August 22 – August 28, 2005
Aug 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.
Aug 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.
Aug 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.
Aug 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.
Aug23rd: 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.
Aug22nd: 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.
Aug 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.
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