Boston Scientific's JETSTREAM Atherectomy System Receives NMPA Approval in China

August 28Shanghai, China — Recently, Boston Scientific announced that its comprehensive solution for peripheral artery disease (PAD), the JETSTREAM Atherectomy System, has officially received approval from the National Medical Products Administration (NMPA). The system is suitable for peripheral arterial plaque removal and is a debulking device with active aspiration and perfusion functions. It has the ability to remove different types of lesions such as fibrous plaques and calcified plaques, which can reduce the degree of internal vascular stenosis. It is suitable for percutaneous transluminal plaque excision pretreatment of primary lesions in the femoral-popliteal arteries, improving vascular patency. This provides a new solution for reducing the medical burden of peripheral vascular diseases in China.

With the improvement of living standards, the deepening of population aging, and the impact of unhealthy lifestyles, the incidence of peripheral artery disease continues to rise. It is estimated that there are 45.3 million patients with peripheral artery disease in China, and the disease burden caused by it is also continuously increasing.1Specifically, patients with peripheral artery disease often suffer from insufficient blood supply to the upper and lower limbs (commonly in the lower limbs) and exhibit a variety of lesion types, such as diffuse vascular lesions, severe stenosis, or even complete occlusion. Minimally invasive intervention, as a commonly used treatment solution for such lesions, has the advantages of high surgical efficiency, minimal trauma, and fast recovery, making it an effective means to improve clinical treatment efficiency. However, these diseases are often complicated by deposits such as calcification, plaque, and thrombus, and during endovascular treatment, single-function debulking devices have limited effectiveness in addressing such complex lesions.

JETSTREAM Atherectomy System Combines Front-Cutting Tip, Active Aspiration System, and Lateral Expansion Blade in "Three-in-One" Design, Capable of Grinding Calcifications, Excising Plaques, and Aspirating Debris While Offering Flexible Treatment Size Options to Maximize Luminal Gain.2.The system also features differentiated cutting technology, which ensures that when high-speed rotational grinding of calcified areas and plaque cutting is performed, the vascular walls and other soft tissues are not damaged, better guaranteeing the safety of patients during surgery.

Real-world clinical data shows that the overall surgical success rate (postoperative residual stenosis ≤30%) of patients using the JETSTREAM Atherectomy System is as high as 98.3%; the proportion of immediate lumen area improvement after surgery is 86%; when combined with Drug-Coated Balloons (DCB), the long-term efficacy at 18 months post-surgery shows a Target Lesion Revascularization (TLR)-free rate of 91%.345。

Boston Scientific China Vice President Da Bo said: "The JETSTREAM Atherectomy System has previously been selected for the National Medical Products Administration's 'Innovation Channel,' which is a great affirmation of our product's innovation and clinical value."6As the only debulking device approved by the National Medical Products Administration (NMPA) with both active aspiration and plaque excision functions, it will provide a more reliable and convenient option for vessel preparation in complex lower extremity arterial lesions. From now on, Boston Scientific has also become one of the few medical technology companies to offer comprehensive product solutions from vessel access, vessel preparation, to luminal treatment, bringing more advanced medical options to patients with peripheral artery disease. In the future, Boston Scientific will continue to focus on patients, adhere to effective innovation, and promote the alignment of minimally invasive interventional technologies in China with international frontiers."So far, the JETSTREAM Atherectomy System has been approved for use in Europe, the United States, Asia-Pacific, and other regions.

1. National Center for Cardiovascular Diseases, Writing Group of the Report on Cardiovascular Health and Diseases in China. Summary of the Report on Cardiovascular Health and Diseases in China 2023[J]. Chinese Circulation Journal, 2024, 39(7): 625-660. DOI: 10.3969/j.issn.1000-3614.2024.07.001

2. Only some models have "lateral expansion blades".

3. Garcia, L. (2017). JETSTREAM atherectomy in treating de novo or non-stent restenotic femoropopliteal disease: One-year results from the JET registry. Registry results presented at the Leipzig Interventional Course (LINC), Leipzig, Germany.

4.Maehara A, et al. Intravascular ultrasound evaluation of JETSTREAM atherectomy removal of superficial calcium in peripheral arteries. EuroIntervention 2015;11:96-103.

5.Shammas, N (2017). Long Term Outcomes with JETSTREAM Atherectomy System with or without Drug Coated Balloons in Treating Femoropopliteal Arteries: A Single Center Experience (JET-SCE). JET-SCE results presented as a poster at Society for Cardiovascular Angiography and Interventions (SCAI) Scientific Sessions, New Orleans, LA.

6. "Innovation Channel": Special Review Procedure for Innovative Medical Devices

7. As of the date of publication