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Guidant utilized data from this trial to file for CE Mark approval of the GALILEO System.
evYsio also filed patent infringement cases against Guidant in France in 2001 and 2003, resulting in a ruling on December 17, 2004 against the Guidant Vision stent.
In addition to the new technology that will be used to collect data and the potential to link to the Medicare database to collect longer-term outcomes, the study's design and creation was the result of a unique collaboration between the clinical community, CMS, and the FDA," said Ron Lattanze, president, Guidant Endovascular Solutions.
The ABSORB trial will study the safety of bioabsorbable drug eluting stents developed by Bioabsorbable Vascular Solutions, an entrepreneurial subsidiary of Guidant Vascular Intervention established in 2003 in the Silicon Valley.
Guidant Corporation, its directors, and certain of its executive officers may be considered participants in the solicitation of proxies in connection with the proposed transactions.
At the Court's urging, the Pension Fund agreed to defer its request for a TRO, letting its motion stand in abeyance pending further developments in the case in exchange for the Guidant Board's agreement to keep the Pension Fund apprised of the status of merger negotiations with J&J, Boston Scientific and any other potential suitors and to provide the lead plaintiff with notice of any planned merger agreement.
The FDA letter, received December 23, 2005, references many of the 483 observations, noting actions taken by Guidant to address the observations and noting that Guidant will receive future communication regarding observations requiring additional action.
Guidant has a track record of recognizing the needs of physicians and the patients that they serve," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation.
The complaints charge Guidant and certain of its officers and directors with violations of the Securities Exchange Act of 1934.
With unanimous Guidant Board approval and all conditional regulatory clearances, the transaction is now expected to close in the first quarter of 2006, subject to Guidant shareholder approval.