- In June 2024, Royal Philips launched the FDA-approved Duo Venous Stent System, designed to treat symptomatic venous outflow obstruction in patients with chronic venous insufficiency. Featuring Duo Hybrid and Duo Extend stents, the system demonstrated strong clinical outcomes, including a 90.2% 12-month primary patency in the VIVID trial. This launch underscores Philips' commitment to offering innovative and effective minimally invasive solutions for venous diseases, reinforcing its leadership in vascular care technologies
- In April 2023, the U.S. FDA granted Investigational Device Exemption (IDE) approval for the VEINRESET pivotal trial evaluating Sonovein, a high-intensity focused ultrasound (HIFU) system developed by Theraclion. This trial aims to explore a completely non-invasive approach to treating superficial venous reflux. The regulatory milestone highlights growing interest in non-thermal, non-invasive treatment modalities and reflects Sonovein’s potential to reshape the future of venous disease management
- In December 2023, Theraclion completed the patient enrollment phase for its Sonovein FDA pivotal trial, marking a key milestone toward regulatory approval. The company announced that the 12-month follow-up phase was underway, with data and submission to the FDA expected by mid-2025. This progress showcases continued momentum for HIFU as a promising alternative to conventional endovenous therapies
- In March 2024, enVVeno Medical reported continued advancement in the development of its VenoValve, a surgically implanted device designed to restore valve function in patients with chronic venous insufficiency. The device is currently under evaluation in the U.S.-based SAVVE pivotal trial, with the company also progressing its transcatheter-based enVVe valve. This dual-platform strategy highlights enVVeno’s dedication to addressing unmet needs in both surgical and catheter-based venous valve repair
- In April 2024, AngioDynamics, Inc. received expanded FDA clearance for its AlphaVac F18 System, now approved for the removal of pulmonary emboli in addition to its original indication for venous thromboemboli. This approval broadens the therapeutic utility of the system and reinforces AngioDynamics’ role in offering versatile and innovative solutions for the treatment of complex venous thrombotic conditions
