Development of a Non-Surgical Circulatory Support Device for the Treatment of Chronic Heart Failure

Omar Benavides, PhD, Senior Product Development Engineer; Benjamin Hertzog, PhD, President & CEO; Jason Heuring, PhD, Chief Operating Officer; Reynolds M. Delgado III, MD, Chief Medical Officer; Will Clifton, MD, Director of R & D; Procyrion, Inc., Houston, TX

Procyrion is developing the first catheter-deployed heart pump intended for long-term treatment of chronic heart failure. Thinner than a #2 pencil and only 6 cm long, Aortix™ has the potential to become a low-risk circulatory assist device for a broad range of patients. Aortix was conceived as a therapy to safely treat patients earlier in the progression of heart failure and to significantly improve their quality of life. (See Figure 1)

Fig. 1 – Aortix is the first catheter-deployed micro heart pump designed to rest and heal the heart without surgery and with minimal risk.

Heart failure accounts for 3.6 million hospitalizations, 300,000 deaths, and $35 billion in annual healthcare costs in the US alone. More than 3 million heart failure patients currently suffer from chronic fatigue and painful swelling while performing normal activities of daily living but cannot be managed by medication alone and have no safe and effective therapeutic option.

The only treatments available to these patients are heart transplants, which are limited by scarcity, and surgically implanted pumps called ventricular assist devices (VADs), which are risky, invasive, and so expensive they are only used as a last resort. This leaves more than 2 million people in the US with no choice but to suffer a slow decline in quality of life.

Aortix is a powerful micro-pump designed to rest and heal the heart without surgery and with minimal risk. It is deployed percutaneously in a simple 10-minute catheter lab procedure. First, a cardiologist guides the pump through a deployment sheath in the femoral artery to the descending thoracic aorta. Once in place, the sheath is retracted, allowing self-expanding nickel-titanium struts to deploy and anchor the pump to the aortic wall.

The device accelerates a portion of blood flow within the pump and pushes it downstream to entrain aortic flow. Strategic placement downstream of the heart allows for combined benefit to the heart, kidneys, and other vital organs while eliminating the common VAD risks of damage to the heart and thrombotic stroke. Furthermore, Aortix is the first catheter-based pump suitable for long-term ambulatory use and is non-obstructive to native blood flow, unlike current VADs in which device failure is often fatal. The end result is reduced afterload, the heart working at a sustainable level, and healthy blood flow and pressure throughout the body.

In its current configuration, Aortix is powered through a flexible, transdermal lead that attaches to a pocket-sized microcontroller. The system can operate for more than eight hours on a single charge, but external battery packs are “hot swappable”, meaning patients could charge or replace batteries without the risk of pump failure.

Aortix is a first-in-class device that holds the promise of extending the lives and dramatically improving the lifestyles of millions of heart failure patients around the world. It represents a win for multiple stakeholders: the cardiologist gains a safe and effective treatment option where none currently exist; the hospital converts lengthy, money-losing intensive care visits to profitable outpatient procedures; the insurance company sees a reduction in payments due to improved patient health; and, most importantly, the patient receives low risk, minimally invasive treatment early enough in the progression of heart failure to truly alter its course. This device is not yet approved for use in humans. Procyrion’s first human trial is expected to begin in the first half of 2016.

Upon being told this winning device would be profiled in Medical Design Briefs, team leader Omar Benavides said: “We would just like to encourage every one of the engineers and designers reading this to keep relentlessly pursuing their goals and ideas. We live in a time when the barriers to innovation are lower than ever, when we can draw a part one day and have it in our hands the next. How incredible it is for us all to have this opportunity to improve people’s lives. Let’s make sure we use it!”

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