On the heels of Food and Drug Administration approval, a medical device that allows surgeons to remove liver tumors with minimal blood loss is facing its first series of tests in the United States.

"The first use of the device in America is a significant and exciting milestone as we continue to develop the potential of radiofrequency and microwave technologies for surgery," said Nagy Habib, ChM, a professor of Hepatobiliary Surgery at Imperial College in London and the inventor of the Habib 4X resection device.

Dehydrating Tissue Helps Block Blood Loss
The device uses high-energy radiofrequency waves generated through a handheld device made up of four electrodes. The electrodes are directed into liver tissue, and heat causes the tissue to dehydrate, resulting in a tight seal. "Once the tissue is sealed, the surgeon uses a conventional scalpel to resect [cut out] the unwanted tissue without bleeding," explained Habib, adding that the device also precludes the need for staples, glue, ties, and sutures.

"The liver is the second commonest site of cancer in the body," he said, "So, the potential of the Habib 4X is huge."

The concept behind the device was derived from the use of tumor ablation devices in surgical procedures that destroy malignant cells, but may leave some cells still intact. "The technique is effective, but it is difficult to know that all the cancerous cells have been destroyed. Leaving any alive runs the risk of the tumor spreading," said Habib. "I thought that if we used the same principles of heat to destroy cells, but combined in a surgical device that can cut out the tumor rather than leaving it, would make sense."

Surgical Blood Loss: A Major Challenge
In standard surgical procedures in which liver tumors are removed, patients can often lose up to ten pints of blood, according to Habib. In fact, experts have pointed out that significant blood loss is a major complication of surgery to remove liver tissue due to cancer, and often requires a blood transfusion.¹

Other common techniques used by surgeons to minimize blood loss include the use of a medication called aprotinin, a serine protease inhibitor that reduces injury to liver tissue during surgery, as well as techniques to minimize bloodflow into the liver during surgery.^1,2

However, Habib says his device prevents most blood loss, except for less than 50 milliliters (about 0.1 pint).

Debut Testing in the US
Habib struck a worldwide licensing deal with RITA Medical Systems, a California-based medical device company that focuses on cancer therapies, to market the Habib 4X. Following FDA approval, the device was successfully tested for the first time by doctors at the City of Hope National Medical Center in Duarte, California in early September.

The device has already undergone medical scrutiny in Europe, as well. According to Habib, since the resection device first began testing in late 2004, more than 100 patients have undergone liver cancer surgery, and there have been no significant postoperative complications. Additionally, the average hospital stay has been reduced from two weeks to eight days following surgery, he said. All patients who underwent surgery using the device were followed over a period of between two and 20 months, and there were no signs of tumor recurrence in any of these cases.

"Using the Habib 4X has made surgery safer for patients because it avoids the need for admission to the ICU, [as well as] the use of intraoperative blood transfusion, has reduced the incidence of bile leak, and has reduced the number of days spent in hospital recovering from surgery," Habib said. "I use it routinely on all my surgeries."

Reaction Has Been Positive
According to officials at RITA Medical Systems, European surgeons have expressed positive interest in the device, and the company believes the same will hold true here in the United States.

Said Joseph DeVivo, the company's President and CEO: "With our focus on cancer therapies, we expect the Habib 4X to be a strong addition to our product portfolio, and for it to be of interest to the surgery, oncology, and cancer communities, which include existing, as well as many potential new customers."

1. Joshi RM, Palep JH, Sayed S, Mehta S. Hepatic resection: An insight. Indian J Surg 2005;67:13-20. Available at: http://www.indianjsurg.com/article.asp?issn=0972-2068;year=2005;
volume=67;issue=1;spage=13;epage=20;aulast=Joshi. Accessed September 22, 2005.
2. Lentschener C, Roche K, Ozier Y. A review of aprotinin in orthotopic liver transplantation: can its harmful effects offset its beneficial effects? Anesth Analg 2005 May;100(5):1248-55.

John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include overseeing health news coverage for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.