October 14th:
FDA Seizes Baxter's Infusion, Syringe Pumps
The FDA has seized roughly 6,000 infusion pumps and 850 syringe
pumps manufactured by Baxter Healthcare.
The seizure involved Baxter's Colleague Volumetric Infusion Pumps
and Syndeo PCA Syringe Pumps, which were being held at two
facilities in Illinois. Baxter had placed a voluntary hold on
shipments of the products earlier this year after batter problems
were discovered, the firm said.
The FDA's latest action affects only Baxter's inventory, and not
the customer-owned pumps currently being serviced by Baxter, the
firm said. Baxter also said it is unable to provide loaner pumps to
customers who have removed pumps from service. The company, however,
reiterated the fact that it has developed an aggressive corrective
action plan for the products, and remains in discussions with the
FDA.
Roughly 250,000 Colleague infusion pumps are in use worldwide,
including more than 200,000 in the U.S., Baxter said. There are
approximately 5,000 Syndeo pumps in use worldwide.
Medtronic Introduces CD HORIZON
SPIRE(TM) Spinal System
Medtronic, Inc. announced the U.S. market availability of CD HORIZON
SPIRE(TM) Spinal System for use in spinal surgery. This minimally
invasive product allows surgeons to fixate the spine by attaching a
plate to the spinous process of the vertebral body during spinal
fusion surgery as a supplement to the CD HORIZON® Rod and Screw
System. The announcement was made today during the Congress of
Neurological Surgeons meeting in Boston.
The CD HORIZON SPIRE Spinal System can provide surgeons with an
easy and rapid insertion without fluoroscopy. Its use can
potentially minimize soft tissue disruption.
Report by GAO Blasts FDA'S PLAN B Decision making
An unreleased federal report bolsters allegations that the FDA
made a political rather than a scientific decision when it delayed
Barr Pharmaceuticals' application to sell the Plan B contraceptive
without a prescription, congressional sources say.
The Government Accountability Office's (GAO) initial report on the
FDA's handling of Plan B (levonorgestrel) shows the agency took
numerous unprecedented steps to inject politics into its decision,
according to congressional staff who have reviewed the GAO's
findings. While the report will not be publicly available until
November, the document was on display for lawmakers and their staff
beginning Oct. 12. Staffers say the GAO didn't distribute copies of
its preliminary findings due to the "sensitivity" of the subject.
The GAO concluded the FDA took authority for the Plan B decision
away from the staffers that usually make such decisions, made an
initial decision to reject the application before internal and
external reviews were completed, and delayed its decision to
consider issues such as adolescent promiscuity, one Hill staffer
said.
October 13th:
Supreme Court Rejects Claim against Medtronic
The U.S. Supreme Court has refused to hear a claim against
Medtronic alleging the company produced faulty devices, ensuring
manufacturers liability protection for devices that have been
approved by the FDA.
The Court's denial of a request for review leaves intact a lower
court ruling that Medtronic was not liable for faulty leads in its
pacemakers. The company had pulled its 4004 and 4004M leads from the
market because of concerns that the polyurethane insulation would
degrade. But the company did not ask doctors to remove leads that
had already been implanted in patients.
Fourteen patients challenged this practice, alleging negligence.
Of those patients, 12 needed additional heart surgeries to replace
the leads and two had theirs capped.
The rejection marks the third time in five years that the high
court has refused to intercede on behalf of patients seeking to sue
Medtronic. Lower courts have generally rejected such claims.
More Experienced Doctors Equal More Successful ICD Implants
Patients who have implantable cardioverter-defibrillators (ICDs)
implanted by more experienced physicians are less likely to have
complications, a recent study finds.
A report published in the Oct. 18 issue of the Journal of the
American College of Cardiology found that patients using doctors
with less experience installing ICDs are more likely to suffer from
infections and mechanical complications. The report is the result of
the largest study of the relationship between the volume of ICD
procedures done and the outcome for patients.
The researchers analyzed Medicare records for 1999 through 2001
to determine how many patients receiving ICDs received hospital care
for complications within 90 days of the procedures. Medical
complications were more common among patients using less experienced
doctors. Physicians who implanted at least 11 ICDs per year had
lower levels of both mechanical complications and infections, the
report found.
Enrollment in Stroke Treatment Trial Halted Amid Safety
Concerns
Eli Lilly and Centocor have temporarily suspended enrollment in a
late-stage clinical trial of their heart treatment ReoPro after a
review of preliminary trial data revealed a potential safety problem
with the drug.
The Phase III trial, which is examining ReoPro (abciximab) as a
potential treatment for acute ischemic stroke, was stopped after the
study's independent safety and efficacy monitoring committee (SEMC)
observed a safety concern in the trial data. Lilly and Centocor
didn't reveal details about the safety concern.
The SEMC is in the process of evaluating the entire risk-benefit
profile of ReoPro for acute ischemic stroke patients before coming
to a final recommendation on whether or not enrollment in the trial
should resume. Patients currently enrolled in the trial will not
receive additional doses of ReoPro and data for these patients will
be reviewed before the SEMC provides its recommendation on how to
proceed with the Abciximab in Emergent Stroke Treatment Trial-II (AbESTT-II).
