Medtronic Launches Driver Sprint RX Bare-Metal Stent

March 31, 2009—Medtronic, Inc. (Minneapolis, MN) announced the international launch of the Driver Sprint RX coronary stent system, which received CE Mark approval in February 2009. The company plans to make the device commercially available in more than 100 countries worldwide. The new system combines the Driver bare-metal stent (BMS) with an improved delivery system that incorporates a new low-profile tip design and an enhanced shaft design. The company noted that these innovations are also incorporated in Medtronic's Endeavor Sprint and Resolute drug-eluting stent (DES) systems. According to the company, the Driver BMS is the platform of Medtronic's coronary stents and has been evaluated in a variety of research settings. The outcomes of more than 3,400 patients followed in both registries and randomized controlled trials have demonstrated the device's clinical efficacy. The device has demonstrated low short-term target lesion revascularization rates for Driver patients ranging from 3.4% to 9.4% at 6 months and from 6.7% to 7% at 9 months. In addition, approximately 600 Driver patients were followed to 4 years in ENDEAVOR II. Five-year data from this trial will be presented in May at the EuroPCR meeting in Barcelona, Spain. The target lesion revascularization rate for these Driver patients (n = 599) at 4 years is low for a BMS at 15.8%, the company stated. In other company news, on March 30, Medtronic announced approval of its Endeavor DES by the Japanese Ministry of Health, Labor and Welfare. Medtronic plans to launch the device immediately after the authorization of reimbursement, which is expected on May 1. According to the company, ENDEAVOR Japan (n = 99), a single-arm trial of Japanese patients with a primary endpoint of target vessel failure (TVF) at 9 months, is consistent with the results of the ENDEAVOR clinical program overall and contributed to the regulatory approval of the Endeavor DES in Japan. At 2 years, the TVF rate in ENDEAVOR Japan was 8.7%, which is comparable to the same measure in other trials of the Endeavor DES. There have been no instances of definite/probable stent thrombosis (early, late, or very late), with predictably low rates of death (2.2%) and myocardial infarction (2.2%). The Endeavor DES received CE Mark approval in August 2005 and was approved by the US Food and Drug Administration in February 2008.