St. Louis selects Cardiac Science AEDs

Cardiac Science (Irvine, California), a manufacturer of automated external defibrillators (AEDs), said it has been selected as the exclusive provider of AEDs and comprehensive AED/CPR training and AED program management services for a citywide public access defibrillator (PAD) program launched by the city of St. Louis.

To initiate the program, about 90 Powerheart AED G3s were purchased from Cardiac Science. St. Louis's new PAD program makes it the latest major U.S. city to partner with Cardiac Science, joining San Diego, Minneapolis, Miami and Nashville, Tennessee.

The PAD program is being coordinated by the St. Louis Fire Department, which in addition to planning the deployment of AEDs is reaching out to private citizens and organizations through a public awareness campaign on the importance of defibrillation therapy and the use of AEDs to treat victims of sudden cardiac arrest.

ReNu Medical avoids 483 report

“No 483 report“ came over the public-address system at ReNu Medical (Everett, Washington), followed by applause and loud cheers.

Chief Operations Officer Bruce Pierson and CEO Randy Long had received word that the FDA found no deficiencies at the ReNu device-reprocessing laboratory in Everett and would not be issuing a 483 report. “ReNu received what would be the equivalent of a gold medal to an Olympic athlete,“ said Pierson.

Issuing a 483 report is standard operating procedure for the FDA and is usually issued after the agency completes an inspection. This report outlines any and all deficiencies and provides the inspected facility management a clear direction and understanding of what must be corrected or changed.

“It is almost unheard of for this report not to be issued,“ ReNu said.

Millionth Taxus DES implanted

Boston Scientific (Natick, Massachusetts) reported the implantation of its millionth Taxus Express2 paclitaxel-eluting coronary stent system, marking a major milestone for the company and for the treatment of coronary artery disease. The Taxus received the CE mark in January 2003 (Medical Device Daily, Jan 23, 2003) and FDA approval in March 2004 (MDD, March 8, 2004).

“The implantation of our millionth Taxus stent system is a significant symbolic achievement for Boston Scientific,“ said Jim Tobin, company president and CEO. “We are gratified that the Taxus system has become the preferred treatment option for clinicians, but more important, we are pleased that so many patients have benefited from this innovative, life-enhancing technology.“

Gregg Stone, MD, director of cardiovascular research and education, Center for Interventional Vascular Therapy at Columbia University Medical Center (New York), said, “This is a noteworthy milestone for Boston Scientific, for physicians and for patients. This product has truly revolutionized how we treat coronary artery disease and dramatically advanced the practice of interventional cardiology.“

Earlier last week, Boston Scientific reported that it had launched its Taxus Liberte paclitaxel-eluting stent system in 18 countries. The Taxus Liberte system features the company's next-generation Liberte coronary stent.

The company plans to launch the Taxus Liberte system in Europe later this year and in the U.S. next year, subject to regulatory approval.