Stretta(R) Procedure Effective
Thursday October 16, 2003
Press Release:
Data presented at a American College of Gastroenterology meeting showed long-term effectiveness of the Stretta(R) Procedure.
Press Release
Source: Curon Medical, Inc.
FREMONT, Calif., Oct. 16 /PRNewswire-FirstCall/ -- Curon Medical, Inc. (Nasdaq: CURN - News) announced today the presentation of data at the Annual Meeting of the American College of Gastroenterology, which ended yesterday in Baltimore, showing the long-term durability and effectiveness of the Stretta procedure for the treatment of gastroesophageal reflux disease (GERD).
Alvaro Reymunde, M.D., and colleagues, Ponce Gastroenterology Research, Ponce, Puerto Rico, presented long-term follow-up data on 50 patients who had been monitored for up to three years. The data showed that of the 86 percent of patients who experienced symptom control, (84 percent with control of symptoms within two months, and two percent with symptom control within 12 months), 81 percent were still symptom free for up to three years following their procedure (range 2.1 - 3.0 years, mean 31.7 months). It also showed that most of the patients that did experience recurrence indicated a much lower degree of symptom severity than before the procedure, and none reported any long-term complications.
Dr. Reymunde remarked, "The Stretta procedure is a safe and well tolerated procedure for the treatment of GERD. It is superior to drug-induced symptom control in a significant number of cases. We have shown the long-term efficacy of the procedure, evidenced by 81 percent persistence of heartburn symptom control for up to three years after the procedure."
"This data represents our earliest patients," commented Nilda Santiago, M.D. "As our one and two year patients move to the three year follow-up, due to our refinement in our protocol since inception, we may expect to see an even higher degree of symptom free outcomes."
George Triadafilopoulos, M.D., Professor of Medicine, Stanford University School of Medicine, a leader within the Gastroenterology community in the study of GERD and other esophageal disorders, and an early investigator of the Stretta procedure commented, "Dr. Reymunde's work is consistent with the results that we have seen elsewhere with the Stretta procedure. Since we started performing the procedure in 1999 we have witnessed the durability of this technique for controlling the symptoms of reflux disease. The Stretta procedure is an important tool in our armamentarium of methods for treating patients with GERD, particularly those who are intolerant of, or partially responsive to PPI therapy and are exploring other options, such as surgery."
Curon Medical's President and Chief Executive Officer, Larry C. Heaton II, said, "As an early adopter of the Stretta procedure in clinical practice, Dr. Reymunde is now in position to report on its long-term effectiveness in the clinical practice setting. As longer-term follow-up data emerges, we continue to be encouraged with the durability of the Stretta procedure. Various peer-reviewed clinical studies have previously reported the effectiveness of the Stretta procedure for patients suffering from chronic heartburn. The randomized sham controlled study published in Gastroenterology last month showed that the therapeutic benefit was not due to a placebo effect. The article by William Richards, M.D., of Vanderbilt University Medical Center, published in the Annals of Surgery earlier this year, reported that the Stretta procedure compares favorably with anti-reflux surgery, and a new article in the October issue of Gastrointestinal Endoscopy provides data showing that the Stretta procedure provides an economic benefit for those patients taking two or more proton pump inhibitors daily. The Registry of 558 patients presented by Dr. Herbert Wolfsen, of Mayo Clinic, Jacksonville, published in the Journal of Laparoendoscopic & Advanced Surgical Techniques earlier this year, demonstrated that the Stretta procedure is safe and effective in the clinical practice setting across the United States, with 90 percent of patients indicating that they would recommend the procedure to a friend suffering from GERD, and Dr. Reymunde's data provides evidence that the benefits are sustained over time. The aggregation of this data presents the Stretta procedure as safe, efficacious, durable and cost effective for those patients who either cannot tolerate, or fail to achieve adequate symptom control from, medical therapy."
About Curon Medical, Inc.
Curon Medical, Inc. develops, manufactures and markets innovative proprietary products for the treatment of gastrointestinal disorders. The Company's products and products under development consist of radiofrequency generators and single use disposable devices. Its first product, the Stretta System, received U.S. Food and Drug Administration clearance in April 2000 for the treatment of gastroesophageal reflux disease, commonly referred to as GERD. The Company's second product, the Secca System for the treatment of fecal incontinence, received clearance from the FDA in March 2002. For more information, please visit the Company's website at http://www.curonmedical.com.
About The Strettaź System
Curon's proprietary Stretta System provides physicians with the tools to perform a minimally invasive, outpatient endoscopic procedure for the treatment of GERD. The Stretta System consists of the Stretta Catheter, a disposable, flexible catheter and the Curon Control Module. Using the Stretta System, the physician delivers temperature-controlled radiofrequency energy to create thermal lesions in the muscle of the lower esophageal sphincter (LES). The tissue response to radiofrequency delivery alters LES function, which results in statistically significant improvements in GERD symptom scores, reduction in acid exposure and reduction in anti-secretory medication requirement.
