#Ireland #Galway #CE Mark #InVera Medical #vein infusion

InVera Medical Secures CE Mark Approval for Innovative Vein Infusion Device

InVera Medical, a pioneering medical technology company from Ireland, has achieved a significant milestone by obtaining the CE Mark approval for its new vein infusion device. This innovative device is designed to treat diseased leg veins, particularly focusing on conditions such as varicose veins, using a minimally invasive approach. This regulatory approval enables the company to market and utilize the InVera Infusion Device across the European Union, marking a crucial step towards enhancing treatment accessibility in the healthcare sector.

The InVera device distinguishes itself from traditional vein treatment technologies, which typically employ thermal methods that can be invasive and require extensive hospital resources. Instead, the InVera Infusion Device utilizes a non-thermal methodology, allowing the procedure to take place conveniently within a doctor's office. This shift towards a less invasive technique is expected to improve patient comfort, requiring only a single local anesthetic injection without the need for specialized hospital equipment.

The procedure involves the insertion of a slender catheter guided by ultrasound, a method that many physicians are familiar with. The catheter is strategically placed into the vein to enhance the infusion of selected therapeutic agents directly where they are needed, improving the efficacy of treatments for Chronic Venous Disease (CVD).

Chronic Venous Disease affects approximately 25% of adults and can evolve from unsightly varicose veins to more serious complications such as painful leg ulcers if left untreated. Despite the considerable number of individuals affected—over 120 million across Europe and the United States—only about 1% receive interventional treatments annually, highlighting a critical gap in care that InVera aims to close.

Stephen Cox, the CEO and Co-Founder of InVera Medical, remarked on the significance of receiving the CE Mark: "This is a major milestone that establishes a pathway for us to provide this innovative technology to patients across Europe. Our commitment has been to develop an effective and less invasive treatment option that easily integrates into existing clinical practices, thereby enhancing treatment experiences for both patients and healthcare providers."

Founded in 2018, InVera Medical is dedicated to innovating catheter-based solutions for vein diseases. The company's driving force is its patient-first philosophy, ensuring that all medical devices are not only safe and effective but also rooted in scientific evidence and patient needs.

The InVera Infusion Device is currently CE Marked for use within the EU, although it is not yet available in the United States or other international markets. This innovation underscores a significant progress in the category of minimally invasive medical treatments, promising improved care for millions suffering from Chronic Venous Disease.

For more information on their products and initiatives, visit InVera Medical's website.