FDA Breakthrough Device Designation for Aortix

Procyrion Inc.’s Aortix – a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) with worsening renal function device – has received Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).

Breakthrough Designation is granted to certain medical devices and device-led combination products that provide a more effective treatment of life-threatening or irreversibly debilitating diseases. It enables manufacturers to provide patients and healthcare providers with timely access to medical devices by expediting their development, assessment, and review. Benefits of this designation include frequent interactions and feedback from FDA during the premarket review phase and Procyrion can expect prioritized review of its FDA submissions for the Aortix system.

TMD featured Procyrion and its Aortix system on the cover of the June 2014 issue;
Helping the heart heal itself
Rapid prototyping accelerates development of a circulatory support pump – Aortix – that once implanted, will let the heart rest and heal without surgery.

“We believe Aortix addresses an important unmet clinical need and can fill a major gap ineffective therapy options that are available for heart failure patients. This is particularly critical as this large patient population has high rates of rehospitalization and death, long lengths of stay in the hospital and high healthcare costs,” says Eric S. Fain, MD, president and CEO of Procyrion. “We plan to fully leverage the benefits of FDA Breakthrough Device designation as we seek to accelerate the U.S. clinical and regulatory process with the goal of providing physicians and patients with the benefits of our novel device.”

Heart failure (HF) is common, affecting more than 6 million adults and resulting in over 1 million annual hospitalizations in the United States alone. HF costs the nation an estimated $30.7 billion each year. HF is a chronic, progressive condition, marked by episodes of acute decompensation typically requiring hospitalization for stabilization and improvement in symptoms. Unfortunately, outcomes after a hospitalization for decompensated heart failure are poor. The 1-year mortality rate after a heart failure hospitalization has remained high at 20-30%, and there is additive risk with each subsequent hospitalization. In addition, at least moderate renal dysfunction (Stage III) is present in up to 64% of ADHF admissions and it is estimated that over 325,000 admissions per year in the U.S. are for patients with ADHF who also have worsening renal function. These patients represent a particularly high-risk population as they are frequently non-responders to available medical therapy and have poor outcomes.

The Aortix System is a percutaneous circulatory support device for the treatment of heart failure. The initial version of the Aortix device provides up to 7 days of circulatory support for chronic heart failure patients who have been hospitalized for ADHF, have worsening renal function and are unresponsive to medical management. As demonstrated in animal studies and a 6-patient First-in-Human study, Aortix benefits both the heart and the kidneys based on its unique design and placement in the descending thoracic aorta. Aortix can disrupt the harmful cardiorenal cycle in two ways: above the pump, it rests the heart by reducing aortic root pressure (afterload) resulting in increased cardiac output and decreased cardiac work; downstream, it provides increased blood flow to the kidneys resulting in increased urine output and a reduction in fluid overload. The device is placed via a minimally invasive catheter-based procedure that takes less than 10 minutes.