Secca therapy is an outpatient procedure that takes approximately 45 minutes. It is performed in an endoscopy suite or ambulatory surgery unit, with the patient under general anesthesia (GA) or conscious sedation. During the procedure, RF at a frequency of 465 kHz enters the anal muscle tissue via an electrode, causing water molecules in the adjacent tissue to vibrate at the molecular level, generating heat.

As a result, multiple small tissue contractions are formed, and this causes the significant restoration of function to the anal sphincter. The delivery of RF energy is controlled using temperature feedback via temperature sensors both in the needle electrode and at the base of the needle in the Secca catheter. A control module regulates the four-channel RF energy generator via constant monitoring of temperature and impedance, enabling precise energy delivery, and an interactive graphics screen displays real-time progress. RF power is delivered at a level needed to achieve--but not exceed--the target temperature of 85 ^oC. A disposable handpiece is used for direct visualization and device positioning, and integrated ports deliver chilled water to the mucosa while deeper tissue is treated. Secca therapy was developed by Mederi Therapeutics (Greenwich, CT, USA).

“This innovative treatment bridges the gap between often unsuccessful conservative measures, such as diet modification and biofeedback, and expensive and disfiguring surgical treatment,” said Will Rutan, CEO of Mederi. “The effect of bowel incontinence on quality of life is devastating, so the overwhelmingly positive response to the release of the Secca system is not surprising.”

Patients can return home approximately one to two hours after the procedure and typically resume normal activities within several days. In clinical trials, as many as 8 out of 10 patients had a positive clinical response to the therapy and showed significant improvement in quality of life scores. Additionally, recent clinical studies have shown symptom relief lasting as long as five years.

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Mederi Therapeutics