Another Domestic Peripheral Embolization Coil Gains Market Approval

Sep 25, 2024 09:29 CST Updated 09:29

APT Medical

Cardiac Electrophysiology and Interventional Medical Device R&D Manufacturer

APT Medical

Minimally Invasive Cardiovascular and Cerebrovascular Interventional Device R&D, Manufacturer, and Distributor

Source: Heart Future; Editor: Seven Kite

Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.

Heart Future

Recently,APT Medical Inc.(hereinafter referred to as "APT Medical")Wholly-owned subsidiaryAPT Medical Inc.(hereinafter referred to as "APT Medical")Embolization CoilsObtainThird-Class Medical Device Registration Certificate，This product is used for the embolization of peripheral aneurysms, arteriovenous malformations, and arteriovenous fistulas.. The acquisition of this registration certificate has enriched the company's product portfolio and expanded itsPeripheral FieldProduct Layout.

# Product Introduction

Registration Certificate Number：CN Medical Device Registration No. 20243131782

Name of Registrant：APT Medical Inc.

Product Name：Embolic Coils

Management Category：Class III

Structure and Composition/Main Components：

The product is manufactured byCoils, Push Rods, and IntroducersComposition. The coil consists of a platinum-tungsten alloy spring and PET fibers, while the introducer consists of a hub and a tube body.The coil is preloaded in the introducer, and there is no connection between the coil and the push rod, no detachment is required.. The product is sterilized with ethylene oxide and for single use only. Shelf life is three years.

Scope of Application/Intended Use：

This product is used forEmbolization of Peripheral Arterial Aneurysms, Arteriovenous Malformations, and Arteriovenous Fistulas。

# Coil Embolization Market

Aneurysm is caused by lesions or injuries in the arterial wall, leading to localized or diffuse dilation or bulging of the arterial wall, mainly manifested as an expansive, pulsatile mass.Can occur in any part of the arterial system, most commonly in the limb arteries, followed by the abdominal aorta and carotid arteries.。

It is not a tumor in essence, but it looks like a "balloon-like" bulge growing on the artery, hence the name "aneurysm." Generally speaking, it is a localized, ball-like protrusion formed at a "weak point" on the arterial vessel wall due to the impact of blood flow, resembling a balloon blown up on the vessel wall that could rupture at any time.If left untreated, it can eventually lead to tumor rupture., clinically manifested as sudden onset of severe tearing pain that can radiate to the surrounding area, due to a large amount of bleeding,PatientPatients can rapidly develop cardiac tamponade and hemorrhagic shock, leading to death eventually, which is extremely dangerous.。

It is worth noting that true aneurysms of peripheral vesselsMay be accompanied by thrombosis, and some may lead to distal arterial embolism, resulting in ischemic necrosis of the soft tissue layer in the blood supply area.，At this point, regardless of the size of the aneurysm, intervention is necessary.。

The coil is a platinum metal wire, soft in texture.During embolization surgery, a microcatheter is inserted into the aneurysm cavity, and then a pusher is used to deliver the coil through the microcatheter into the aneurysm cavity.When the coil is stable within the aneurysm cavity, disconnect the connection between the pusher and the coil, withdraw the pusher from the microcatheter, and then prepare for the insertion of the next coil.

Principle of Coil Embolization

When blood flows into an aneurysm, many small vortices form at the edges of the aneurysm wall, similar to a river channel, and these vortices slow down the blood flow.Coiling an aneurysm actually means artificially increasing the slowing of blood flow, making the blood flow extremely slow., it basically stagnated in a short period of time and turned into a thrombus,The pressure within the aneurysm will significantly decrease, making the likelihood of rupture very small.。

With the popularity of interventional surgery,Currently, the annual global implantation volume of coils exceeds one million, with a global market size for this single product exceeding 10 billion yuan.。There are 47 imported coil products approved in China.，From Boston Scientific, Stryker, Cook, and MicroPort, respectively;There are 43 approved coil products made in China., respectively from Shanghai Xiaoyu Medical Technology Co., Ltd., APT Medical Inc., Zhejiang Guichuang Tongqiao Medical Technology Co., Ltd., Suzhou Zhongtian Medical Technology Co., Ltd., etc.

Part of the approved importsCoil Products

Part of the approved domestically produced coil products

As a high-value consumable,Before the centralized procurement, whether it is imported products or domestic brands,The prices of coils are relatively high.。But from the spring coil landing procurement in 2021, it now almost covers the entire Chinese market.The unit price has also dropped from 12,000 yuan to 3,277 yuan.On March 21-22, 2024, Sichuan Province and Shanghai successively announced the "Notice on Carrying Out the Filling Work of Historical Procurement Data and Procurement Demand Volume for Medical Consumables of the Spring Coil Category in the Beijing-Tianjin-Hebei '3+N' Alliance."New Round of Large-Scale Coil Procurement Begins in China。

Coil Spring Status Before 2024

# Similar (Peripheral) Competitive Products Introduction

FuseSuper® Peripheral Ciliated Embolization Coils - Little Fish Medical

October 2023,Shanghai Rongmai Medical Technology Co., Ltd.Wholly-owned subsidiary ——Shanghai Xiaoyu Medical Technology Co., Ltd.Self-developedFuseSuper® Peripheral Ciliated Embolization CoilsApproved by NMPA for marketing. FuseSuper® is the first peripheral product launched by Xiaoyu Medical.The First in ChinaNMPA-Approved Chinese-Manufactured Peripheral Free Ciliary Embolization Coil。

