InVera Medical Secures CE Mark Approval for Advanced Vein Infusion Device
InVera Medical, a leading Irish medical technology company, has successfully acquired the European CE mark approval for its groundbreaking vein infusion device. This regulatory authorization marks a pivotal moment for the company and represents a significant leap forward in the treatment of chronic venous diseases, including varicose veins.
The newly approved infusion device is designed to provide a minimally invasive solution for physicians, enabling them to more effectively treat diseased veins in patients' legs. Unlike traditional methods that utilize thermal techniques to ablate veins, InVera's innovative device employs a non-thermal approach. This shift in methodology offers several advantages, including a less invasive procedure that can be performed directly in a physician's office with the need for only a local anesthetic injection.
This device's operation features the use of a slender catheter inserted into the vein under ultrasound guidance—a technique familiar to many medical professionals. It allows for more efficient delivery of physician-specified treatments directly into the vein. This advancement comes at a crucial time, as chronic venous disease (CVD) affects approximately one in four adults, potentially leading from visible varicose veins to painful leg ulcers when untreated.
Despite the high prevalence of CVD, with estimates indicating that over 120 million individuals in Europe and the United States suffer from the condition, current intervention rates are alarmingly low. Approximately only 1% of those affected receive any form of interventional treatment annually, highlighting a significant gap in the available care options. InVera aims to bridge this gap effectively with its cutting-edge technology.
Stephen Cox, the CEO and co-founder of InVera Medical, commented on this milestone achievement, stating, "Obtaining the CE mark is a major milestone for InVera Medical and an important step toward making this technology available to European patients. We are focused on developing an effective, non-thermal approach that seamlessly integrates into existing clinical practices while enhancing the treatment experience for both physicians and patients."
Founded in 2018, InVera Medical specializes in catheter-based technologies aimed at addressing venous diseases. The company's mission is rooted in a scientific approach to innovation in medical devices that prioritizes safety and efficacy, emphasizing patient-centered care.
As it stands, the InVera infusion device is CE marked for use throughout the European Union but is not yet available in the United States or other international markets. This regulatory approval opens doors for InVera Medical to expand its reach and offer innovative solutions to those suffering from chronic venous conditions.
For further details about InVera Medical and its innovative healthcare solutions, visit their official website at
www.inveramedical.com.