InVera Medical Achieves CE Mark Approval for Groundbreaking Infusion Device
In a notable advancement for medical technology, InVera Medical, an Irish company specializing in catheter-based procedures, has successfully obtained the European CE mark approval for its latest venous infusion device. This innovative and minimally invasive device is specifically designed to enable healthcare professionals to provide more effective treatments for patients with chronic vein conditions, particularly targeting issues related to varicose veins.
The CE mark approval is a significant regulatory milestone that allows InVera's device to be marketed and utilized across the European Union. Unlike many existing treatment methods that employ thermal ablation to treat varicose veins, InVera Medical’s approach involves a non-thermal infusion technique. This method not only enhances patient comfort but also minimizes the invasiveness of the procedure, making it a prime alternative in the treatment landscape.
The procedure can be performed conveniently in an office setting and requires only a local anesthetic injection, eliminating the need for specialized hospital equipment. This flexibility represents a substantial breakthrough in expanding non-thermal treatment options available to medical professionals managing chronic venous diseases.
At the heart of the device is a slender catheter, which is inserted into the affected vein under ultrasound guidance. This technique is already familiar to many healthcare providers, enhancing its feasibility for widespread clinical application. By utilizing this device, physicians can more effectively infuse specific agents, tailoring their approach to individual patient needs.
Chronic venous disease, a condition affecting approximately 25% of adults, can lead to serious complications such as painful ulcers if untreated. Despite the fact that it impacts over 120 million individuals in Europe and the United States, only about 1% of those suffering from chronic vein ailments receive any form of interventional treatment annually. This statistic highlights a significant gap in healthcare delivery that InVera Medical aims to address through its innovative solution.
Stephen Cox, CEO and co-founder of InVera Medical, emphasized the importance of this CE mark approval, stating, “Obtaining the CE mark is a pivotal achievement for InVera Medical and represents a major step forward in making this technology accessible to patients across Europe. Our focus has been on developing a non-thermal, less invasive approach that seamlessly integrates into current clinical practices, all while improving the treatment experience for both healthcare providers and patients.”
Founded in 2018, InVera Medical is dedicated to creating safe and effective medical devices aimed at treating venous diseases. The company’s mission is rooted in a patient-centered approach, driven by scientific research to fuel innovation in medical technology. The newly approved InVera infusion device is currently available for use in the European Union but is not yet on the market in the United States or other international regions.
For more information on InVera Medical and their latest innovations, visit
www.inveramedical.com.