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InVera Medical's CE Mark Approval: A Leap in Venous Treatment

InVera Medical, an Irish medtech company, has recently accomplished a significant milestone by obtaining European CE Mark approval for its latest medical device designed specifically for the treatment of venous diseases. This innovative technology offers a minimally invasive option that promises to revolutionize the way physicians manage chronic venous conditions, including painful varicose veins.

The Significance of CE Mark Approval

The CE Mark certification allows InVera Medical to market and utilize its infusion device throughout the European Union. This is particularly crucial as chronic venous disease affects approximately one in four adults, leading in severe cases to visible varicose veins or painful ulcers. Alarmingly, while over 120 million people in Europe and the United States suffer from venous disorders, only about 1% of these individuals receive any intervention annually, highlighting an urgent need for improved treatment options.

How the Device Works

The standout feature of InVera's device is its non-thermal approach, contrasting sharply with many existing treatments that involve thermal ablation techniques. The procedure can be performed in a standard medical office setting, requiring only a single injection of local anesthesia, thus avoiding the need for costly hospital equipment. Using a thin catheter inserted under ultrasound guidance, the device facilitates the infusion of medically-approved substances directly into the affected veins, a method already familiar to many healthcare practitioners.

A Vision for Improved Patient Outcomes

Stephen Cox, the CEO and co-founder of InVera Medical, expressed his enthusiasm about achieving CE Mark status, stating, "This is a pivotal milestone for InVera Medical and an important step towards making this technology accessible to patients across Europe. We aimed to develop a less invasive, effective non-thermal approach that seamlessly integrates into existing clinical practices while elevating the treatment experiences for both doctors and patients."

Established in 2018, InVera Medical is committed to pioneering catheter-based technologies for venous conditions, utilizing a patient-centric innovation approach backed by scientific research to ensure safety and effectiveness in medical products. While the InVera Infusion Device is now officially CE marked for use in Europe, it remains unavailable in the U.S. and other international markets.

As healthcare continues to evolve, innovations like InVera’s device represent hope for millions affected by chronic venous diseases, addressing a substantial gap in treatment availability and effectiveness.

For further information, you can explore their official website at inveramedical.com.