High Instantaneous Drug Payload – Next-Generation Peripheral DCB Arc'teryx™ Launches with Breakthrough Design
BrosMed Medical
High-end Medical Device Designer, Manufacturer, and Distributor
The 9th China Vascular Conference (CVC2024)InSeptember 12 to September 14, 2024InChengdu LiftingOkay, 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 Arch™ Drug-Coated Peripheral Balloon Dilatation Catheter Launch Conference in China. Against the backdrop of how the next generation DCB will redefine, the conference gathered numerous leading figures in the field of vascular surgery to deliver special reports and engage in academic exchanges. They discussed new technologies, talked about new products, and exchanged innovative ideas. Through layered design analysis of meticulously crafted products, interpretation 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 cause in China.
Special Invited Speech
At 13:10 on the afternoon of the 13th, the national launch conference officially began.CVC Conference 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 from the balloon, better released and absorbed in the target vessel, and achieves good mid- to long-term efficacy in treating the target lesion, are key focuses of this product. He also expressed his hope that participants would speak freely and engage in more in-depth discussions during today's Innovation Workshop.
Beijing Anzhen Hospital, Capital Medical UniversityProfessor Chen ZhongThe speech emphasized: The issue of drug-coated balloon (DCB) shedding caused by blood flow flushing is inevitable! Throughout the development history of DCBs, the shedding problem has also drawn widespread attention. How to make DCBs resistant to blood flow flushing and maximize drug utilization has been a continuous focus. We are very pleased to see such a DCB turning this concept into reality. We highly anticipate that this innovative, China-produced DCB 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 capacity 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 will benefit the people and allow more clinical patients to benefit.
Chinese People's Liberation Army General HospitalProfessor Guo WeiSpeech: Innovation plays a very important role in clinical work, and only an innovative product can establish a firm position in the market. The loading capacity marked on DCB is not the reloading capacity, which is much smaller after being flushed by blood flow. Archbird is a distinctive product with an exclusive protective sheath and zero powder shedding during the delivery process.2μg/mm²The load capacity 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 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 the global product development direction? We look forward to starting from Archimed, supporting China's original creations, and benefiting patients worldwide—this is the goal of BrosMed Medical. As a local Chinese enterprise with multiple internationally leading technologies and globally innovative products, this is also a commitment to promoting the development of China's vascular interventional clinical field and achieving a strong medical industry in China. We look forward to contributing more BrosMed strength.
Listing Ceremony
Academic Session
Design Analysis of the New Generation Peripheral DCB Archaeopteryx™
Speaker:Mr. Luo Jingnan
Affiliation: Chief Scientist of BrosMed Medical, Expert of the National Thousand Talents Plan
Comment: 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 embolization. Due to the significant impact of powder shedding, the efficiency of drug loading is also greatly reduced, with losses during the delivery process alone approaching 50%. From the design of the payload capacity, manufacturers have already considered how much payload should be designed to counteract the amount of powder shedding 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 tightly 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 well protect the drug delivery process from falling off completely,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 spraying technology.Through innovations and technological breakthroughs in crystal processes, spray techniques, and excipient selection, a unique achievement exclusive to Arc'teryx has been created.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., which not only reduces the drug being washed away by blood but also achieves 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
Review: 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 study protocol, real-world application data of Archaeopteryx was obtained: In terms of effectiveness, the late lumen loss (LLL) of the target lesion at 6 months post-procedure was 0.38mm, less than one-third of that for 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 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: Xiangya Second 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 self-expanding stents. 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 results, and the affected vessels remained patent.
He concluded: The Archaeopteryx™ DCB has excellent passage capability, 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 shedding 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 the Earth bid farewell to the age of dinosaurs and the era of birds redefined the world through their 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.
"Technology Embraces Life" is the mission of Archaeopteryx, as well as that of BrosMed Medical. Located in the Greater Bay Area, BrosMed Medical has successfully contributed five meticulously crafted products to China's peripheral intervention balloon lineup: the Baqili Non-Compliant Balloon, TICHE High-Pressure Balloon, Tyrannosaurus Rex Hemodialysis Access Balloon, Triceratops Scoring Balloon, and the launch of Archaeopteryx, which further enhances the product portfolio in the peripheral artery field. In sync with the times, and alongside more companions, BrosMed Medical will continue to enrich the range of balloon options produced in China, persistently driven by innovation.
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