Ballet® Vena Cava Filter Completes First-in-China Clinical Implantation at the First Hospital of Hebei Medical University

Shijiazhuang, November 12, 2019 /PRNewswire/ -- The Ballet® retrievable vena cava filter, innovatively developed by Hangzhou Wei Qiang Medical Technology Co., Ltd. (hereinafter referred to as "Wei Qiang Medical"), a subsidiary of Deno Medical, was implanted in its first clinical case in China at the First Hospital of Hebei Medical University on September 27, 2019, and was successfully retrieved on November 5, 2019. The procedure was performed by a team led by Dr. Zhang Lei, Director of the Department of Vascular Surgery at the First Hospital of Hebei Medical University, together with He Xinqi and Zheng Lihua. Following the procedure, Dr. Zhang Lei stated, "While effectively preventing pulmonary embolism, the Ballet® vena cava filter demonstrated safe and stable placement, accurate positioning, and no displacement. The centrally located retrieval hook facilitated easy retrieval with minimal resistance, and there was no significant damage to the vascular intima, meeting the clinical requirements physicians have for inferior vena cava filters."

The successful completion of this surgery has brought a safer and more effective therapeutic product to patients with inferior vena cava thrombosis in China, while also demonstrating that domestically produced medical devices are steadily advancing to rival global standards.。

Background Information:

Preoperative color Doppler ultrasound revealed deep vein thrombosis in the right lower extremity. Intraoperatively, the Ballet® inferior vena cava (IVC) filter was delivered via the jugular vein approach into the IVC. The device was accurately positioned and stably deployed, with safe withdrawal of the delivery system. No intraoperative complications or adverse events occurred. Immediate post-deployment angiography demonstrated a centrally located retrieval hook, no vascular wall perforation, and patent IVC blood flow. The filter was retrieved after 39 days of implantation. Angiography at retrieval showed no filter migration, a centrally positioned retrieval hook, no vascular perforation, and smooth venous walls. Post-retrieval inspection of the filter revealed no significant endothelial tissue adherence or thrombus formation.

Pulmonary embolism is an acute-onset disease with a high case fatality rate, most commonly caused by the detachment of thromboemboli from deep vein thrombosis in the lower extremities. Clinical manifestations include sudden chest pain, chest tightness, dyspnea, and cyanosis; severe cases may progress to shock or even death. The annual incidence is 100–200 per 100,000 population, and the 30-day all-cause mortality rate is 9%–11%. Inferior vena cava filter implantation is an effective measure to prevent fatal pulmonary embolism caused by thrombus detachment, while ensuring patency of inferior vena cava blood flow.

Currently, filters used in clinical practice are generally categorized into three types: permanent filters, temporary filters, and retrievable filters. The Ballet® inferior vena cava filter, innovatively developed by Wei Qiang Medical, effectively combines the advantages of both permanent and temporary filters. The current retrieval time window for domestically produced filters is2 Weeks, failing to meet the clinical requirement for filter dwell time (no less than 2 months), whereas the retrieval window for the Ballet® vena cava filter exceeds 2 months.

Animal study evaluation results demonstrated that the Ballet® vena cava filter exhibited superior thrombus capture rates compared to similar products, with no migration or tilting observed. Complete retrieval was achieved in 100% of cases at six months post-implantation, with no failures. No significant vascular intimal injury or thrombosis was noted.

The design features of the Ballet® vena cava filter are as follows:

1. A delivery system capable of simultaneous transjugular/transfemoral bidirectional deployment and retrieval, with effective thrombus interception.
2. Self-centering support layer for anti-tilt; self-centering capability effectively prevents filter tilting and keeps the retrieval hook from contacting the vessel wall.
3. Bidirectional barb design effectively prevents filter migration after implantation.
4. The delivery device is flexibly connected to the filter, allowing for repositioning.
5. Curved retrieval hook for easy capture.

Director Zhao Jun, the principal investigator for the Ballet® IVC Filter, stated: “The Ballet® IVC Filter, innovatively developed by Wei Qiang Medical, is a self-centering filter that allows for controlled deployment and retrieval via both jugular and femoral approaches. It effectively captures emboli regardless of whether it is positioned upright or inverted, thereby preventing pulmonary embolism. The Ballet® IVC Filter incorporates technological innovations and design improvements based on the clinical experience of Chinese physicians. With fully independent intellectual property rights, the product exemplifies the international standard of China’s ‘intelligent’ manufacturing.”

Recently, a prospective, multicenter, randomized controlled clinical trial, led by Shanghai Sixth People's Hospital and Zhongshan Hospital Fudan University, has officially commenced in China.

As of press time, a total of 13 clinical implantations of the Ballet® vena cava filter have been completed nationwide.