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We were very pleased to see 100 percent survival at 30 days with the 100 high-risk patients treated with the SAPIEN XT valve-in-valve procedure in the continued access registry," said Danny Dvir, M.
Meanwhile, enrollment in REALISM, the continued access registry, continues to be strong with 120 patients treated as of September 1st 2009.
Investigational Device Exemption (IDE) Scandinavian Total Ankle Replacement (STAR) - Continued Access Registry
The WATCHMAN device continues to be implanted in a Continued Access Registry (CAP) while the product is under review at the FDA.
Since March, the company has presented encouraging clinical data for the pivotal ENDEAVOR II study, the ENDEAVOR II Continued Access Registry, and the confirmatory ENDEAVOR III study, as well as consistent longer-term data from ENDEAVOR I and ENDEAVOR II.
To date over 70 devices have been implanted in the Continued Access Registry.
This physician symposium will offer a comprehensive look at the Medtronic Endeavor drug-eluting stent system, including presentations on: 12-month ENDEAVOR II results, 24-month ENDEAVOR I results, the ENDEAVOR II Continued Access registry and a product overview and perspective.
the leader in the development of devices for the percutaneous repair of cardiac valves, announced today the start of enrollment in the REALISM (Real World ExpAnded MuLtIcenter Study of the MitraClip(R) System) study, a continued access registry.
The ENDEAVOR II Continued Access Registry completed enrollment of an additional 300 patients in July and will provide additional safety and efficacy data for product approvals globally.
Additionally, we have enrolled our first patient into the Continued Access Registry at Washington Hospital Center under the direction of Prof.
Food and Drug Administration has approved the inclusion of the clinical results from the Continued Access Registry in the labeling of the Vascular Solutions Duett(TM) sealing device.
Food & Drug Administration to commence the Continued Access Registry of the Vascular Solutions Duett(TM) sealing device in the United States.