RSNA News - November 2004
Product News
FDA Approval
MR Technology for Targeted Imaging Studies
The Food and Drug Administration (FDA)
has given marketing clearance to GE Healthcare to expand its EXCITE
data pipeline to include an advanced MR imaging technology.
This new technology, for GE Signa® 1.5 T and 3.0 T MR systems,
increases speed and power to help clinicians gather more data in
shorter periods of time. It also allows a greater range of targeted
MR studies, such as of the heart, brain, liver and lower legs.
"These exams, in many cases, will expose patients to lower
doses of contrast than are typically required for x-ray or CT studies,
" said Dennis Cooke, vice-president of global MR for GE Healthcare.
The new EXCITE release will enable new targeted studies including
high-clarity vascular images of the lower legs, extremely high-resolution
images of the liver with shorter breath holds and better organ coverage
than was previously possible, and RealCARD real-time imaging of
the heart with the resolution of MR at the speed of ultrasound,
without the need for breath holding or ECG gating.
FDA Approval
Carotid Stent System
The FDA has also cleared the first carotid
stent system designed to reduce the risk of stroke.
Guidant Corporation's RX ACCULINK carotid stent system and
RX ACCUNET embolic protection system were approved for use
in patients who have had symptoms of a stroke or whose carotid artery
is at least 80 percent blocked, and who are not good candidates
for the surgical alternative.
"Stenting is an established therapy that has been used successfully
for years to treat heart and peripheral vascular disease. The approval
of a carotid stent represents a minimally invasive breakthrough
therapy for patients at risk of stroke who are ineligible or at
high risk for traditional surgery," said Beverly Huss, president
of endovascular solutions for Guidant.
The FDA is requiring Guidant to conduct post-approval studies to
confirm the stent's performance and to assess its long-term safety
and effectiveness in preventing strokes.
New Product
Molecular Imaging Tool
Siemens has introduced a new work-in-progress
tool for molecular medicine. Developed in collaboration with the
Center for Molecular Imaging Research (CMIR) at Massachusetts General
Hospital in Boston, the MIPortal* is an information technology platform
designed to provide molecular imaging research laboratories with
access to archiving and processing of imaging and non-imaging data.
"We expect the research being conducted at CMIR to lead to
the discovery of new ways to detect and diagnose disease,"
said Mohammad Naraghi, senior vice-president of business development
at Siemens Medical Solutions. "Because we are integrated into
the research process, Siemens will be able to bring new molecular
imaging solutions to the market more quickly, allowing physicians
to implement these advanced technologies in clinical practice, ultimately
benefiting patient care."
*MIPortal is not commercially available in the U.S.
New Product
Disposable Endocavity Needle Guide
CIVCO Medical Instruments has introduced
a new disposable endocavity needle guide for use with Siemens BE9-4
transducers on the G60 S and G50 ultrasound systems.
The needle guide fastens securely into the locating features of
the transducer, directing instruments according to on-screen guidelines.
Because the needle guide is disposable, it helps reduce the risks
associated with cross-contamination.
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