North American Scientific (NAS; Chatsworth, California) CEO Michael Cutrer said the company is developing a specific device for breast brachytherapy that will allow it to enter this developing $500 million market by year's end.
Cutrer said there are two methods for breast brachytherapy now. One involves placing catheters through about 15 to 20 needles that are placed in the breast, with radiation delivered twice a day for five days.
The other method, he said, involves a balloon catheter that is placed through a single incision. The balloon is expanded and the radioactive agent is delivered through a central lumen over five days directly to the tumor bed.
“What we're doing is kind of blending the two, and we have a multi-channel catheter that will conform to the shape and size of the tumor bed, and it's placed through a single incision,“ Cutrer told Medical Device Daily. “So, what that allows the physicians to do is either [take] their high-dose rate irradium source . . . and place it in closer contact to the tumor bed in multiple sites, which allows them to conform the dose of radiation more accurately or more uniquely to a given patient.“
Perhaps the greatest distinguishing feature is that the multi-channel catheter will allow physicians to use low-dose radiation sources. Those “sources“ would be the same brachytherapy seeds, or Prospera seeds, that the company sells to treat men with prostate cancer.
“[The seeds] would just be placed into the channels and left there for four to five days,“ Cutrer said. That allows for “dosing the tumor bed continuously with low-dose radiation,“ he said.
“Many physicians feel that is an improvement over the high-dose rate because with continuous dose and with our design, we're not compressing tissue, which occurs with the balloon,“ Cutrer added.
The “balloon“ procedure is one developed by once privately held Proxima Therapeutics (formerly Alpharetta, Georgia), a company acquired by Cytyc (Marlborough, Massachusetts) in March of last year (Medical Device Daily, March 9, 2005).
The other alternative with needles and catheters is a procedure favored by some radiation oncologists.
NAS has filed for patent protection and is completing design of its multi-channel catheter device that “can be easily placed“ by the physician following surgery and prior to initiation of radiation treatment, the company said. The new catheter device is designed to accommodate either high dose or low dose rate treatments.
NAS has submitted a 510(k) application to the FDA for a device that delivers a low-dose-rate treatment utilizing its Prospera brachytherapy seeds. Within 90 days, the company expects to file a second 510(k) application to market a similar device for the high dose rate procedure.
The company currently plans to launch its accelerated partial breast irradiation devices at the 48th annual meeting of the American Society of Therapeutic Radiology and Oncology (Fairfax, Virginia) in November.
“There were approximately 270,000 new cases of breast cancer diagnosed in the U.S. in 2005, according to the American Cancer Society ,“ Cutrer said. “When facing this diagnosis, they will generally undergo surgery and some form of follow-on treatment.“
He said studies have shown that women with early-stage cancer who chose a lumpectomy procedure combined with radiation have the same long-term survival rates as those that chose mastectomies.
“However, the current six-to-eight-week, whole breast irradiation treatment that most lumpectomy patients receive is very impractical for many women,“ Cutrer said. “It also is believed that many patients elect mastectomy for fear of irradiating the whole breast and surrounding healthy structures such as the heart, lungs and ribs.“
He added that “several studies of Partial Breast Irradiation patient groups have shown that treating only the resected area of the breast twice a day for five days results in low recurrence rates statistically equivalent to extended whole breast radiation treatment. We believe that a growing number of women are electing for this accelerated treatment option. We also believe that the features of our new device can lead to greater acceptance of this newer accelerated treatment approach.“