Breast tumour localisation system receives FDA Approval

14th November 2017
Posted By : Enaie Azambuja
Breast tumour localisation system receives FDA Approval

Cianna Medical, Inc. has received FDA clearance of the SAVI SCOUT reflector for long term implant. The SAVI SCOUT reflector is an integral part of the SCOUT system for wire-free breast tumour localisation. This technology is the first and only non-radioactive implant used in wire-free localisation that can be implanted with no restrictions on the length of time the reflector can remain in the breast.

The newly acquired FDA clearance means that physicians will no longer be constrained by a maximum implant time, allowing them the flexibility to place SCOUT to mark a biopsy or lumpectomy site.

Using SCOUT, surgeons can precisely target the affected tissue using its 360˚ detection capability to pinpoint its location within ±1mm, which can mean more successful surgeries, optimised breast conservation strategies and enhanced outcomes for women.

The SCOUT FDA clearance for long term implant expands the number of women who can benefit from wire-free localisation technology, creating more options for physicians and their patients. In addition, because the SCOUT reflector will not interfere with MRI studies, patients are not restricted in the types of imaging modalities they may need.

The SCOUT reflector’s 4mm body size is smaller than a grain of rice and 100% non-radioactive. The reflector is completely passive until activated by the SCOUT guide. In addition, the patient cannot feel the reflector and can continue with all activities regardless of how long it is left in the breast.

“Achieving this milestone significantly advances Cianna Medical’s mission to reduce the burden breast cancer treatment places on women and their families. I applaud the vision of all our physicians and health systems who are leading the way in offering a new standard of care in breast tumour localisation,” said Jill Anderson, President and CEO of Cianna Medical.

“SCOUT has become the most precise and broadly applicable non-wire localising system in the industry and more than 170 leading medical centers across the United States have adopted SCOUT Radar Breast Localisation and Surgical Guidance System as an alternative to placing wires on the day of surgery.”

“Our health system has made wire-free radar localisation our new standard of care for breast tumour localisation,” said Nina Vincoff, MD, Chief of Breast Imaging at Northwell Health.

“Our patients have indicated high satisfaction with the procedure. This new FDA clearance will continue to enhance the patient experience by offering more options and flexibility for physicians to implant the reflector based on patient treatment needs.”

Northwell Health, New York State’s largest integrated health system, has collaborated with Cianna Medical to offer wire-free radar localisation to patients since July 2016.

The SCOUT radar localisation system will be exhibited at the Radiological Society of North America (RSNA) in Chicago, IL, November 26–December 1, 2017. Cianna Medical booth is located in North Hall B – Booth Number 6247.


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