J.P. Morgan Healthcare Conference In Brief
This article was originally published in The Gray Sheet
Executive Summary
NxStage Medical: The Lawrenceville, Mass., company is planning to file a 510(k) for a nocturnal indication for its System One home hemodialysis system by March after recently wrapping up a clinical trial, CEO Jeff Burbank said during a Jan. 13 session at the J.P. Morgan Healthcare Conference in San Francisco. System One is indicated for home use, but not specifically nighttime use, and patients usually undergo five to six dialysis sessions per week, the exec noted. The NxStage device is the only home hemodialysis system cleared by FDA, but Baxter, already a leader in peritoneal dialysis, intends to launch its own home-based hemodialysis device in 2011 (1"The Gray Sheet" Sept. 21, 2009)
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Research In Brief
Boston Scientific PLATINUM program: Company said March 16 it has completed enrollment of the pivotal, randomized, controlled trials of its Promus Element everolimus-eluting stent in small vessels and long lesions. The studies compare Promus Element to historical controls of patients treated with Boston Scientific's Taxus Express2 paclitaxel-eluting stent. The small-vessel trial includes 94 patients with de novo lesions from 2.25 mm to less than 2.50 mm in diameter and up to 28 mm in length; the long-lesion trial enrolled 102 patients with de novo lesions from 24 mm to 34 mm in length and from 2.50 mm to 4.25 mm in diameter. Promus Element received CE-mark approval last fall (1"The Gray Sheet" Nov. 9, 2009). Results of the PLATINUM Workhorse trial comparing Promus Element to Promus, which will be used to support U.S. FDA approval, are expected in early 2011. The firm revealed results of the PERSEUS trial of its platinum-chromium Taxus Element stent at the American College of Cardiology meeting in Atlanta
Research In Brief
Boston Scientific PLATINUM program: Company said March 16 it has completed enrollment of the pivotal, randomized, controlled trials of its Promus Element everolimus-eluting stent in small vessels and long lesions. The studies compare Promus Element to historical controls of patients treated with Boston Scientific's Taxus Express2 paclitaxel-eluting stent. The small-vessel trial includes 94 patients with de novo lesions from 2.25 mm to less than 2.50 mm in diameter and up to 28 mm in length; the long-lesion trial enrolled 102 patients with de novo lesions from 24 mm to 34 mm in length and from 2.50 mm to 4.25 mm in diameter. Promus Element received CE-mark approval last fall (1"The Gray Sheet" Nov. 9, 2009). Results of the PLATINUM Workhorse trial comparing Promus Element to Promus, which will be used to support U.S. FDA approval, are expected in early 2011. The firm revealed results of the PERSEUS trial of its platinum-chromium Taxus Element stent at the American College of Cardiology meeting in Atlanta
Correction
Gen-Probe: In the Jan. 18, 2010 issue (1p. 14), a "J.P. Morgan Healthcare Conference In Brief" item incorrectly notes that Gen-Probe plans to submit a 510(k) to FDA for its Aptima HPV assay to run on its Tigris system. The company plans to submit a PMA