Houston—More than 12 million people in the United States and European Union have congestive heart failure, but there are only about 4,500 hearts available each year for transplant.
LVADs—left ventricular assist devices—have been used to help some of these patients, but installing them means cracking open patients’ chests in expensive open-heart surgery and a month-long recovery time. The devices are also not suited for small people or for those who are already frail. And in up to about 11 percent of those who receive them, the devices can cause strokes.
William Altman, CEO of Corinnova, says the Houston medtech company has developed a device called EpicHeart that avoids those issues. To further the device’s development, Corinnova says the company has received a $6.1 million investment from the Wellcome Trust in London to support more tests of the device.
“The difficulty in using LVADs is that you have to be strong, you can’t help end-stage patients,” he says. “We’re not trying to replace LVADs, but we give an alternative for people who can’t use those.”
Corinnova’s EpicHeart is a minimally invasive device that surrounds the heart with a plastic encased wire framework. The innermost of two chambers is filled with saline to conform to the shape of a patient’s heart and the outermost pumps air to gently squeeze the heart to increase its output. (Click here for an animation that illustrates how the device is implanted and works.) Altman says the recovery time for the implantation of Corinnova’s device is expected to be less than a week.
Corinnova’s technology was developed by John Criscione at Texas A&M University, who is also the company’s co-founder and chief technology officer. Founded in 2005, the company has so far raised about $8.5 million, including money from grants and angel investors. Altman joined Corinnova in 2009. The company has conducted large animal trials in sheep at the Texas Heart Institute in Houston and is currently working on doing final animal safety efficacy studies, Altman says. He expects tests of the device in humans could start next year.
Another Houston company aiming to “help the heart work better” is Procyrion, which is developing a circulatory support pump called Aortix. The device also says it serves as a crutch for the heart, helping to push blood through the circulatory system. Recently, Procyrion has tested its device in humans, in trials where patients were fitted with the pump while they had a percutaneous coronary intervention—having a stent inserted to open up blood vessels in the heart, according to a TMC News article on the company’s website. (Aortix was removed a few days after this procedure.) The company now plans patient trials that will enable Procyrion to apply for FDA approval.
Altman says the efforts to develop new types of cardiac assist devices point to the need of a device that can assist a wider range of heart failure patients. As many as four times the number of heart failure patients could receive treatment should EpicHeart reach the market, he adds.
“Only the strongest of heart failure patients can withstand” open-heart surgery for the implantation of an LVAD, Altman says. “That limits treatment only to the strongest of the sick.”