An entrepreneur, an engineer and a doctor walked into a lab more than four years ago and created a medical device that could help millions of heart failure patients who cannot be helped by medication alone.<\/p>\n
Aortix is a catheter-deployed heart pump that provides circulatory support without surgery. Procyrion, the company born in the Texas Medical Center that created Aortix, recently completed a successful trial of the device in six humans who were receiving stents.<\/p>\n
The pump was implanted successfully in patients for a few days to reduce the workload of the heart.<\/p>\n
About three inches long and thinner than a No. 2 pencil, the pump can\u00a0move approximately as much blood\u00a0as a native heart\u2014about six liters per minute, according to Benjamin Hertzog, Ph.D., president and CEO of Procyrion.<\/p>\n
The removable pump\u2019s concept was developed by Reynolds Delgado III, M.D., founder and chief medical officer of Procyrion and medical director of mechanical assist devices in heart failure for the Texas Heart Institute and Baylor St. Luke\u2019s Medical Center.<\/p>\n
\u201cOriginally, bypass surgery was the only way to treat coronary disease, then stents came along, followed by cardiologists and cath labs,\u201d Delgado said. \u201cInstead of replacing the valve by opening the chest and putting\u00a0the patients on a heart-lung machine, now you can do it with transcatheter aortic valve replacement and a\u00a0cath lab.\u201d<\/p>\n
Delgado\u2019s idea was to place a small pump in the body, downstream of the heart, so it would not interfere with the failing heart and would also reduce some of the work pumping blood that the failing heart was struggling to do.<\/p>\n
The Aortix pump takes about\u00a010 minutes to implant into the descending thoracic aorta through the femoral artery in the groin. When in place,\u00a0little anchors that look like slim, metal fingers spring out and hold the device in the aorta.<\/p>\n
“There is an impeller in there that spins, so it pumps blood in from the top, and out of the bottom,\u201d Hertzog said. \u201cThe blood comes out in these little high-velocity jets pointed downstream, and it\u2019s those little jets that transfer energy to the native blood. So, it\u2019s like the lazy river you take your kids to\u2014that whole body of water is moved by these little bitty jets of water on the side.\u201d<\/p>\n
Moving the blood in this manner is known as fluid entrainment, a process also used in industries such as fracking. Aortix represents the first time this process has been applied to the human body, Delgado said.<\/p>\n
Heart failure is a progressive disease, which means that people experience different levels of failure. There are\u00a06 million people in the U.S. with heart failure, Hertzog said, but few transplants are done because few organs are available. And transplants are risky and expensive. A heart transplant and one year of care can cost close to\u00a0$1 million per patient, according to some estimates.<\/p>\n
That\u2019s why left ventricular assist devices (LVADs) and heart pumps, some of which were invented in the medical center, are being utilized. But implanting these devices is invasive surgery, Hertzog said, and reserved for those who are the sickest, because it is also risky and expensive\u2014more than $700,000 for implantation and therapy, according to studies.<\/p>\n
Procyrion is going after 2 million\u00a0of the 6 million patients with heart disease\u2014those who need more than medication to treat their heart problems yet are not sick enough to need\u00a0LVAD surgery.<\/p>\n
\u201cIf we can get to those patients before you need to crack their chest, maybe we can turn around their heart failure and prevent them from ever needing that,\u201d Hertzog said. \u201cThere\u2019s never been a device that can treat those patients. … We can put this tool in the hands of the cardiologist, and all of a sudden, you have a device that\u2019s low-risk, low-cost. It\u2019s a simple procedure, and now we can get to those patients.\u201d<\/p>\n
Procyrion\u2019s plan isn\u2019t to replace the LVAD and BiVACOR artificial heart, which Delgado\u2019s boss at the Texas Heart Institute, O.H. \u201cBud\u201d Frazier, M.D., is refining, but instead to expand heart care into a different area.<\/p>\n
\u201cWe will decrease the need for transplants, and that\u2019s good because there are only 2,000 donors available yearly,\u201d Delgado said.<\/p>\n
Aortix is designed to do some of the work the heart would normally do.<\/p>\n
\u201cHeart failure develops one heartbeat at a time, over months and years,\u201d said Jace Heuring, Ph.D., chief scientific officer at Procyrion. \u201cThis device would help it resolve the same way, one heartbeat at a time.\u201d<\/p>\n
Patients with heart failure typically end up in the hospital, short of breath and retaining fluid. That\u2019s because when the heart weakens, the kidneys don\u2019t get enough blood to do the job they need to do. The fluid weeps into the lungs and leaves patients unable to breathe, Hertzog said.<\/p>\n
During the human trials for Aortix, patients were fitted with the pump, while undergoing a percutaneous coronary intervention\u2014having a stent inserted to open up blood vessels in the heart. Aortix was put in first, reducing the workload of the heart, then the stent was put in and Aortix removed a few days later.<\/p>\n
\u201cOur pump was in periprocedurally, while they were placing the stent, and we had a perfect safety record,\u201d Hertzog said. \u201cAll the patients did great. We were able to show that we reduced the workload of the heart, we increased blood flow and we got the kidneys working in these patients.\u201d<\/p>\n
Procyrion\u2019s next steps include performing trials in patients with acutely decompensated heart failure; Aortix would be left in for up to seven days. Hertzog expects that to begin next year. If the trial goes well, a following trial is expected to move Aortix toward U.S. Food and Drug Administration approval, a pivotal step for mainstream use of the product.<\/p>\n
Procyrion recently kicked off its third round of funding and is looking to raise $25 million to carry the company through its first approval. There is interest in what Procyrion is doing, Hertzog said, and Aortix has already gained attention from a major medical device company.<\/p>\n
\u201cWhen we put this device in, it does some of the workload that the heart would have to do otherwise,\u201d he said. \u201cThe heart gets to rest. It gets stronger and then we imagine taking this out, and hopefully, it would change the trajectory of the disease for that patient. Hopefully, they never need a device again. They never need a transplant.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"
An entrepreneur, an engineer and a doctor walked into a lab more than four years ago and created a medical device that could help millions of heart failure patients who cannot be helped by medication alone. Aortix is a catheter-deployed heart pump that provides circulatory support without surgery. Procyrion, the company born in the Texas […]<\/p>\n","protected":false},"author":1,"featured_media":10451,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":"","_links_to":"","_links_to_target":""},"categories":[1],"tags":[211,451,397,738,56,1458],"yoast_head":"\n