Shanghai Shenqi Medical's QiRui® CRipper® Cutting Balloon System Receives NMPA Approval

Oct 08, 2024 09:05 CST Updated 09:05

Shenqi Medical

Cardiovascular Interventional Device Developer

Source of the article: HeartFuture; Editor: Sophia

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

Heart Future

Recently,Shanghai Shenqi Medical Technology Co., Ltd.TheQi Rui^®CRipper® Cutting Balloon SystemApproved for marketing by the National Medical Products Administration (NMPA)。Thus, in China currentlySeven models have been approved for marketingCutting balloon products, including three from Boston Scientific,Four domestically produced devices have been approved for marketing in China., respectively belong toLepu Medical (2 models), Baiyi Hui (1 model), and Shenqi Medical (1 model)。

In the interventional treatment of coronary heart disease, the use of balloon dilation catheters to achieve vascular expansion is a common therapeutic approach. However,Ordinary balloon dilation catheters may not achieve ideal therapeutic effects when used alone to address some special and complex lesions.。Cutting Balloon: A Special Balloon that Combines Micro-cutting Technology with Traditional Balloon, provides a new option for achieving good therapeutic effects.

QiRui® CRipper® isRapid Exchange Cutting Balloon Dilatation Catheter, with both excellent cutting performance and superior passability,Can be used alone for lesions that only require cutting., open lesions or in-situ small vessel disease, etc.; alsoCan be used in conjunction with drug-eluting stents, drug-coated balloons, bioresorbable scaffolds, and other products., as a pre-processing device, ensures that the drug-coated balloon or stent is fully apposed to the vessel wall, thereby achieving the goal of optimizing therapeutic outcomes.

# Product Information

Structure and Composition

Qirui^®CRipper^®Cutting Balloon System (hereinafter referred to as "Qirui")^®CRipper^®"）is a rapid exchange type cutting balloon dilation catheter;Mainly byBalloon, Blade, Outer Tube, Inner Tube, Hub, Radiopaque Marker, Tip, Stress Relief Tube, etc.With both excellent cutting performance and superior passability。

Surface Distribution3 or 4 rows of stainless steel blades, The distal outer surface of the balloon catheter is coated with a PVP hydrophilic coating, the balloon portion has two radiopaque markers, and the proximal luer connector can be connected to accessories.

Design Highlights

Cutting BalloonCombining Micro-cutting Technology with Traditional Balloons, and can handle special and complex lesions very well.

Better expansion effect:The surface is embedded with 3-4 rows of miniature stainless steel blades. Before reaching the lesion, the blades are tightly wrapped within the balloon material, ensuring no harm to normal blood vessels.When the balloon reaches the lesion and expands, the blade extends beyond the balloon surface, making a longitudinal incision along the vascular wall through the atherosclerotic plaque and vessel wall.By finely dissecting the lesion site,Relieve circumferential stress and reduce balloon expansion-induced damage to the vessel wall.，And effectively reduce the slippage during balloon inflation, achieving better expansion results.
Reduce Complications:Compared with traditional plain balloon angioplasty,The cutting balloon can cause the intima of the diseased vessel to be affected by balloon expansion.The injury is localized to the incision site.，Significantly reduce the incidence of acute vascular occlusion during surgery and the rate of restenosis after surgery., and reduces serious complications such as irregular plaque rupture, lumen enlargement, intimal tearing, and dissection.

Scope of Application

Cutting Balloon SystemSuitable for patients with atherosclerotic plaques in coronary arteries requiring cutting treatment.，Patients Acceptable for Coronary Artery Bypass Grafting (CABG) in Emergency Situations。

In addition, the target lesion should also have the following characteristics:: Localized lesions with a lesion length ≤20mm;Reference Vessel Diameter (RVD) is 2.00mm-4.00mm; the device can be easily advanced; the proximal vessel segment has mild or moderate tortuosity; the lesion segment is non-angulated (<45°); the angiographic contour is smooth; and there is no visible thrombus on angiography.

# First Clinical Trial

April 25, 2023Meizhou People's HospitalThe launch meeting for the pre-market registration clinical trial of Shanghai Shenqi Medical Technology Co., Ltd.'s new generation cutting balloon system, Qi Rui - CRipper™, was held, marking the start led by Professor Zhong Zhixiong.Multicenter Study Officially Launched。

On April 26, Meizhou People's Hospital completed the registration clinical trial.First Patient Enrolled, Professor Zhong Zhi-xiong and the Cardiovascular Team of Meizhou People's HospitalSuccessfully performed cutting balloon angioplasty and coronary stent implantation on a patient with severe coronary artery stenosis.The team worked closely together, and the surgery proceeded smoothly.