The product design adopts platinum-tungsten alloy and dense fiber hair, featuring excellent imaging performance, MRI compatibility, and biocompatibility, with two system sizes available: 0.018" and 0.035". Unique structural design.Reduce push resistance, prevent vascular injury, and make surgery safer.; At the same time, it possesses a unique technologyFree-floating Coil Loading and Delivery Device, which can enhance the comfort and stability of grip, and increase the degree of alignment and connection between the coil and the catheter, therebyImprove the stability and controllability of coil delivery and operation。

ZYLOX® Phoenix Peripheral Detachable Fiber-Coated Coil Embolization System——GuChuang TongQiao

December 2023,Guichuang Tongqiao(2190.HK) Announces that its subsidiary, Guicreation Medical, has independently developedZYLOX® Phoenix Peripheral Detachable Fiber-Coated Coil Embolization SystemApproved by NMPA for marketing. This is a product launched by Guiju Medical.The First ProductProducts for Peripheral Vascular Embolization Intervention。

ZYLOX® Phoenix was developed for minimally invasive interventional treatment of peripheral arterial embolism, building on the existing coil technology.Optimized and upgraded the interlocking arm release structure, enhanced the coil's ability to navigate bends, and reduced the risk of premature release.. At the same time, this product has been specially enhanced with polypropylene anti-unwinding threads, furtherSolved the pain point of premature coil unwinding.Compared with similar products currently on the market, ZYLOX® Phoenix coils offer a wider range of length and diameter specifications, providing more options to meet the needs of vascular embolization procedures.

Zhongtian Peripheral Embolization Coil System® —— Zhongtian Medical

April 2024,Suzhou Zhongtian Medical Device Technology Co., Ltd.TheZhongtian Huntu绫® Peripheral Embolization Coil SystemApproved by NMPA for marketing. Zhongtian Huntianling® Peripheral Embolization Coils are suitable forOcclusion of Peripheral Arteriovenous and Arteriovenous Fistulas. It is available on the marketThe First "Fully Controllable"Mechanical Detachment Peripheral Coils。

This product adopts a brand newSelf-expanding Clamp Lock Ball Head Mechanical Detachment Innovative DesignPlan, one-touch unlock rollback, instant safety release, safe, controllable, and easy to operate; the ball head maintains annular flexibility, the system has strong bending ability, and maintains good system control; not only can itPrevent insufficient release or accidental detachment of the coil, which enhances the controllability and safety of the operation. Moreover, if the coil packing is unsatisfactory or the size is inappropriate, the coil can be retrieved, removed, or readjusted and redeployed, making the operation more flexible.Surface Modification Treatment, further improving the biocompatibility and embolic efficacy of the coil.

Fibered Embolic Coils —— Heartpulse Medical

September 2024,Shanghai MicroPort CardioFlow Medtech CorporationTheSubsidiary——Shanghai Hongmai Medical Technology Co., Ltd.Developed byFibered Embolic CoilsApproved by NMPA for marketing. This product is suitable forPeripheral Vascular Aneurysms, Arteriovenous Malformations, and Arteriovenous FistulasWaiting for packing treatment.

The product's fiber bristles adopt a "twisting" process, making delivery smoother, and the high-density fiber bristles accelerate thrombus formation.Effectively Increase Embolization Density and Reduce Recanalization Risk; At the same time, a more reasonable fiber distribution design reduces the risk of jams during the push process, improving the comfort and stability of the push process.The coil portion consists of a platinum-tungsten alloy coil body and dense fiber fleece, offering excellent visibility, MRI compatibility, and biocompatibility; it is available in various diameters and lengths.It is the domestic free-floating coil with the most configurations., which can meet the clinical needs of various coil embolization procedure scenarios.

EMBOLD™ Fibered Peripheral Mechanical Detachable Coil with Fibers——Boston Scientific

September 2024,Boston ScientificUnder its umbrellaPeripheral Mechanical Detachable Fibered Coil EMBOLD FiberedApproved by NMPA. EMBOLD FiberedFor various embolization procedures, which received U.S. FDA approval as early as 2022, has already been launched in the United States, Canada, and Japan. This move into the Chinese market also marks Boston Scientific asThe only enterprise in China that covers fully controllable, semi-controllable, and free coils in the peripheral embolization field., providing more diverse treatment options for patients in China.

This coil can still be withdrawn after exiting the catheter, allowing for repeated adjustments to achieve the desired embolization effect.Reduce the Probability of Premature Detachment, while improving the safety of the surgery,Enhance Embolization Efficiency。No additional解脱器 required, simple实现 of full control, while reducing surgical steps and costs..Accurately identify coil deployment through auditory and tactile feedback. The unique nitinol delivery system provides robust anti-kinking performance, preventing buckling, twisting, and premature detachment during advancement. Enables faster and more precise operation, easily navigating distal and tortuous anatomical structures.

# Global Leading Cardiovascular Device Company

Medtronic｜J&J MedTech|Boston ScientificBoston Scientific|

Edwards Lifesciences | Abbott Abbott｜

# Chinese Cardiovascular Device Companies Listed in China

# Innovative Devices Approved in China in 2023

China Cardiovascular Innovation Device List [2023 Review]

#2023 Medical Devices Entering China's Innovation Pathway

XinQing Medical (NyokAssist Interventional Ventricular Assist System)

Beixins Life (Cardiac Pulse Field Ablation)

Hanling Medical (Transcatheter Aortic Valve)

# Other Unlisted/Start-up Cardiovascular Companies