Abiomed (Danvers, MA) has announced the introduction of a synchronized minimally invasive implantable cardiac assist device at the American Heart Association Scientific Sessions in Orlando, FL. Developed to treat patients with chronic moderate heart failure, the Symphony improves coronary perfusion and cardiac output. The device is the first implantable cardiac assist device designed for heart recovery or remodeling, according to Abiomed. According to the company, the system can be implanted in a patient in roughly 30 minutes. The pump is intended on being explanted after extended support at home.
Medgadget had the chance to talk to Robert Dowling, MD, who helped develop the device, to hear what he had to say about it.
“Part of the beauty of the device is its simplicity,” Dr Dowling told Medgadget. “if I were talking to cardiologists about the device, I would say that we have a pump that we place with a minor operation. And I would say: ‘You know where you put pacemakers? That’s where I put this pump.'” After they are told that, they usually do a double take and say ‘really?'” Dowling says. “‘Yes, really'”, he tells them. “We just sew one graft to the subclavian artery. And after that, the pump’s implanted,” Dowling adds. “And then, usually by that time, you’ve got their attention.”
The pump is timed to an EKG so that it fills when the heart beats making it easier for the heart to beat. “The device decreases the work of the left ventricle and it provides after-load reduction,” Dowling explains. “When I explain [how the device works] to my buddies, I say it’s like if you are trying to bench press and you put a little bit too much on the bar and somebody comes up and kind of gives you a boost every time you lift it up,” he says.
“The other way it helps is while the heart is resting it ejects,” Dowling says. That helps the heart by giving it more blood flow but it also helps the entire body. “[In patients who would need this pump] there’s this imbalance between how much work the heart is doing and how much blood flow it’s getting.” In such cases, the heart is doing too much work and getting too little blood flow. “So, one of the really neat things about this pump is it addresses that ratio in both ways: it decreases the work and it increases blood flow,” Dowling says. “It not only helps the heart by increasing blood flow but it also helps the kidneys, liver, all the other organs by increasing blood flow to them. If someone’s heart is beating 100 times a minute, that would be putting out an extra three liters a minute,” he explains. “We get an advantage coming and going,” Dowling says. “We get an advantage when the blood goes into the pump and while the heart is resting, we get an advantage in improving the blood supply to the body.”
We asked Dowling about the market potential of the device and he said he had high hopes for its ability to help many patients. “Our feeling is, if somebody—and we hope that somebody is us—develops a device that can be put in with a simple operation and is simple for the patient to use and does not require long hospitalization and really help the heart, then I think that is going to end up being a disruptive technology. And we think it is this device. Now, I can’t tell you that is this device because we don’t have patient data yet. But that’s what we think.” The pump is also expected to be substantially more cost-effective than conventional implantable LVADs.
Dowling explained that he worked with a team years ago that laid out some basic goals for a “newer, kinder, gentler next-generation pump.” The guidelines for the device prescribed that it did not require a major operation, that it be easy to implant, be effective while the heart rests, and that it would improved patients’ quality of life. “This device meets all of those goals that we set at the beginning of this project about eight or nine years ago. So, I guess that’s why I seem super-excited about it.”
When developing the device, Dowling’s research group received more than $6 million in funding from the National Institutes of Health (NIH). “When you submit a grant to the NIH, one of the things they look for is that a problem with a major clinical need is addressed. The other thing they look for is the use of an innovative approach,” Dowling says. “Every time we submitted this grant, we got funded. We got great feedback.”
According to Abiomed, the first-in-man clinical trials involving the device are anticipated to be performed in early 2012.