November 15, 2006 Eight Studies Evaluating Cytyc's Novasure(R) System Presented at AAGL MeetingMARLBOROUGH, Mass., (Nov 15, 2006) - Cytyc Corporation today announced that a total of eight studies evaluating performance of the NovaSure(R) System for endometrial ablation were presented at the 33rd Annual Meeting of the American Association of Gynecologic Laparoscopists (AAGL) in Las Vegas. The studies covered a range of performance characteristics and patient populations. The studies included two evaluating the use of the NovaSure System in an in-office setting, and one presenting five-year follow-up data on the efficacy of the NovaSure System for the treatment of abnormal uterine bleeding using second generation endometrial ablation. David Kreuze, M.D., presented a study assessing the ability of performing the NovaSure Endometrial Ablation in-office under local anesthesia. The study included 30 patients with refractory menorrhagia. All patients were treated with NovaSure Endometrial Ablation with no endometrial pre-treatment of any kind. Patients were instructed to take a mild tranquilizer and an analgesic prior to arriving at the office. At the office a local anesthetic (para-cervical block) was administered prior to the procedure. The author reported that 29 of the 30 patients were treated successfully and 87 percent reported minimal or moderate discomfort. All treated patients were released within 15 minutes of procedure completion. Robert Southwick, M.D., and Amy VanEss, R.N., presented a similar study, which assessed the safety, tolerability, and efficacy of NovaSure Endometrial Ablation performed in-office with minimal anesthesia. The prospective study included 78 women with severe menorrhagia secondary to dysfunctional uterine bleeding (DUB). All patients underwent pre-procedure endometrial biopsy and hysteroscopy. The patients did not receive any drug or mechanical pre-treatment to thin the endometrium prior to the procedure. Patients were advised to take a mild anti-anxiety and an analgesic orally before arrival and were given a local anesthetic at the office prior to the ablation. NovaSure Endometrial Ablation was successfully performed in-office with local anesthetic on 94 percent of patients (73/78). Three patients were not eligible for ablation and the NovaSure procedure was successfully performed on two others in the operating room. Results for the 73 patients showed average pain scores similar to pain experienced during menses. The patients treated with NovaSure Endometrial Ablation had a mean satisfaction score of 4.79 on a scale where one is dissatisfied and five is extremely satisfied and 72 of 73 patients said they would recommend the procedure to a friend. A study by Bongers et al., from Maxima Medical Centre, in Veldhoven, The Netherlands, presented five-year follow-up data comparing the NovaSure System and ThermaChoice(R) balloon ablation for the treatment of pre-menopausal women with menorrhagia. The study included 126 patients randomized at a ratio of two to one, NovaSure System versus ThermaChoice. Five-year follow-up data was available for 80 percent of the NovaSure System arm and 72 percent of the ThermaChoice arm. Results showed that at five years post-treatment, hysterectomy was avoided in 91 percent of the patients treated with the NovaSure Endometrial Abalation System and 89 percent of patients treated with ThermaChoice. Amenorrhea rates were 68 percent in the NovaSure arm and 36 percent in the ThermaChoice balloon arm. The authors concluded that the NovaSure System is an effective and safe second-generation device, and yielded better amenorrhea and patient satisfaction rates when compared to ThermaChoice. "The studies presented at this meeting clearly demonstrate that use of the NovaSure Endometrial Ablation System in an office setting under local anesthesia is a viable alternative for many patients and their physicians," said Ellen Sheets, M.D., Cytyc's chief medical officer. "In addition, the five-year follow-up data presented at this meeting suggests that NovaSure provides a greater long term amenorrhea rate as compared to the balloon technology and validates the efficacy of NovaSure technology in avoiding costly and invasive hysterectomies for the treatment of menorrhagia." About Hologic
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