Ballet® (Ballet) Vena Cava Filter Achieves First Successful Clinical Application at Shanghai Sixth People's Hospital

Shanghai, January 8, 2020 /PRNewswire/ -- On November 8, 2019, the latest generation of inferior vena cava (IVC) filter, designed to prevent fatal pulmonary embolism, was successfully implanted into the vena cava of a patient with deep vein thrombosis (DVT) in the lower extremities by the Department of Vascular Surgery at Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University (hereinafter referred to as "Shanghai Sixth Hospital"). After remaining in the body for 56 days and eliminating the risk of pulmonary embolism, the filter was successfully retrieved. This marks the culmination of four years of industry-academia-research collaboration between Hangzhou Wei Qiang Medical Technology Co., Ltd., under the Deno Medical Group, and the Department of Vascular Surgery at Shanghai Sixth Hospital, resulting in the development of the Ballet^®(Ballet) retrievable vena cava filter successfully applied in clinical practice at the pioneering research institution (Figure 1).

The patient is a 54-year-old male who presented to Shanghai Sixth People’s Hospital with sudden onset of swelling and pain in his left lower extremity for five days. Color Doppler ultrasound revealed deep vein thrombosis (DVT) in the lower extremity. Due to the large thrombus burden during the acute progressive phase, an inferior vena cava (IVC) filter was required to be placed prior to thrombectomy to prevent fatal pulmonary embolism during the procedure. The hospital’s Department of Vascular Surgery assessed that the patient was suitable for the latest type ofBallet^®(Ballet) Indications for Inferior Vena Cava Filter Placement. Therefore, the conventional transfemoral venous puncture approach was adopted to“The "Ballet" filter was successfully delivered to the inferior vena cava and deployed after accurate positioning. No complications or adverse reactions occurred during the procedure. Immediate postoperative angiography demonstrated accurate filter placement, good configuration, and patent blood flow in the inferior vena cava. Following subsequent thrombectomy and adequate anticoagulation therapy, the thrombus resolved after 56 days, allowing for filter retrieval. Intraoperative angiography showed no filter displacement, no tilting, and no vascular injury. The filter was successfully retrieved using a snare device (Figure 2-3）。

Zhao Jun, Director of the Department of Vascular Surgery at Shanghai Sixth People's Hospital, stated: “Ballet^®(Ballet) The Ballet inferior vena cava (IVC) filter is the first domestically developed, highly efficient retrievable IVC filter featuring bidirectional deployment and retrieval, as well as anti-tilt and anti-migration capabilities, effectively preventing fatal pulmonary embolism. Many currently used filter models are prone to tilting, deformation, and migration after prolonged implantation.^®The filter’s “flower-roll-shaped” double-layer support structure provides effective support to prevent tilting and maintain its optimal shape, while bidirectional barbs effectively prevent migration.Figure 4）。Ballet^®The filter incorporates technological innovations and design improvements based on the clinical experience of Chinese physicians. The product possesses fully independent intellectual property rights, reflecting China's‘Intelligent Manufacturing’international standards.”

Ballet^®(Ballet) vena cava filter receives national approval to commence clinical trials. This study is a prospective, multicenter, randomized controlled clinical trial led by Shanghai Jiao Tong University Affiliated Sixth People's Hospital and Fudan University Affiliated Zhongshan Hospital, with participation from twenty-five hospitals across China, aiming to enroll 144 patients. As of press time, more than twenty patients have been successfully enrolled and received treatment using the latest high-efficiency, low-risk medical device. The expected clinical enrollment target is anticipated to be completed within several months.