Sanarus Inc., a developer of minimally invasive diagnostic and treatment tools for breast disease, announced today that twelve-month follow-up data from a peer-reviewed, prospective multicenter study demonstrates that cryoablation is a preferred first-line treatment for breast fibroadenoma for women who do not want to undergo open surgery.
Cryoablation is a minimally invasive procedure in which a tumor is frozen while still in the body and is not surgically removed. Cryoablation has been successfully used in thousands of cases for the treatment of many diseases including skin, prostate, kidney and renal cancer.
The study, published in the June 2004 edition of the Journal of the American College of Surgeons, showed a median volume reduction of 89%, 12 months following cryoablation treatment of 57 breast fibroadenomas that had an average initial size of 2.1 cm. For those with a tumor whose initial size was less than 2.5 cm, the median volume reduction was 95% and 86% were non-palpable at 12 months. Patient satisfaction was reported to be 91%. The Sanarus Visica(TM) Treatment System was used to treat patients at several centers including the University of Washington, Wayne State University, Rush Presbyterian University and Cornell.
An estimated 520,000 fibroadenomas are diagnosed annually in the United States. The majority of women diagnosed as having a breast fibroadenoma choose to have it surgically removed. This may result in scarring at the incision site, dimpling of the breast from the removal of the tumor or damage to the breast's duct system. As a minimally invasive alternative, cryoablation can be performed in the comfort of a doctor's office, conserves breast tissue, and visibly reduces scarring of the patient's breast. The fibroadenoma is "quick-frozen," killing the tumor cells and causing the tumor to progressively shrink and disappear.
The study also demonstrated that no adverse effects were noted on any of the 12-month post-procedural mammograms. Therefore, undergoing cryoablation treatment should not influence future mammogram interpretation. In contrast however, open surgical excision may leave undesirable mammographic changes up to 50% of the time.
Cary S. Kaufman, M.D., FACS, President of the National Consortium of Breast Centers & faculty at the University of Washington was lead author of the study.
"Cryoablation is an effective and safe treatment for benign breast fibroadenomas," Kaufman said. "There is no incision but only a small puncture site to introduce the Visica probe, similar to a needle biopsy. The ice is inherently anesthetic in nature, allowing it to be performed completely in the doctor's office. No sedation or operating room is required and the need for prescription pain killers is rare. This allows the vast majority of patients to return to normal activity the very next day. The complication rate is low, patients recover very rapidly, and there is no or minimal scarring and excellent cosmesis. Cryoablation should be considered a preferred option in patients desiring treatment for breast fibroadenomas without open surgery."
John Rush, President and CEO of Sanarus, said the new clinical data continues to demonstrate that cryoablation is a viable, and often times preferable option, for the treatment of benign breast disease. "Physicians are looking for more effective ways to treat breast fibroadenomas," said Rush. "Young women with fibroadenomas are often caught between wanting them out and not wanting to undergo surgery with a resulting scar. Cryoablation gives them a great advantage which is easy, safe and cosmetically acceptable."