Recently, the innovative product Tendvia™ Pulmonary Artery Thrombectomy System of Shanghai Tendfo Medical Device Co., Ltd. is approved by China NMPA.

The Tendvia™ Pulmonary Artery Thrombectomy System contains two parts: a pulmonary artery thrombectomy device and a thrombus aspiration catheter. The pulmonary artery thrombectomy device is coaxially assembled from a delivery sheath and a push tube with a self-expanding mesh basket structure; the thrombus aspiration catheter consists of an aspiration catheter, a catheter core and an aspirator. This device is indicated to be used for transcatheter thrombectomy in acute high-risk pulmonary embolism or intermediate-risk pulmonary embolism accompanied by clinical deterioration under one of the following circumstances: patients with thrombosis in pulmonary artery trunk or main branch who have a high risk of bleeding or contraindication to thrombolysis; and patients with thrombi in the main pulmonary artery or major branches and who have not responded to thrombolysis or active medical treatment.

This product is the first Pulmonary Artery Thrombectomy System for interventional treatment in China. Taking mechanical thrombolysis, this product reduces the use of thrombolytic drugs and provides a treatment option for patients with contraindications to thrombolysis.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.