Curon Medical Launches Secca® Clinical Patient Registry for Bowel Incontinence Treatment

FREMONT, Calif. -- Curon Medical, Inc. the manufacturer of the Secca system for the treatment of bowel incontinence (BI), announced the launch of its new Secca Clinical Patient Registry for Bowel Incontinence, an online program introduced in Dallas at this year’s annual meeting of the American Society for Colon and Rectal Surgeons (ASCRS).

The registry, which will be administered by an independent clinical research organization, has been developed for physicians to share information regarding clinical management and outcomes related to treating BI using the Secca procedure.

Dr. Anthony Senagore, Staff Surgeon, Department of Colorectal Surgery, Cleveland Clinic Foundation stated, “We congratulate Curon Medical on taking this very responsible and proactive step in the introduction of its Secca Registry. This clearly shows that the Company has great confidence in the clinical outcomes that this procedure can produce. Making this information available through a professionally managed clinical research organization will help to provide surgeons using the Secca procedure with the very latest information available regarding procedural outcomes, and the confidence of knowing that the patients’ rights to confidentiality are being protected.”

Data is submitted to the registry by physicians and patients prior to undergoing the Secca procedure, then again at one, three, six, 12, 24 and 36 months after treatment. Physicians will be able to access the collated data over time to more thoroughly advise their patients about the Secca procedure.

“Bowel Incontinence has a severe negative impact on a patient’s lifestyle and overall quality of life,” said Larry C. Heaton II, President and Chief Executive Officer of Curon Medical. “The minimally-invasive outpatient Secca procedure provides an effective alternative for the treatment of BI that bridges the gap between more conservative therapies and significantly more aggressive surgical interventions. Several clinical studies to date have shown that the Secca procedure’s delivery of temperature-controlled RF energy to the anal canal can have a significant beneficial therapeutic effect on patients’ BI symptoms without precluding future treatment options. We are proud to facilitate the Secca Clinical Patient Registry for Bowel Incontinence, in addition to other supported clinical research, to further the education of clinicians about this minimally-invasive outpatient approach to treating BI,” concluded Mr. Heaton.

“By supporting the work of dedicated physicians researching an alternative to simply living with debilitating bowel incontinence, we are helping to develop a substantial body of clinical evidence of the safety, efficacy and durability of the Secca procedure,” said David W.J. Smith, Senior Vice President of Sales & Marketing.

“A multi-center prospective randomized double-blinded sham-controlled study for Secca is nearing completion with 95 of the proposed 110 patients treated, and we expect enrollment of the study to be complete by the end of July. This study builds upon the work of two previously published studies that demonstrated the procedure’s safety, efficacy and durability,” added Mr. Smith.

About The Secca System

The Secca System provides physicians with devices to perform a minimally invasive outpatient procedure for the treatment of Bowel Incontinence in patients who have failed more conservative therapy such as diet modification and biofeedback. The Secca System utilizes the same technology and treatment concepts as the Stretta® System. Using the Curon Control Module and the Company’s Secca disposable handpiece, physicians deliver radiofrequency energy into the muscle of the anal sphincter to improve its barrier function.

Source: Curon Medical

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