NATICK, Mass. and ATLANTA, March 15 /PRNewswire-FirstCall/ -- Boston Scientific Corporation today announced 12-month results from its PERSEUS clinical program that demonstrated positive safety and efficacy outcomes in workhorse lesions for the platinum chromium TAXUS(R) Element(TM) Paclitaxel-Eluting Stent System compared to the TAXUS(R) Express2(TM) Paclitaxel-Eluting Stent System. The results also reported a similar safety profile and statistically superior efficacy outcomes in small vessels for the TAXUS Element Stent compared to a historical control group of patients receiving the Express(R) bare-metal stent.
"We are very encouraged by the one-year data demonstrating positive safety and efficacy outcomes for the TAXUS Element Stent and its innovative platinum chromium alloy," said Dr. Kereiakes. "In my experience, the TAXUS Element Stent offers increased flexibility, visibility and deliverability compared with currently available products. The PERSEUS data confirm that the proven TAXUS drug and polymer combination has been successfully transferred to the Element platform with excellent performance and comparable safety."
"Boston Scientific continues to build on its legacy of drug-eluting stent leadership through the development of our third-generation TAXUS Element Stent System," said Hank Kucheman, Executive Vice President and Group President, Cardiology, Rhythm and Vascular for Boston Scientific. "In addition, we remain the only company to offer customers a choice of two drugs."
The prospective, randomized (3:1) trial met its primary endpoint of non-inferiority for target lesion failure(2) (TLF) at 12 months with rates of 5.6 percent for the TAXUS Element Stent and 6.1 percent for the TAXUS Express Stent(3). The secondary endpoint of in-segment percent diameter stenosis at nine months as measured by quantitative coronary angiography (QCA) was also met.
Small Vessel trial
"The PERSEUS trials build on the extensive data from the TAXUS clinical program and extend the consistent outcomes seen in the TAXUS trials to the novel Element Stent platform," said Louis Cannon, M.D., of the Cardiac and Vascular Research Center of Northern Michigan in Petoskey, Michigan and the trial's Co-Principal Investigator. "With the positive outcomes of the TAXUS Element Stent in workhorse lesions and the superior efficacy data in small vessels, platinum chromium promises to offer significant advantages in acute performance with no compromise to safety."
The Company received CE Mark approval for the PROMUS Element Stent System in October 2009 and expects CE Mark approval for the TAXUS Element Stent System in the second quarter of this year. In the U.S., the Company expects FDA approval for the TAXUS Element Stent System in the middle of next year and for the PROMUS Element Stent System in the middle of 2012. In Japan, the Company expects approval for the TAXUS Element Stent System in late 2011 or early 2012 and for the PROMUS Element Stent System in the middle of 2012.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.
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(1) Based on bench testing. Data on file with Boston Scientific.
(2) TLF is defined as ischemia-driven target lesion revascularization (TLR) or myocardial infarction/cardiac death related to the target vessel. Complete trial design at Allocco et al., Trials 2010, 11:1.
(3) Bayesian probability of non-inferiority = 99.96 percent.
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