Epate Medical's Peripheral Detachable Coil Receives Class III Medical Device Approval in China

Registration Certificate Number：CN Med Dev Reg 20243132222

Name of Registrant：APT Medical Inc.

Product Name：Peripheral Detachable Coils

Management Category：Class III

Structure and Composition/Main Components：

The product consists of a coil, an introducer sheath, and a push rod.The coil consists of a platinum-tungsten alloy spring, PET fibers, PP connecting wires, and a platinum-iridium alloy detachment ring.The push rod is composed of a push rod head, winding wire, mandrel, marker, and hydrophilic coating.

Scope of Application/Intended Use：

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

Aneurysm is a localized or diffuse dilation or bulge of the arterial wall caused by lesions or injuries, 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 essentially a tumor, 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 by a "weak point" on the arterial wall under the impact of blood flow, similar to a balloon on the vessel wall that could burst at any time.Without treatment intervention, 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 hypovolemic shock, ultimately leading to death, 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.In embolization surgery, a microcatheter is inserted into the aneurysm cavity, and then a pusher is used to advance 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 artificially slows down blood flow, making it 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 implant volume of coils exceeds one million, with a single-product global market size surpassing 10 billion yuan.。More than 25 imported detachable coil products (intracranial, peripheral) have been approved in China.，From Boston Scientific, Stryker, MicroVention,Micro Therapeuticsetc.;More Than 23 Approved Detachable Coil Products (Intracranial, Peripheral) Made in China, respectively from MicroPort NeuroTech, Shenqi Medical, APT Medical, Guichuang Tongqiao, Jiaqi Biotech, Zhongtian Medical, etc.

Part of the approved imported detachableCoil Products

Part of the approved domestically produced detachable coil products

# Similar (Peripheral) Product Introduction

Qi Yi® Detachable Fiber-Coated Coil —— Shen Qi Medical

Qi Yi® Detachable Fibered Coil Embolization System was approved for marketing by the National Medical Products Administration (NMPA) in January 2022.The First Chinese-Made Product Dedicated to Peripheral VesselsDetachable Fiber-Coated Coil Embolization System。

Qi Yi®Used to occlude or reduce blood flow velocity in the peripheral vascular system during embolization procedures., which can be used for peripheral vascular system embolization surgeries such as hemorrhage control, aneurysms, adjuvant therapy, and vascular malformations. The product featuresFlexible and Detachable, Stable Basket Formation, Dense EmbolizationCharacteristics: Can be fully withdrawn before complete release, ensuring excellent controllability; processed with a patented shaping technology to ensure the product conforms to the lesion shape and forms a stable basket; patented structure design with fiber hairs achieves better embolic effects compared to bare metal coils, promotes thrombosis, and reduces the risk of aneurysm recanalization.

ZYLOX® Phoenix Peripheral Detachable Fiber-Coated Coil Embolization System——Guichuang Tongqiao

December 2023,Guichuang Tongqiao(2190.HK) announced that its subsidiary, Guicreation Medical, independently developedZYLOX® Phoenix Peripheral Detachable Fiber-Coated Coil Embolization SystemApproved by NMPA for marketing. This is launched by Guicreation Medical.The First ProductProducts for peripheral vascular embolization interventional procedures。

ZYLOX® Phoenix was developed for minimally invasive interventional treatment of peripheral arterial embolism, building upon the existing coil technology.Optimized and upgraded the interlock arm release structure, enhanced the coil's bending ability, and reduced the risk of premature release.. At the same time, this product specially adds polypropylene anti-unwinding wires, 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 Mix Tianling® Peripheral Embolization Coil System —— Zhongtian Medical