Patient Basic Information

A 69-year-old male visited the hospital due to recurrent chest tightness and shortness of breath lasting four years. After a thorough examination, he was diagnosed with coronary artery disease, experiencing unstable angina. Multiple cardiovascular areas were affected, including the D1 segment of the left anterior descending artery, the circumflex artery, and the right coronary artery.There are stenotic lesions of varying degrees, with some stenosis reaching up to 85%, categorizing the patient as having severe coronary artery stenosis.。

Surgical Procedure

Professor Zhong Zhixiong's Team Utilizes QiRui-Cripper^TM, performed cutting balloon angioplasty and coronary stent implantation for the patient. Surgical expertA balloon measuring only 2.75mm×10mm was advanced along a guidewire to the mid-section lesion of the right coronary artery, successfully completing the vascular dilation.。

Review angiography shows,The residual stenosis degree of the target lesion in the middle segment of the right coronary artery is 30%, which is significantly relieved compared to the previous stenosis condition.. One drug-eluting stent was implanted successfully, and the surgery was completed smoothly. The patient recovered well post-operation and was discharged after 3 days of rehabilitation.

# Introduction to Similar Competitive Products

The main imported products used in China areBoston Scientific's Wolverine Cutting Balloon, using the NC Emerge balloon platform, with 3 or 4 microsurgical blades (height 0.22-0.33mm; featuring a T-shaped bottom groove design to enhance blade flexibility and secure attachment to the balloon) evenly distributed longitudinally on a non-compliant nylon balloon.

The balloon is suitable for five types of lesions., including oral and bifurcation lesions, calcified lesions, in-stent restenosis, fibrotic lesions, small vessel lesions, can reduce plaque migration, incise mild to moderate calcification, prevent balloon slippage, alter lesion compliance, and reduce the occurrence of restenosis.

Wolverine Cutting Balloon Diagram

LePu MedicalVesscide Cutting Balloon was approved in December 2020, as the first cutting balloon produced in China., covering vascular diameters ranging from 2.00mm to 4.00mm.27 Product Specifications。

The surface of the Vesscide cutting balloon is longitudinally equipped with 3-4 rows of microblades. Before the cutting balloon reaches the lesion, the blades are tightly wrapped within the balloon material, ensuring no harm to normal blood vessels.Compared with traditional balloons,Vesscide Cutting Balloon has significant expansion advantages in treating primary vascular lesions, in-stent restenosis, and vascular ostial and bifurcation lesions.。

Vesscide Cutting Balloon Diagram

Coronary Cutting Balloon of Beijing Baiyi Hui Health Technology Co., Ltd. Approved for Marketing in August 2024, the product isRapid Exchange Balloon Dilation Catheter, mainly composed of a balloon, outer tube, inner tube, tube hub, radiopaque marker, tip tube, buffer tube, etc. The distal outer tube is coated with a hydrophilic coating, and 3 or 4 sets of stainless steel blades are longitudinally mounted on the balloon.The product is suitable for patients with atherosclerotic plaques in the coronary arteries that require cutting treatment and for patients who may undergo coronary artery bypass grafting in emergency situations.。

# About Shenqi Medical

Shanghai Shenqi Medical Technology Co., Ltd. was established in September 2014 and is located in Shanghai Zhangjiang Science City. It is a high-tech medical device enterprise integrating research and development, production, and sales.The company also owns a non-wholly owned subsidiary, Beijing Hartkare Medical Technology Co., Ltd. ("Hartkare®"), which is the first enterprise in China to research, develop, and produce heart failure ultrafiltration treatment equipment.

The company focuses on the high-value consumables product field, with products covering four major sectors: cardiovascular intervention, peripheral vascular intervention, neurovascular intervention, and structural heart disease.. CurrentlyWith 3 marketed products and 32 products under development, all independently developed.

December 2019,swide® Qi Ji® Drug-Coated Coronary Balloon Catheter Obtains NMPA Registration Certificate,Currently, it has entered more than 1,100 hospitals across China.；
Drug-Coated Coronary Balloon Catheter
January 2022SQ-WindRider® Qi Yi® Detachable Fibered Coil Embolization System Obtains NMPA Registration Certificate;
In August 2021, SQ-Kyrin® Shenqi Qi Lin® Transcatheter Mitral Valve Clip and Steerable Guiding Catheter entered the special approval channel for innovative medical devices in China.

In addition to drug-coated balloons, Shenqi Medical has also made relevant advancements in the field of structural heart disease treatment, such as launchingLeft Atrial Appendage Occluder System and Mitral Valve Repair/Replacement Products。

As of the date of publication, the company's financing history is as follows:

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