Peter,
This isn't quite what you were looking for. Digestive Disease Week is a couple of months away (I'll see if the abstracts are available yet, but I doubt it.) Nevertheless, it might give an early indication. The stock is up a bit on a tough day.
>> Gastrointest Endosc 2002 Feb;55(2):149-56
The Stretta procedure for the treatment of GERD: 6 and 12 month follow-up of the U.S. open label trial.
Triadafilopoulos G, DiBaise JK, Nostrant TT, Stollman NH, Anderson PK, Wolfe MM, Rothstein RI, Wo JM, Corley DA, Patti MG, Antignano LV, Goff JS, Edmundowicz SA, Castell DO, Rabine JC, Kim MS, Utley DS.
Gastroenterology and Otolaryngology-Head and Neck Surgery Sections, VA Palo Alto Health Care System, Palo Alto, CA 94304, USA.
BACKGROUND: This multicenter prospective study investigated the longer-term (12 month) safety and efficacy of radiofrequency energy delivery for the treatment of GERD. METHODS: A prospective study was conducted of 118 patients with chronic heartburn and/or regurgitation who required antisecretory medication daily and had demonstrated pathologic esophageal acid exposure, a sliding hiatal hernia (<or=2 cm), and esophagitis (<or= grade 2). RF energy was delivered with the Stretta catheter and thermocouple-controlled generator to create thermal lesions below the mucosa at the gastroesophageal junction. GERD symptom scores, quality of life (SF-36), and medication use were assessed at 0, 1, 4, 6, and 12 months; esophageal acid exposure, motility, and endoscopy were assessed at 0 and 6 months. RESULTS: Seventy-two men and 46 women were treated. At 12 months, 94 patients were available for follow-up. There were improvements after 12 months in the median heartburn score (4 to 1, p = 0.0001), GERD score (27 to 9, p = 0.0001), satisfaction (1 to 4, p = 0.0001), mental SF-36 (46.3 to 55.4, p < 0.0001), and physical SF-36 (40.9 to 53.1, p = 0.0001); proton pump inhibitor requirement fell from 88.1% to 30% of patients. Esophageal acid exposure improved significantly (10.2% to 6.4%, p = 0.0001). There were 10 (8.6%) complications, none of which required therapeutic intervention. CONCLUSION: The Stretta procedure significantly improves GERD symptoms, quality of life, and esophageal acid exposure and eliminates the need for antisecretory medication in the majority of patients at 12 months.<<
>>SUNNYVALE, Calif., March 20 /PRNewswire-FirstCall/ -- Curon Medical, Inc. (Nasdaq: CURN - news) today announced the presentation of the results of a U.S. clinical study illustrating positive outcomes in patients who have undergone the Company's minimally invasive, endoscopic Stretta® procedure for the treatment of gastroesophageal reflux disease (GERD). The study was conducted by William O. Richards, M.D., Professor of Surgery and Director of Laparoendoscopic Surgery at Vanderbilt University. Approximately 14 million U.S. adults annually require medical intervention to control the symptoms of GERD -- also known as gastroesophageal reflux disease.
Results Show Statistically Significant Improvement in Patient Symptoms The study was selected for presentation in the plenary scientific session at the combined 8th World Congress of Surgery and the Society of American Gastrointestinal Endoscopic Surgeons Meeting held in New York City last week. Specifically, Dr. Richards presented the results of 41 patients after the Stretta procedure. At baseline, nearly all patients had symptoms of GERD that were severe enough to require at least twice daily proton pump inhibitor (PPI) medication to minimize the symptoms. The study demonstrated that esophageal acid exposure and symptoms of heartburn and regurgitation, the hallmark of GERD, were reduced to a statistically significant degree after the procedure. Following the Stretta procedure, 27 of the 41 patients (approximately 66 percent) no longer required any PPI medication, and of the remaining 14 patients, all but one were on a lesser PPI dose.
``The Stretta procedure fills a very important need in the management of GERD, significantly improving acid exposure and medication use in the majority of patients I have treated,'' stated Dr. Richards. ``Given these results, and those of several other prospective trials, I offer the Stretta system as an option to those patients who are considering a laparoscopic anti-reflux procedure, but are better served by a less invasive endoscopic approach to their disease.''
John W. Morgan, Curon Medical's President and Chief Executive Officer, commented, ``We are delighted that this data, demonstrating the safety and efficacy of Stretta as a viable treatment option for GERD patients, was presented at such a well respected and well attended medical conference. We believe that the positive clinical study results will assist in the continued adoption of the Stretta procedure by laparoendoscopic surgeons and gastroenterologists, nationwide.''<<
Meanwhile, TWTI is getting another elephant stomping.
Cheers, Tuck |
