Sicel Technologies (Raleigh, North Carolina) reported that it has received FDA 510(k) clearance for its Dose Verification System (DVS), a wireless implantable radiation sensor and reader designed to help radiation oncologists determine if the radiation they're administering has hit its target. The device also provides physicians with the knowledge of how much radiation has hit the target.
At this point, the DVS sensor is approved only for breast cancer, but the company said it expects to expand the indications for radiation treatment of other cancers.
The time is especially right for such a product, according to Michael Riddle, president and CEO of Sicel. "I think if you're going to perform highly targeted – what is now called image-guided radiotherapy – then this is the next step," he told Diagnostics & Imaging Week. "This provides you with actual dose information, and, as with a lot of technologies, I think you can either be ahead of the curve or behind it."
Riddle said that if one looks at "all the market information that's out there about radiation therapy, all of the big linear accelerator companies are selling image-guided radiotherapy and more conformal radiation therapy as the way to go."
The DVS, based on technology licensed from North Carolina State University (Raleigh), is about 20 millimeters long and 2 millimeters in diameter.
The device can be implanted at the time of lumpectomy if cancer is discovered during the procedure, so it doesn't require additional surgery. Riddle said that even if it had to be implanted at a later time, this could be accomplished through a local procedure insertion with an instrument similar to a biopsy needle.
There is no activity in the sensor once it is implanted until the time of the radiation therapy, he noted.
"It sits there quietly – it's not powered, it's nascent," Riddle said. "And then wi-fi radio frequency coupling from an outside antenna can interrogate it [following the radiation treatment]."
The physician will know what the predicted dose should have been, "and now, for the very first time, he can actually confirm that the dose he thought he was giving to the tumor is actually getting there," Riddle said.
"There's a lot of adverse events that can be generated from radiation," Riddle told D&IW. "Obviously, if you [target] anything with enough radiation, you can kill it. This radiation is obviously passing through normal tissue to hit the tumor and obviously exiting out of the other side. So, if you get more than just collateral damage, then there's a good opportunity of causing adverse events, and I think [those events] are fairly well documented."
Riddle said the company has had good response for the product from radiation oncologists and physicists, and Sicel is planning for their quick adoption of the technology. He estimates the cost of adding the sensor to be less than 10% of the cost of the radiation treatment itself.
Sicel is in the process of completing manufacturing up-fit for the DVS and to begin taking orders and shipping it in the third quarter.
Dr. Charles Scarantino, principal investigator for the DVS clinical trial, on which the 510(k) was granted, said, "Almost every cancer center has the equipment required to visualize the DVS sensor without the need to purchase additional capital equipment."
Scarantino added: "Today's highly conformal radiation therapy treatment options rely on knowing the exact location of the tumor to be treated. While there are several methods available to facilitate tumor localization, none provide actual dose information."
The company, which has 28 employees, was formed in 1999 to develop a miniaturized, implantable device using multiple sensors in a closed-loop telemetry system.
Sicel was launched based on Scarantino's working with a professor at North Carolina State University.
The company used a predicate device of just "routine surface dosimetry" to win the 510(k) clearance for the DVS, Riddle said.