August 22 - August 28, 2005

August 26th: Revolutionary BIOTRONIK Implantable Defibrillator Automatically, Wirelessly Transmits Intracardiac ECG for Arrhythmia Monitoring and Event Notification

BIOTRONIK today announced that the first United States implantation of the Lumos DR-T implantable cardioverter defibrillator (ICD) was performed at Loyola University Medical Center in Chicago, IL. The surgical procedure was performed by Niraj Varma MD, FRCP, Director of Cardiac Electrophysiology Laboratories at Loyola. The Lumos defibrillator has recently been approved by the U.S. Food and Drug Administration and represents the latest in BIOTRONIK's pioneering development of remote patient management systems for implantable cardiac devices.

August 26th: FDA Final Rule Clarifies Primary Mode of Action for Combination Products

The FDA's final rule defining the primary mode of action (PMOA) of combination products will give firms a better understanding of how the agency determines which FDA office takes regulatory oversight of their products, says an FDA official. The document, released Aug. 24, sets forth an algorithm that the FDA will use to assign combination products when the agency cannot determine with "reasonable certainty" which mode of action "provides the most important therapeutic action of the combination product" - which is the definition of PMOA.

August 26th: EU Clears J&J's Takeover of Guidant

The European Union cleared Johnson & Johnson's planned purchase of heart device maker Guidant Corp. on Thursday, provided some operations are sold, but J&J said the deal closing will be delayed because key U.S. regulators have yet to sign off. Johnson & Johnson spokesman Jeffrey Leebaw said the $25.4 billion cash and stock deal could not be finished until after the U.S. Federal Trade Commission makes a decision. In a regulatory filing Thursday afternoon, J&J said it hoped to complete the deal in the fourth quarter. The deal might also be delayed due to recent recalls of many Guidant products. Thursday's approval by the European Union's executive commission came with the condition that the combined company sells operations in some niche markets for cardiovascular devices to guarantee fair competition in the EU's 25 member states.

August 24th: Medtronic Introduces Mystique for Spinal Surgery

Medtronic has introduced its MYSTIQUE Resorbable Graft Containment Plating System for cervical spine fusions. The new plating system uses a high-tech biologic material that is reabsorbed by the body over time, offering spinal surgeons a feature not found in traditional metal implants, said Medtronic. When surgery is needed to alleviate nerve or spinal cord compression, a surgeon may perform an anterior cervical discectomy and fusion, where he or she makes a small incision in the front of the neck to reach the cervical spine. The disc is removed and the space is filled with bone graft. The MYSTIQUE plate is used for stabilizing the weak bony tissue around the fusion, preventing bone graft dislodgement and facilitating healing.

August 23rd: FDA warns Boston Scientific on 'serious' problems

The U.S. Food and Drug Administration warned Boston Scientific Corp. over "serious regulatory problems" with its medical devices, including its Taxus stent, according to a letter made public on Tuesday. The warning, which also targeted the device maker's Vaxel ports and Symmetry catheter, followed an inspection of Boston Scientific's Quincy, Massachusetts, facility earlier this year. The company responded to the FDA in June, but the agency's warning letter said the firm did not give enough details about its corrective actions.

August 22nd: Jury Awards $253M to Widow in First Vioxx Case
Verdict: Merck sold the painkiller while knowing heart risks

A Texas jury Friday awarded $253.4 million in damages to the widow of a 59-year-old man who had used the controversial painkiller Vioxx. It was the first lawsuit -- in either state or federal court -- involving the now-banned painkiller, part of a family of drugs called cox-2 inhibitors. The Texas District Court jury of seven men and five women awarded Carol Ernst, the widow of Robert Ernst, the money as compensation for her mental anguish, as well as the loss her husband's companionship and earnings, and for punitive damages.

August 22nd: Breakthrough In Embryonic Stem Cell Work; Researchers Turn Skin Cells Into Embryonic Stem Cells In Study

Harvard scientists say they have fused an adult skin cell with an embryonic stem cell in a potentially dramatic development that could lead to the creation of useful stem cells without first having to create and destroy human embryos. They said they were able to show in their early research that the fused cell "was reprogrammed to its embryonic state." "If future experiments indicate that this reprogrammed state is retained after removing the embryonic stem cell DNA - currently a formidable technical hurdle - the hybrid cells could theoretically be used to produce embryonic stem cells lines that are tailored to individual patients without the need to create and destroy human embryos," said a summary of the research reported on the Science site. That could lead to creation of stem cells without having to use human eggs or make new human embryos in the process, thereby sidestepping much of the controversy over stem cell research.