Shanghai Xuanyu Medical's StrenSoft™ Adjustable Pulmonary Artery Thrombectomy Stent System Gains NMPA Approval

Recently, the National Medical Products Administration approved Shanghai ShineyoMedical Co., Ltd. (hereinafter referred to as: ShineyoMedical)'sAdjustable Curved Pulmonary Artery Embolectomy Stent SystemRegistration Application for This Innovative Product: Another Domestically Produced Innovative Interventional Device Hits the Market.

Image Source: NMPA Official Website

01

Successfully Approved

Adjustable Curved Pulmonary Artery Embolectomy Stent System

ShineyoMedical, established in 2020, leverages its three independently developed R&D platforms for active medical devices, vascular interventional catheters, and biomaterials to enterCardiac ElectrophysiologyandPeripheral Vascular InterventionOperating in these two high-potential sectors, the company is a leading Chinese innovative medical device enterprise with a dual-platform layout in electrophysiology and peripheral vascular intervention. According to data from the Yaozhi Data - Investment Landscape Database, ShineyoMedical has completed multiple rounds of financing, with several rounds nearing RMB 100 million, helping ShineyoMedical build a differentiated portfolio of cardiac electrophysiology and peripheral vascular intervention products.

The product approved for ShineyoMedical this time isStrenSoft™ Adjustable-Curved Pulmonary Artery Thrombectomy Stent System, the product entered the innovation channel on April 27 last year and was finally approved for market launch recently after one year.

Image source: CMDE official website

According to the NMPA, this product is divided intoSteerable and Coated Types, consisting of a thrombectomy stent catheter, an aspiration catheter, and accessories. It is indicated for catheter-based thrombus removal treatment in patients with acute high-risk pulmonary embolism or intermediate-risk pulmonary embolism with clinical deterioration, who have thrombi in the main pulmonary artery or its major branches and either present a high risk of bleeding or have contraindications to thrombolysis, or have failed thrombolysis or aggressive medical therapy.

Currently, due to factors such as improved national health awareness and diagnostic consciousness, the annual number of new pulmonary embolism cases in China has been increasing year by year, with a relatively significant growth rate. Consequently, the market share for pulmonary embolism treatment is also on a growth trajectory, surging annually. With the continuous improvement of China’s medical device research and development capabilities, an increasing number of pulmonary artery embolectomy products have been approved for market launch. According to data from Yaozhi Medical Devices, at least several such products are currently available in the Chinese market.Six Pulmonary Embolectomy Systems / Pulmonary Embolectomy Stent Systems(The figure below does not include the products launched this time).

Image source: Yaozhi Medical Device Data

Compared to the series of products already on the market, ShineyoMedical’s newly launched product also features its differentiated characteristics. According to previous announcements by ShineyoMedical, the steerable pulmonary artery embolectomy stent systemNo Need for Extracorporeal Shaping, the procedure is more efficient, enabling rapid mechanical thrombectomy with a shorter treatment time and faster efficacy, thereby reducing patient risk and providing a new option in the field of pulmonary embolism treatment.

02

Dual-Platform Layout

Multiple Innovative Medical Devices Launched

Notably, ShineyoMedical has had multiple innovative devices approved for market launch for two consecutive years. According to data from Yaozhi Medical Devices, in addition to the product recently approved for marketing, currently ShineyoMedicalThree products have been approved for marketing in China., among which on February 26, 2025, its innovative medical devices—the SHINERHYTHM™ Cardiac Pulsed Field Ablation System and the RHYTHPULSE™ Disposable Cardiac Pulsed Field Ablation Catheter—were also approved for market launch.

Image source: Yaozhi Medical Device Data

It is understood that,SHINERHYTHM™ Cardiac Pulsed Field Ablation SystemandRHYTHPULSE™ Disposable Cardiac Pulsed Field Ablation CatheterHigh-voltage pulsed electric fields can be utilized to ablate atrial fibrillation, inducing irreversible electroporation in pathological cells, leading to necrosis or apoptosis.

Image Source: ShineyoMedical Official Website

Compared with traditional radiofrequency ablation or cryoablation techniques, ShineyoMedical’s products are distinguished by their ability to selectively destroy myocardial tissue, thereby avoiding the risk of collateral damage to surrounding tissues caused by thermal conduction. This enables more patients with drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation to benefit from the treatment.

In addition to the PFA sector, ShineyoMedical is also strengthening its product pipeline in the peripheral vascular intervention field. The steerable pulmonary artery embolectomy stent system launched this time is just one part of its layout in the peripheral vascular intervention domain.

Among them, VariSeal^®Venous closure systems are also one of ShineyoMedical's flagship products, utilizingVaricose Vein Treatmentinnovative therapy, consisting of an adhesive and a delivery system. Moreover, the product's original“Red Light Navigation + 0.1ml Precise Gel Injection”The technology provides intuitive and clear navigation guidance for the operator, enabling precise micro-injection of adhesive with an accuracy of 0.1 mL, thereby achieving the clinical objective of accurately occluding superficial veins of the lower extremities.

Image source: ShineyoMedical official website

03

Conclusion

In recent years, ShineyoMedical has pursued a dual-pronged strategy, achieving multiple breakthroughs in both the pulsed field ablation (PFA) and peripheral vascular intervention fields, with continuous implementation of innovative outcomes. Supported by favorable policies and driven by ongoing technological advancements, the value proposition of domestically produced medical devices is increasingly recognized, as local medical device manufacturers continue to shine with renewed vitality.

Reference: ShineyoMedical Official WeChat Account