Transcatheter Device for Congestive Heart Failure Treatment Through Left Atrial Decompression

ABSTRACT Chronic heart failure (CHF) is a chronic and progressive condition that currently affects over 6 million patients in the US. It accounts for over $35B in annual healthcare expenditure and is responsible for over one million hospitalizations each year. CHF is a chronic and progressive condition in which the heart is unable to pump enough blood to maintain adequate circulation - the heart is failing to meet the body’s needs. Approximately half of all patients with CHF have a left ventricular ejection fraction greater than 40% and are categorized as having heart failure with preserved ejection fraction (HFpEF, EF ≥ 50%) or mid-range ejection fraction (HFmrEF, 40% ≤ EF < 50%). The prognosis for these patients is poor: due to a paucity of treatment options, patients have 5- year and 10-year mortality rates of 50% and 90%, respectively. Although existing pharmacological therapies have demonstrated symptomatic improvement and mortality benefit in patients with HFrEF there are currently limited FDA-approved treatment options (pharmacological or device-based) for the HFpEF patient population. The concept of interatrial shunting has gained attention as a potential therapeutic option for patients with CHF. By creating a connection between the high-pressure left atrium to the low-pressure right atrium elevated left atrial pressure (LAP) may be effectively lowered thereby relieving CHF symptoms. Recently, several implantable interatrial shunt devices have been shown to enable left atrial to right atrial blood flow, resulting in left atrial decompression, a reduction in CHF symptoms, and improved quality of life in a number of promising human clinical studies. Nonetheless intracardiac implants carry proven clinical risks including clot formation device fracture, migration, and implantation failure. There is currently no device available that can provide therapeutic left atrial decompression without the long-term clinical risks and concerns of leaving behind a foreign body in the heart. Alleviant Medical has developed a novel transcatheter approach to relieve left atrial pressure by creating an interatrial shunt without the need for a cardiac implant. Alleviant’s received FDA IDE approval following results from device verification testing and results from the first-in-human clinical study to investigate the safety and efficacy of a no-implant interatrial shunt for patients with heart failure. The goal of this proposal is three aims: (1) to complete the testing of the ALV1 System, (2) develop necessary clinical screening and device procedure training programs, and (3) submit a US PMA application to market the ALV1 System for alleviating symptoms associated with elevated LAP in the HFpEF/HFmrEF patient population. To achieve this goal, Alleviant will establish key verification test data demonstrating the reliability of the device in accordance with all internal risk management and design control procedures and regulatory requirements. The Alleviant System is Class III in the US and requires PMA approval. The methodology for this proposal will follow a risk-based product development process and ISO Standard testing. Successful execution of this Phase IIB proposal will result in an FDA PMA submission and commercialization of the ALV1 System.