October 12th:
FDA Issues Guidance for Reprocessor's Mark on SUDS
Manufacturers that reprocess single-use devices (SUDs) must
attach to the products a prominent and conspicuous mark identifying
the firm's name or recognized symbol, according to a new FDA draft
guidance that offers practical suggestions on what is necessary for
a corporate identifier to be recognized during ordinary use.
A manufacturer's mark will be considered prominent and
conspicuous based on four factors: available space, contrast, font
or graphic readability and meaning, says the guidance, published
Oct. 11 in the Federal Register.
Under the 2005 Medical Device User Fee Stabilization Act (MDUFSA),
the labeling provision on corporate marks, which previously applied
to all manufacturers, was limited to reprocessed SUDs and the
manufacturers who reprocess them, the guidance says. The change also
applies to original equipment manufacturers that reprocess SUDs.
Panel Meeting to Center on Postmarketing Commitments
The FDA will call on its Oncologic Drugs Advisory Committee next
month to provide recommendations on how drugmakers can better meet
postmarketing commitments for drugs cleared under the accelerated
approval process.
The advisory panel will meet Nov. 8 to "identify difficulties
associated with completion of Phase IV commitments" and "provide
advice to sponsors to assist in the planning and execution of
postmarketing commitments of newly approved drugs," the FDA said.
The meeting will take place in Gaithersburg , Md.
October 11th:
FDA May Recall St. Jude Defibrillators
The FDA may issue a recall of older St. Jude Medical implantable
cardioverter defibrillators (ICDs) after the company reported that
background levels of radiation in the atmosphere might cause the
devices to suddenly lose power.
St. Jude Medical recently announced that in 60 of the 36,000
Photon DR, Photon Micro VR/DR and Atlas VR/DR devices, exposure to
cosmic radiation affected the ICD's memory. But the company said
that no serious patient injuries or deaths have been reported
because of the flaw.
In its recent physician advisory, St. Jude Medical recommended
that doctors should perform routine device monitoring every three
months for patients with these ICDs. The company is also offering a
remote monitoring product, Housecall Plus, at no charge. "St. Jude
Medical has taken a conservative, proactive approach in notifying
the medical community of this anomaly," said Mark Carlson, a member
of an independent panel that reviewed the issue for the company.
Medtronic Submits First PMA for Its Heart Stent
Medtronic recently submitted its first pre-market approval (PMA)
module to the FDA for its Endeavor drug-eluting heart stent. The PMA
represents the company's first step to get U.S. approval for the
device, Medtronic said.
The Endeavor stent is made of a cobalt alloy and has a unique
modular architecture designed to enhance deliverability over bare
metal stents. The stent is coated with the proprietary drug compound
ABT-578 and phosphorylcholine, a polymer designed to simulate the
outside surface of a red blood cell and mimic the structure of the
natural cell membrane. Medtronic received European approval for the
stent in July.
Survey: Most Physicians Support Ad Moratorium for New Drugs
More than 80 percent of physicians believe a moratorium should be
placed on direct-to-consumer (DTC) advertising immediately following
the approval of a new drug, according to a survey conducted by HRA
Research.
Of the 2,015 doctors participating in the Internet survey, 81
percent responded that DTC advertising should be prohibited for new
prescription drugs for a period of time after FDA approval to allow
physicians to familiarize themselves with new products. The survey
included both office- and hospital-based physicians from virtually
all practice areas.
While the large majority of physicians favored some type of
moratorium on DTC ads, there was less agreement about the type of
ban that should be implemented. Forty-three percent of survey
participants favored a mandatory ban for some limited period of
time, 33 percent recommended a voluntary ban with each
pharmaceutical company deciding when to begin advertising to
consumers, and 24 percent said it is not necessary to place either
type of ban on DTC advertising.
October 10th:
Guidant Launches Heart Stent System in Japan
Guidant recently launched its Multi-Link Vision RX Coronary Stent
System in Japan after receiving the Japanese government's regulatory
and reimbursement approvals. This new stent system uses cobalt
chromium, which is stronger and more radiopaque than stainless
steel, allowing these devices to be thinner without compromising
visibility, the company said.
Japan's Ministry of Health, Labor and Welfare recently approved
the device in coronary vessels, in 8 mm to 28 mm lengths. The system
has demonstrated positive clinical results, with a 1.9 percent
target lesion revascularization and a 15.7 percent binary restenosis
rate at six months.
"The MULTI-LINK VISION RX offers excellent clinical results for
the treatment of coronary artery disease," noted Greg Davis,
president of Guidant, Japan K.K.
Military to Fund Prosthetics Research
The Department of Defense is beginning a multimillion dollar
research program to improve upper-body prosthetics, prompted by the
large number of troops who have lost hands and arms in the Iraq and
Afghanistan wars, USA Today reported.
Over the next four years, the Pentagon will spend nearly $35
million to develop improved artificial arms, which perform more like
a real arm. The device would be guided by the central nervous
system.
The investment is the largest pool of funding for prosthetics in
at least a decade, a spokeswoman for the Defense Advanced Research
Projects Agency said. That office will award the research contracts.
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