Data presented at a American College of Gastroenterology meeting showed long-term effectiveness of the Stretta(R) Procedure.
Press Release
Source: Curon Medical, Inc.
FREMONT, Calif., Oct. 16 /PRNewswire-FirstCall/ -- Curon Medical, Inc. (Nasdaq: CURN - News) announced today the presentation of data at the Annual Meeting of the American College of Gastroenterology, which ended yesterday in Baltimore, showing the long-term durability and effectiveness of the Stretta procedure for the treatment of gastroesophageal reflux disease (GERD).
Alvaro Reymunde, M.D., and colleagues, Ponce Gastroenterology Research, Ponce, Puerto Rico, presented long-term follow-up data on 50 patients who had been monitored for up to three years. The data showed that of the 86 percent of patients who experienced symptom control, (84 percent with control of symptoms within two months, and two percent with symptom control within 12 months), 81 percent were still symptom free for up to three years following their procedure (range 2.1 - 3.0 years, mean 31.7 months). It also showed that most of the patients that did experience recurrence indicated a much lower degree of symptom severity than before the procedure, and none reported any long-term complications.
Dr. Reymunde remarked, "The Stretta procedure is a safe and well tolerated procedure for the treatment of GERD. It is superior to drug-induced symptom control in a significant number of cases. We have shown the long-term efficacy of the procedure, evidenced by 81 percent persistence of heartburn symptom control for up to three years after the procedure."
"This data represents our earliest patients," commented Nilda Santiago, M.D. "As our one and two year patients move to the three year follow-up, due to our refinement in our protocol since inception, we may expect to see an even higher degree of symptom free outcomes."
George Triadafilopoulos, M.D., Professor of Medicine, Stanford University School of Medicine, a leader within the Gastroenterology community in the study of GERD and other esophageal disorders, and an early investigator of the Stretta procedure commented, "Dr. Reymunde's work is consistent with the results that we have seen elsewhere with the Stretta procedure. Since we started performing the procedure in 1999 we have witnessed the durability of this technique for controlling the symptoms of reflux disease. The Stretta procedure is an important tool in our armamentarium of methods for treating patients with GERD, particularly those who are intolerant of, or partially responsive to PPI therapy and are exploring other options, such as surgery."
Curon Medical's President and Chief Executive Officer, Larry C. Heaton II, said, "As an early adopter of the Stretta procedure in clinical practice, Dr. Reymunde is now in position to report on its long-term effectiveness in the clinical practice setting. As longer-term follow-up data emerges, we continue to be encouraged with the durability of the Stretta procedure. Various peer-reviewed clinical studies have previously reported the effectiveness of the Stretta procedure for patients suffering from chronic heartburn. The randomized sham controlled study published in Gastroenterology last month showed that the therapeutic benefit was not due to a placebo effect. The article by William Richards, M.D., of Vanderbilt University Medical Center, published in the Annals of Surgery earlier this year, reported that the Stretta procedure compares favorably with anti-reflux surgery, and a new article in the October issue of Gastrointestinal Endoscopy provides data showing that the Stretta procedure provides an economic benefit for those patients taking two or more proton pump inhibitors daily. The Registry of 558 patients presented by Dr. Herbert Wolfsen, of Mayo Clinic, Jacksonville, published in the Journal of Laparoendoscopic & Advanced Surgical Techniques earlier this year, demonstrated that the Stretta procedure is safe and effective in the clinical practice setting across the United States, with 90 percent of patients indicating that they would recommend the procedure to a friend suffering from GERD, and Dr. Reymunde's data provides evidence that the benefits are sustained over time. The aggregation of this data presents the Stretta procedure as safe, efficacious, durable and cost effective for those patients who either cannot tolerate, or fail to achieve adequate symptom control from, medical therapy."
About Curon Medical, Inc.
Curon Medical, Inc. develops, manufactures and markets innovative proprietary products for the treatment of gastrointestinal disorders. The Company's products and products under development consist of radiofrequency generators and single use disposable devices. Its first product, the Stretta System, received U.S. Food and Drug Administration clearance in April 2000 for the treatment of gastroesophageal reflux disease, commonly referred to as GERD. The Company's second product, the Secca System for the treatment of fecal incontinence, received clearance from the FDA in March 2002. For more information, please visit the Company's website at http://www.curonmedical.com.
About The Strettaź System
Curon's proprietary Stretta System provides physicians with the tools to perform a minimally invasive, outpatient endoscopic procedure for the treatment of GERD. The Stretta System consists of the Stretta Catheter, a disposable, flexible catheter and the Curon Control Module. Using the Stretta System, the physician delivers temperature-controlled radiofrequency energy to create thermal lesions in the muscle of the lower esophageal sphincter (LES). The tissue response to radiofrequency delivery alters LES function, which results in statistically significant improvements in GERD symptom scores, reduction in acid exposure and reduction in anti-secretory medication requirement.
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