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| |  Laparoscopic Device Cleared By FDA For Less Invasive Tissue Removal SUNNYVALE, Calif., May 1, 1997 -- The U.S. Food and Drug Administration has given its marketing approval to the makers of the Diva(TM) device, a proprietary laparoscopic morcellator designed to enable gynecologists to remove large tissue masses from the abdomen through small incisions safely, quickly and inexpensively. "The Diva will be particularly useful for supracervical hysterectomy and laparoscopic myomectomy," commented George M. Savage, M.D., FemRx(TM), Inc. senior vice president of research and development. "It also has broad applications in other areas of gynecologic and general surgery. This is the first device to provide surgeons with high speed tissue morcellation that is safe and easy to use. Not only will it improve patient outcomes but it will also lower procedure costs." "Approximately 50% of all hysterectomies performed today should instead be OPERA(TM) (Out-Patient Endometrial Resection/Ablation) procedures," commented Dr. Arnold Kresch, associate clinical professor at Stanford University and member of the FemRx Scientific Advisory Board. "Patients undergoing OPERA receive definitive therapy but avoid the pain and suffering associated with hysterectomy. If a hysterectomy is necessary, then a supracerival hysterectomy is a less invasive procedure which maintains the integrity of the pelvic floor, speeds recovery and reduces long term complications such as incontinence, which affect many hysterectomy patients today." The Diva device will be sold by FemRx in a procedure pack that supplies all the tools required for supracervical hysterectomy. This product will be integrated into the FemRx Center of Excellence program enabling surgeons to access training, clinical programs, patient outreach and reimbursement support programs designed to successfully integrate the most advanced procedures and technology into their practice. Headquartered in Sunnyvale, Calif., FemRx, Inc. is developing innovative surgical systems for the diagnosis and treatment of gynecologic disorders. FemRx' proprietary OPERA STAR(TM) (Out-Patient Endometrial Resection/Ablation Specialized Tissue Aspirating Resectoscope) and Flo-Stat(TM) systems are used during OPERA(TM) (Out-Patient Endometrial Resection/Ablation) procedures -- surgical interventions that provide a minimally invasive alternative to hysterectomy for patients suffering from abnormal uterine bleeding (AUB).
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