Managing blood loss is one of the biggest challenges in liver resection procedures that involve cutting out diseased tissue in liver cancer patients.
The resections can sometimes require blood transfusions of large amounts of blood, which is an expensive proposition for hospitals who have to store and manage the blood. So much blood loss is also traumatic for patients.
If blood loss can be reduced, it would dramatically alter the surgery landscape. That is the belief of one company that has licensed a technology developed at the University of Madison that aims to do precisely that.
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Medical Engineering Innovations (MEI) hopes that its new device with its blade-shaped electrode boasting a larger array, ability to coagulate large blood vessels and unique algorithms for delivering RF energy, will make liver resections less traumatic for patients and more efficient for physicians. The need for large amount of blood transfusions will also decline.
The company, which has developed a lab prototype, is hoping to raise some seed funding to the tune of $1 million by the end of the year, said Richard Schmidt, president and CEO, who joined the company in January. He expects that the product will be on the market in the first quarter of 2014.
What makes Schmidt confident about the Madison, Wisconsin-based company’s prospects? After all, in the seven years since the company was founded, MEI has only managed to do animal testing and develop a lab prototype.
Schmidt acknowledges that it’s a question that keeps popping up. It hasn’t helped that two of the inventors and co-founders of the technology have retired while some have also moved out of state. The company has survived on grants and founder investments
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But one of those very inventors who moved out of state and is now James R. Hines professor of surgery and chief of gastrointestinal and oncologic surgery at Northwestern University Feinberg School of Medicine. His experience with doing resections with current tools has made him believe even more in the potential for MEI’s product, the one he helped develop, Schmidt said.
Here’s why:
Most coagulation devices have a needle-shaped electrode with a small array. That requires the physician to insert the electrode and deliver the energy multiple times across the liver, which increases procedure times. Schmidt said MEI has a blade-shaped electrode with a large array.
“What we have done is that we have created a much larger array so that you can get across the entire liver in one shot,” he declared. “One competing device has a very small array. They can coagulate within one to two minutes, but the array needs to be replaced 10 to 15 times.”
By being able to insert, energize and coagulate the entire liver in one go, MEI’s SwiftBlade device reduces procedure times to three to six minutes from 10 to 30 minutes, Schmidt said.
The other advantage of the system also comes from the blade-shaped electrode. Because it has a larger surface area than needle-shaped electrodes, more power can be delivered across its surface area without charring the tissue that would come in contact with it.
Further, current devices on the market made by competitors like Medtronic, AngioDynamics and Covidien, cannot coagulate large blood vessels that can sometimes be up to 5 millimeters in diameter. They can only do up to 3 mm in diameter, Schmidt said. That complicates matters.
“When a physician runs into a blood vessel that is larger than [3 mm in diameter] either you get ineffective coagulation and excessive bleeding, which then has to be handled with a blood transfusion,” he said. “Or you have to stop what you are doing and go to an alternate tool with which you can do some sort of ligation, which increases the procedure time, increases the number of tools you have to use and also increases blood loss,” he said.
Because of the limitations of these devices, many liver cancer patients are not eligible for liver resections because their livers may already be weakened before the cancer took over and now cannot risk blood loss and transfusions. But the unfortunate reality is that the five-year survival rate for cancer patients who don’t receive a liver resection is under 1 percent, Schmidt explained.
“What we are trying to do is make the liver resection process a little less traumatic for the patient so that more people can be eligible for it,” he said.
