When physicians cut into a breast to draw a biopsy or excise a lump, it’s a bit of a guessing game of what’s where. The standard of presurgical tumor scouting, called wire localization, is a pretty decent – if dated – technique. SoCal device company Cianna Medical has built a way to one-up it, with a system meant to improve the acuity of tumor location and reduce the incidence of repeated surgeries.
Cianna’s new device, called the SAVI Scout surgical guidance system, got FDA clearance in December, and Cianna plans to bring this to market in the second quarter of 2015, CEO Jill Anderson said.
Wire localization allows docs to guide a wire, during mammography, that points to the abnormal tissue. Patients then head straight from radiology to surgery. But since the wire just serves as an arrow, the margins of affected tissue are difficult to gauge under the knife. This, about a quarter of the time, means repeated surgeries.
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“The standard technology now is pretty inadequate, but surgeons have been dealing with it for 20 years,” Anderson said. “It’s a universally understood problem.”
Th SAVI Scout, on the other hand, uses electromagnetic waves to detect a reflector, inserted in the target tissue up to a week before the surgery. Here’s how Cianna says it works:
During the procedure, the surgeon then uses the SAVI Scout handpiece, which emits infrared light and electromagnetic waves, to locate the reflector and plan the incision. The surgeon then removes the reflector and the target tissue.
Here’s what’s key: A handpiece can be used with retractors so, as the dissection proceeds, we receive immediate, real-time guidance for the lumpectomy, Pat Whitworth of the Nashville Breast Center said of the device. He added that the device eliminates the need to stop for intraoperative ultrasound; imaging only has to occur before and after the resection.
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A 24-patient pilot study of the device has thus far showed “100 percent success” in tumor excision; it’s ongoing at the University of South Florida College of Medicine and the Nashville Breast Center.
It’ll be interesting, of course, to see how reimbursement for such a device works out. While Anderson says it unequivocally adds to standard of care, payors still seem to favor the pretty good over best-in-class treatment methods.
Cianna Medical was founded in 2007, but the team actually began to work together in 2001 at a different company – BioLucent – which developed breast cushions to make mammography more comfortable and accurate. After BioLucent was bought out by Hologic for $70 million up front (and then some), staffers pivoted and formed Cianna, to develop SAVI brachytherapy.
This tech provides localized radiation dosing for breast cancers, shaving toxicity considerably – and treatment time down from several weeks to just one, Anderson said. (It should be noted that some studies have found that brachytherapy may actually have worse clinical outcomes than whole-breast radiation in older women. Cianna also put out a study on its relative longterm efficacy.) In any case, it’s been used in more than 20,000 breast cancer patients since its approval.