely secure without falling off,Archaeopteryx Chooses the Lowest Drug Load: 2μg/mm². Archaeopteryx, which is in the梯队 of the lowest drug load globally, controls the diameter of drug particles to be under 20um through patented spray technology.Through innovative choices and technical breakthroughs in crystal processes, spray techniques, and excipients, a unique creation belonging to Arc'teryx was achieved.20um Needle-like Crystal Drug Coating Structure, Named CrystaCoat——MicroCrystal Needle,The entirely new drug structure has also brought about a completely new mode of administration.The microcrystalline needle is not attached to the surface of the endometrium but embedded into the endometrium., not only reducing the drug being washed away by blood, but also achieving long-acting multi-level drug delivery.
Interpretation of Archaeopteryx™ 12-Month Clinical Trial Data
Speaker:Professor Luo Mingyao
Unit: Fuwai Hospital, Chinese Academy of Medical Sciences
Comment: Henan Provincial People's HospitalProfessor Shuiting Zhai, Tianjin People's HospitalProfessor Li Li
Real-world study evidence of Archaeopteryx also demonstrates unique superiority. The clinical study of Archaeopteryx, led by Fuwai Hospital of the Chinese Academy of Medical Sciences and conducted across 16 centers with 199 enrolled participants, followed up for 12 months. Through angiography, patients with different lengths of stenotic occlusive lesions in the femoropopliteal arteries were strictly selected. According to the research protocol, real-world application data of Archaeopteryx was obtained: In terms of efficacy, the late lumen loss (LLL) of target lesions at 6 months post-procedure was 0.38mm, less than one-third of that from conventional balloon PTA. The primary patency rate at 12 months was 72.73%, and both freedom from CD-TVR and CD-TLR at 12 months were 95%. In terms of safety, the adverse event rate of Archaeopteryx at 12 months was only 8%. The restenosis rate was also less than half, at 30%. Analysis of primary and secondary efficacy endpoints confirmed the clear superiority of Archaeopteryx compared to conventional balloon PTA.
Archaeopteryx™ Clinical Classic Case Sharing
Speaker:Professor Li Xin
Unit: Second Xiangya Hospital, Central South University
Review: The First Affiliated Hospital of Chongqing Medical UniversityProfessor Zhao Yu, The First Affiliated Hospital of Zhengzhou UniversityProfessor Li Zhen
Professor Li Xin shared two case studies. In the case of a patient with diabetes and intermittent claudication, Professor Li Xin evaluated the deployment method, which was similar to that of a self-expanding stent. After positioning, the protective outer sheath was retracted, and subsequent operations were no different from existing DCBs. At the 6-month follow-up of the two cases, the distal lesion and outflow tract showed good imaging, and the affected vessels remained patent.
He concluded: The Archaeopteryx™ DCB has excellent passage ability, combining flexibility and support. It performs smoothly in crossing operations and follows the guidewire smoothly. It truly achieves zero drug particle loss during the loading and delivery processes, with no visible drug detachment during the procedure. There were no occurrences of slow flow or distal no-reflow during the surgery, significantly enhancing safety.
Immediate lumen gain and favorable mid-term follow-up data.
Commentary Expert
In Solnhofen, Germany, the stunning Archaeopteryx fossil has traversed hundreds of millions of years with its feathers still vividly intact, as Earth bid farewell to the dinosaur era and the age of birds redefined the world through their soaring flight.
BrosMed Medical's Archaeopteryx™ is also the world's first innovative product with a protective sleeve design. This design is believed to redefine the future of drug-coated balloons, much like the miraculous choice of feathers in the origin of life.
BrosMed Medical named it as such.
Embracing technology for life is the mission of Archaeopteryx, as well as BrosMed Medical. Located in the Greater Bay Area, BrosMed Medical has successfully contributed five meticulously crafted products to the domestic balloon team in the peripheral intervention field. These are the Baqili Non-Compliant Balloon, TICHE High-Pressure Balloon, Tyrannosaurus Rex Hemodialysis Access Balloon, Triceratops Scoring Balloon, and the launch of Archaeopteryx, which further completes the product line in the peripheral artery field. In sync with the times, moving forward with more companions, and jointly enriching the range of domestically produced balloon options, BrosMed Medical will continue to lead with innovation and forge ahead.
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