Key challenges faced by global inferior vena cava (IVC) filter market players include stringent regulatory approval process. The IVC filters are class III medical devices, which require rigorous clinical testing and pre-market approval from regulatory agencies such as the U.S. FDA and European Medicines Agency (EMA) before commercial launch. Getting regulatory approval is a complex, costly, and time-consuming process which involves clinical trials to demonstrate safety and efficacy of new IVC filters. Any changes to design, material or intended use requires additional studies and approvals. This often delays the launch of new and innovative IVC filter devices. The stringent norms also raise compliance requirements, which increase the overall costs for manufacturers. Complying with regulations across different markets also poses geographic expansion challenges for companies.
Market Opportunity: Development of retrievable IVC filters
Development of retrievable IVC filters presents lucrative growth opportunities for the market players. Unlike permanent filters which get embedded in the vein, retrievable filters can be inserted and then removed by a surgeon once the risk of a pulmonary embolism is over. This prevents long-term complications associated with permanent filters. There has been growing clinical evidence which shows potential benefits of retrievable filters over permanent ones. With increasing recognition of their advantages, there has been huge demand for retrievable IVC filters. Market players need to invest in R&D and clinical trials to develop advanced retrievable filters with improved clinical efficacy as well as features such as reduced risk of fracture or migration. Launching easy to retrieve and reposition filters will help companies gain more market share. For instance, in February 2023, Cook Medical secured FDA approval for its Celect Vena Cava Filter, a next-generation retrievable IVC filter. The Celect filter boasts enhanced flexibility and ease of insertion as compared to earlier models, along with a retrieval rate exceeding 90%.
Joining thousands of companies around the world committed to making the Excellent Business Solutions.
View All Our Clients