Revivent transcatheter system receives Breakthrough Device Designation from the FDA

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Revivent TC System

The Revivent transcatheter ventricular enhancement system (Bioventrix) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA). The Revivent investigational transcatheter device uses micro-anchors to cinch together the scarred area of the left ventricle to improve heart function.

In a press release, Bioventrix explains that the Less Invasive Ventricular Enhancement (LIVE) procedure uses the Revivent TC System to exclude scar tissue on the left ventricle that has resulted from a heart attack, allowing the healthy portion of the heart to function more efficiently. Micro-anchors are implanted and designed to remodel the heart to a more normal shape and size and reduce wall stress, which has the potential to improve blood flow throughout the body.

The Revivent TC device is currently being studied in its pivotal trial – the ALIVE Trial – across the USA to determine whehter a less invasive device can improve heart function, symptoms and quality of life. The trial is currently enrolling up to 120 patients at up to 20 US sites with a primary endpoint analysis at one year. The system has received the CE Mark and is commercially available in Europe.

Principal investigator for the ALIVE trial Andrew Wechsler (Drexel University College of Medicine, Philadelphia, USA) says in the press release: “Current methods for surgical remodeling of the ventricle are effective, but highly invasive, and not well tolerated by patients. Having a less invasive method to treat the ventricle enables more patients to benefit from a more efficient heart.”

BioVentrix CEO Ken Miller adds: “The breakthrough designation for the Revivent TC System recognises that many patients suffering from heart failure are at risk of death without a less invasive way to address their left ventricular damage. Being part of the Breakthrough Devices Programme should help to speed the FDA’s evaluation and, ultimately, market entry, so more patients can be helped more quickly.”

The Breakthrough Devices Programme is a voluntary programme for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the Breakthrough Devices Programme is to provide patients and healthcare providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the Agency’s mission to protect and promote public health.


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