Cianna Medical said today it won additional FDA 510(k) clearance for its Savi Scout radar localization breast cancer device, now cleared to be placed at the lumpectomy site up to 30 days prior to surgical removal.
Aliso Viejo, Calif.-based Cianna’s Savi Scout is designed to produce audible and visual indicators surgeons can use to tag cancerous tissue during lumpectomy and biopsy procedures.
The surgeon uses a hand piece that emits infrared light and electromagnetic waves to locate a reflector placed in target tissue as long as a week before surgery. After reaching the surgical bulls-eye, the surgeon takes out the target tissue and the reflector, according to the company. No radiation is involved. It is designed for breast conservation surgery, where surgeons remove all detectable cancer cells.
“The new clearance enabling reflector placement up to 30 days before surgery provides us even more flexibility with scheduling. As an early adopter and ongoing user of Scout, I’ve found the technology to be highly intuitive, easy to implement and a significant improvement over wire localization in terms of patient experience. Importantly, use of Scout also supports greater efficiency in the hospital with less wait time for both patients and physicians,” Dr. Charles Cox said in a press release.
Data from a recent study of the device published in the July issue of the journal Annals of Surgical Oncology indicated a 100% surgical success rate and lower repeat surgery rates when compared to using wire localization, Cianna Medical said. Targeted lesions and reflectors were reported to be successfully removed without any observed reflector migration, the company said.
“Extending the timeframe between tumor localization and surgical intervention has the potential to improve scheduling flexibility for patients, physicians and health systems, further supporting the use of radar as a desirable platform technology for tumor localization. Scout is a novel technology, requiring no radiation or invasive wires, that has demonstrated the potential to drive value by reducing costs and improving patient outcomes,” CEO & prez Jill Anderson said in a prepared statement.
Last month, Cianna Medical said it raised $8 million for its Savi Scout breast cancer device, including a $4 million debt round from GE Capital and another $4 million equity round from existing backers.
Cianna said the investors in its latest funding round included Novo Ventures, Fog City Fund, Saints Capital and Emergent Medical Partners. Proceeds from the round are earmarked for Savi Scout’s national launch, the company said.
The device won 510(k) clearance from the FDA in December 2014.