Research In Brief
This article was originally published in The Gray Sheet
Executive Summary
BioMimetic bone graft: External fixation supported by BioMimetic Therapeutics' Augment injectable bone graft (formerly branded as GEM OS2) leads to faster bone formation in closed distal radius wrist fractures than external fixation alone, results from a 21-patient pilot study show. The Tennessee company announced Oct. 29 that CT scans by an independent, blinded radiologist showed that 40% of Augment patients in the study had at least 25% bone-fill across the fracture gap three weeks after the procedure, compared to zero control patients. The company notes that the patients in the Augment-treated group were, on average, more osteoporotic (lower bone density) than the control group. As of Oct. 28, the firm had enrolled 314 patients at 34 sites in its North American pivotal trial of Augment in foot and ankle fractures; it expects to complete enrollment of the planned 396-patient trial by early 2009 (1"The Gray Sheet" Aug. 18, 2008, p. 17)
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Research In Brief
Abbott carotid stent: Post-market data on carotid artery stenting with Abbott's Acculink and Xact in patients at high risk for standard carotid surgery show 30-day death and stroke outcomes are in line with recommendations by the American Heart Association for carotid endarterectomy surgery, according to article published online by Circulation: Cardiovascular Interventions March 6. High risk patients in the EXACT and CAPTURE2 trials have an overall 30-day death and stroke rate of 4.1% and 3.4%, respectively. The rates were 5.3% for symptomatic patients and 2.9% for asymptomatic patients undergoing carotid artery stenting. CMS angered CAS advocates last fall when it issued a memo declining to extend coverage for carotid artery angioplasty and stenting to high-risk patients ahead of study results on Acculink, Xact and Johnson & Johnson/Cordis' Precise system (1"The Gray Sheet" Oct. 20, 2008, p. 5). The release of the Abbott and J&J data support a reversal of CMS' October decision, the Society for Cardiovascular Angiography and Interventions argues in a March 9 press release
Research In Brief
Abbott carotid stent: Post-market data on carotid artery stenting with Abbott's Acculink and Xact in patients at high risk for standard carotid surgery show 30-day death and stroke outcomes are in line with recommendations by the American Heart Association for carotid endarterectomy surgery, according to article published online by Circulation: Cardiovascular Interventions March 6. High risk patients in the EXACT and CAPTURE2 trials have an overall 30-day death and stroke rate of 4.1% and 3.4%, respectively. The rates were 5.3% for symptomatic patients and 2.9% for asymptomatic patients undergoing carotid artery stenting. CMS angered CAS advocates last fall when it issued a memo declining to extend coverage for carotid artery angioplasty and stenting to high-risk patients ahead of study results on Acculink, Xact and Johnson & Johnson/Cordis' Precise system (1"The Gray Sheet" Oct. 20, 2008, p. 5). The release of the Abbott and J&J data support a reversal of CMS' October decision, the Society for Cardiovascular Angiography and Interventions argues in a March 9 press release
Research In Brief
Test improves DES outcomes: Routine measurement of fractional flow reserve (FFR) - the ratio of maximal blood flow in a stenotic artery to normal maximal flow - with St. Jude's PressureWire Certus guidewire-mounted sensor improves outcomes of drug-eluting stent implants in patients with multivessel coronary artery disease, according to results of the FAME trial published in the Jan. 15 New England Journal of Medicine. The 20-center trial randomized 1,005 patients with multivessel disease to undergo implantation of drug-eluting stents guided by angiography and FFR or drug-eluting stent implantation guided by angiography alone. The overall composite adverse event rates were 18.3% in the angiography-alone group and 13.2% in the FFR group. Adverse events included death, non-fatal myocardial infarction and repeat revascularization. The trial also showed that including FFR in the procedure saved money and only added one minute to the average procedure time (71 minutes versus 70 minutes). The average procedure cost was $6,007 in the angiography-alone group compared to $5,332 for the FFR group, partly because FFR measurement led to the implant of fewer stents. The FFR group received an average of 1.9 stents per patient compared to 2.7 for the angiography-alone group, even though patients in the FFR group had an average of 2.8 coronary lesions compared to 2.7 for the angiography-alone group. The study was sponsored by Medtronic, Friends of the Heart Foundation and St. Jude Medical/Radi Medical Systems