Liver Cancer and the SwiftBladeTM System
Liver Cancer Information
- Among cancer deaths, liver cancer is the 3rd most common cause.
- Approximately 1,000,000 cases of liver cancer are diagnosed each year, world-wide.
- About 500,000 people die each year from liver cancer.
- There has been a three-fold increase in the incidence of primary liver cancer (hepatocellular carcinoma) in the US in the past decade.
- Liver resection (partial or complete removal of a lobe of the liver) is currently the preferred treatment for metastatic and primary liver tumors.
- It is estimated that there will be 22,000 liver resections and 10,000 liver tumor ablations in the US in 2016.
- 5-year survival rates following liver resection are between 27% and 43%, and are considerably lower for other types of treatment (e.g. chemo- and radiation therapy).
- Liver resection can result in blood loss of 0.6-1.3 liters.
- 28% to 47% of liver resection patients require blood transfusion
- Blood loss during liver resection is associated with:
– Decreased long-term survival
– Increased risk of perioperative
– Prolonged hospital stay
– Increased risk of infectious
- 5-year survival rate for untreated liver cancer is less than 1%
The SwiftBladeTM System
RF Ablation and Liver Resection devices:
MEI has developed the SwiftBlade™-R and SwiftBlade™-A technologies, which have been successfully used to perform liver resection and liver tissue ablation in live animal surgical tests.
The SwiftBlade™ system consists of a bipolar RF generator and a procedure-specific disposable blade set. The RF generator package includes switching electronics and the proprietary algorithm that monitors the electrical impedance of the tissue in order to provide feedback to the control and switching electronics, resulting in a uniform ablation zone and automatic power interruption upon completion of the procedure.
The blade set choices include a linear array for resecting across the organ and various diameter circumferential arrays for ablation of localized tumors.
The SwiftBlade™ system has been tested against other products and was found to provide leading edge performance due to:
- Blade-shaped electrodes instead of needles, which provide rapid heating and more uniform temperatures in the tissue volume
- Bipolar RF power, which eliminates the use of ground pads and associated possibility of skin burns
- Proprietary RF power switching algorithm, which continually measures tissue impedance and adjusts output power based on those measurements.
- Ability to coagulate blood vessels up to 5 mm in diameter across the entire array simultaneously
- Ablation arrays which do not penetrate the tumor, thereby minimizing the risk of tumor reseeding
FDA market clearance for these technologies will be sought under a 510(k) submission.
To Learn More
To learn more, or if you would like to help MEI provide liver cancer patients with a better alternative, please email MEI.