Not sure what to make of CURN right now. Stefaan's GI friend came back with a negative. Apparently feels it addresses the symptoms and not the etiology of GERD. There's also the issue of competition with C.R. Bard's suturing procedure, approved at roughy the same time. One of the question marks about the Stretta procedure was its long-term efficacy (same for Bard's); will the procedure need to be repeated? Given the cost, if it isn't permanent, it probably won't sell well.
Here's what I've been able to dig from public sources . . .
Via MedLine:
>>Radiofrequency energy delivery to the gastroesophageal junction for the treatment of GERD [In Process Citation]
Gastrointest Endosc 2001 Apr;53(4):407-15 (ISSN: 0016-5107)
Triadafilopoulos G; Dibaise JK; Nostrant TT; Stollman NH; Anderson PK; Edmundowicz SA; Castell DO; Kim MS; Rabine JC; Utley DS
Gastroenterology and Otolaryngology-Head and Neck Surgery Sections, VA Palo Alto Health Care System, California 94304, USA.
BACKGROUND: In this multi-center study, the feasibility, safety, and efficacy of radiofrequency (RF) energy delivery to the gastroesophageal junction (GEJ) for the treatment of gastroesophageal reflux disease (GERD) were investigated. METHODS: Forty-seven patients with classic symptoms of GERD (heartburn and/or regurgitation), a daily anti-secretory medication requirement, and at least partial symptom response to drugs were enrolled. All patients had pathologic esophageal acid exposure by 24-hour pH study, a 2 cm or smaller hiatal hernia, grade 2 or less esophagitis, and no significant dysmotility or dysphagia. RF energy was delivered with a catheter and thermocouple-controlled generator to create submucosal thermal lesions in the muscle of the GEJ. GERD symptoms and quality of life were assessed at 0, 1, 4, and 6 months with the short-form health survey (SF-36). Anti-secretory medications were withdrawn 7 days before each assessment of symptoms and pH/motility study. Medication use, endoscopic findings, esophageal acid exposure, and motility were assessed at 0 and 6 months. RESULTS: Thirty-two men and 15 women underwent treatment. At 6 months there were improvements in the median heartburn score (4 to 1, p < or = 0.0001), GERD score (26 to 7, p < or = 0.0001), satisfaction (1 to 4, p < or = 0.0001), mental SF-36 (46.2 to 55.5, p = 0.01), physical SF-36 (41.1 to 51.9, p < or = 0.0001), and esophageal acid exposure (11.7% to 4.8%, p < or = 0.0001). Esophagitis was present in 25 patients before treatment (15 grade 1 and 10 grade 2) and 8 had esophagitis at 6 months (4 grade 1 and 4 grade 2, p = 0.005). At 6 months, 87% no longer required proton pump inhibitor medication. There was no significant change in median lower esophageal sphincter pressure (14.0 to 12.0 mm Hg, p = 0.19), peristaltic amplitude (64 to 66 mm Hg, p = 0.71), or lower esophageal sphincter length (3.0 to 3.0, p = 0.28). There were 3 self-limited complications (fever for 24 hours, odynophagia lasting for 5 days, and a linear mucosal injury that was healed after 3 weeks). CONCLUSION: RF energy delivery significantly improved GERD symptoms, quality of life, and esophageal acid exposure while eliminating the need for anti-secretory medication in the majority of patients with a heterogeneous spectrum of clinical disease severity but with minimal active esophagitis or hiatal hernia. <<
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Here's Curon's decription of the procedure and an article about it:
msnbc.com
Anybody else have an opinion?
OK, so I've rejiggered my portfolio so I can leave this Sunday. I got my jury duty potponed till August so I can do this trip with out getting a warrant issued. And I should have some time to finally make good on my promise of putting up my take on CIPH, FWIW. By Sunday, really. Then you folks and BLUE HP are on your own for ~ a week. I'm just rather tired and a little burned out right now. The good news is that my portfolio won't need much attention for a while, so I should recover OK. I will leave some targets with Tom, perhaps.
Cheers, Tuck |
