How a Tiny Breast Cancer Device Carries Big Value

FDA cleared Cianna Medical's Savi Scout reflector for breast cancer conservation surgery without restrictions on the length of time the implant can remain in the breast.

With all the uncertainty in today's healthcare system, the one thing everyone seems to agree on is that value-based care is here to stay. Cianna Medical understands that particularly well, and the company's latest FDA clearance is expected to add even more value to the continuum of care for breast cancer patients and their providers.

Cianna's Savi Scout reflector, which is 4mm in size (smaller than a grain of rice), can now be implanted in breast cancer patients without restrictions on the length of time that it can remain in the breast. The device is a non-radioactive implant used in wire-free localization. It is completely passive until activated by a special handpiece, which acts as the radar system, at the time of the procedure to locate the reflector. Before this clearance, the reflector was allowed to stay implanted for up to 30 days. Patients cannot feel the reflector while it is implanted and they can continue with all activities regardless of how long it is left in the breast, Cianna noted.

"We're replacing a 30-year-old technology called wire localization," CEO Jill Anderson told MD+DI Qmed. "In that technique, ladies would go into radiology the morning of their surgery and they would place a wire into the breast with the theory that the bottom of the wire would be at the tumor location and the proximal end of that wire would then be hanging from the breast. And then, when the ladies were in the OR, the surgeons could see the entry location, which may or may not relate linearly to where the tissue is that they need to remove and then they would use that wire to guide them down to the tissue that needed to be removed."

The wire localization technique is less than efficient because the radiology department, the surgery department, and the surgeon all had to correlate their schedules, which can cause delays and workflow problems, Anderson explained. 

"The way they usually accommodate that is the radiology department will need to block time in the morning and reserve that time in case there's a wire localization procedure that needs to be done," she said. "Then, if it happens that cases are canceled or there are no cases on that day, that blocked time goes unused, which is a real workflow issue for radiology."

Anderson said studies have shown that 30% of cases are delayed, which means patients are getting to the OR later than scheduled either because the radiology schedule was delayed, or there were more challenges getting the wire placed than anticipated, or for some other reason. "And it's estimated that the average delay in the OR is about 30 minutes per case," she said. "So one of the immediate advantages that hospitals find [with Scout] is that they can turn over their OR much more quickly."

Surgeons like the Savi Scout reflector because it is more precise, and they can find the target tissue with a plus-or-minus 1 mm of accuracy, Anderson said. "So for the surgeons, it makes it much easier for them to locate the tissue that needs to be removed. That can equate to better outcomes for ladies," she said.

Those improved outcomes are realized in one of two ways. If there is less tissue being removed because they can get to that target tissue in a better way, that impacts cosmesis. But also, between 20% to 60% of women who have a lumpectomy have to go back for a repeat surgery because of cancer left behind. According to Anderson, wire localization procedures are the number one cause of secondary surgeries. "It just simply isn't accurate or adequate for tumor localization, and there's no active guidance," she said.

Patients benefit from having a far less stressful surgery day than if they had to begin by going to radiology. They also have a reduced risk of needing a second procedure.

"So you take a look at all that value that's packed into this one little itty bitty reflector, it's amazing," Anderson said.

Now that there are no constraints on when the reflector can be implanted, the device can potentially be implanted at the time of biopsy, which eliminates the entire localization procedure and takes huge costs out of the system, Anderson said.

More than 170 centers have adopted Cianna's technology in just 20 months on the market, so the rapid adoption suggests that the value analysis committees are embracing the technology too. "Because they understand the importance of improving workflow efficiencies, the importance of outcomes, and the cost associated with doing secondary surgeries," Anderson said.

In fact, the company has a 99.9% approval rate by hospital value analysis committees, she noted.

"Technologies that are being developed really need to be able to address each of those three pillars of value-based care: workflow, outcomes, and satisfaction," Anderson said.

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