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GE Healthcare Collaborates With Manipal Health Systems to Conduct Clinical Studies of Medical Diagnostic Products in India

Bangalore, India (ots/PRNewswire)

- Company's First Integrated Development Center (IDC) Opens in
Bangalore as Part of Strategic Development of its Global Clinical
Studies Program
GE Healthcare, a division of the General Electric Company
(NYSE:GE) today announced the opening of its first Integrated
Development Center (IDC) at Manipal Hospital in Bangalore, India.
The IDC in Bangalore is expected to conduct around 1,000 scans
annually as part of the planned clinical trials and will be part of a
series of global multi-country clinical studies in the United States,
the European Union and several other countries. Over time, GE
Healthcare will create more IDCs in key strategic locations globally.
Information obtained from this site will be combined with data
from other centres globally and contribute towards the development of
new contrast and molecular imaging agents or new indications for
existing agents.
The first studies will focus on Visipaque(TM) (iodixanol) an
isosmolar contrast agent that was launched globally by GE Healthcare
in 1996. Visipaque has been used in millions of X-ray and computer
tomography procedures to date. Contrast agents are used during
medical diagnostic procedures to provide image enhancement of tissues
and organs. Future studies will be extended to cover the company's
entire diagnostic imaging portfolio.
Under the terms of the collaboration, physicians at Manipal
Hospital will act as study investigators and provide clinical and
imaging services and administration in the hospital.
The IDC in Bangalore will play a crucial role in GE Healthcare's
ongoing global clinical research program and support its vision of
"Early Health" by helping to bring new diagnostic imaging agents to
market and working to address serious unmet medical needs in
oncology, neurology and cardiology.
Together, the collaboration between GE Healthcare and Manipal
Hospital will benefit local patients in a number of ways.
Particularly, the investment in imaging infrastructure will increase
access to the most advanced medical diagnostic technology available.
Manipal Hospital will conduct clinical research trials using a
wide range of GE Healthcare's innovative diagnostic imaging
technologies including its LightSpeed VCT, Discovery STe 16 slice
PET/CT scanner, Dual Head Gamma Camera with CT (SPECT/CT) and
TwinSpeed High Definition Magnetic Resonance (HDMR) imaging system.
Dan Peters, President and CEO of Medical Diagnostics at GE
Healthcare said, "The clinical studies in India are a key part of our
global strategy. We want to use our unique abilities in biology and
engineering to develop novel imaging agents that will provide
groundbreaking molecular diagnostic options for physicians and their
patients. The research efforts of GE Healthcare's Medical Diagnostics
R&D team are currently focused on functional and molecular imaging
agents that help doctors evaluate the physiology of disease and make
treatment decisions earlier with confidence."
Mr. V. Raja, President, GE Healthcare India, said: "We are
extremely pleased to collaborate with Manipal Hospital which is one
of India's most respected institutions. GE Healthcare and Manipal
Hospital are both driven by a desire to change the future of
healthcare by helping patients experience "Early Health", which
focuses on early diagnosis rather than late disease. Together, we
will be able to create one of the most advanced Integrated
Development Centers in the world. We will also be tapping into the
resources of the GE Global Research Centre here in Bangalore, as well
the expertise of our global Medical Diagnostics team."
Peters added, "This collaboration highlights our commitment to
supporting the development of the Indian healthcare system. India is
a great home for these clinical studies due to its rich R&D
capability, highly skilled medical professionals and sophisticated
medical infrastructure."
Dr. Ranjan Pai, Chief Executive Officer, Manipal Education and
Medical Group, said, "GE Healthcare has been our partner for a number
of years and we are excited to team up with them again to drive such
an important program forward."
The unique combination of a super speciality healthcare
institution - Manipal Hospital - with pharmaceutical development
resources and imaging equipment support
- GE Healthcare - and scientific expertise - GE Global Research
Centre - in one locality creates the excellent opportunity for
successfully carrying out complex trials more efficiently and
effectively, and thereby helping bring new diagnostic pharmaceuticals
to market sooner.
About GE Healthcare
GE Healthcare provides transformational medical technologies and
services that are shaping a new age of patient care. Our expertise in
medical imaging and information technologies, medical diagnostics,
patient monitoring systems, performance improvement, drug discovery,
and biopharmaceutical manufacturing technologies is helping
clinicians around the world re-imagine new ways to predict, diagnose,
inform and treat disease, so their patients can live their lives to
the fullest.
GE Healthcare's broad range of products and services enable
healthcare providers to better diagnose and treat cancer, heart
disease, neurological diseases, and other conditions earlier. Our
vision for the future is to enable a new "early health" model of care
focused on earlier diagnosis, pre-symptomatic disease detection and
disease prevention.
Headquartered in the United Kingdom, GE Healthcare is a US$15
billion Unit of General Electric Company (NYSE: GE). Worldwide, GE
Healthcare employs More than 43,000 people committed to serving
healthcare professionals and Their patients in more than 100
countries. For more information about GE Healthcare, visit our
website at www.gehealthcare.com.
About Manipal Health Systems
Bangalore based Manipal Health Systems is the pinnacle of the
dreams of the inimitable Dr. T M A Pai, a Gandhian and
philanthropist, who served the country with a mission to provide
quality education and medical facilities at affordable prices. He
laid foundation of India's first private medical college in 1953 at
Manipal, and in a span of 50 years, his pioneering effort has emerged
as Manipal Education and Medical Group (MEMG) which comprises over 57
institutions today. Manipal Health Systems is the healthcare division
of this pioneering institution.
The over 5000 bed Manipal Health Systems is by far the largest (in
terms of bed strength and single ownership), deepest (in terms of
rural reach) and most integrated (from rural welfare and corporate
clinics to tertiary care hospitals) Hospital Management Group in
Asia. Two of the health systems with hubs at Mangalore and Manipal
serve entire west coast of India from Goa to Kerala while the
flagship Bangalore health system serves patients from 20 countries
across the globe.
Manipal Health Systems has three tertiary care hospital located at
the hubs, 9 secondary care hospitals, 19 Primary Healthcare Centres,
7 rural welfare centres, Complimentary Clinics at Bangalore
International Airport and Mangalore domestic airport and over 55
Community Development projects. Manipal Health Systems treated 1.5
million patients as Out Patients and 0.4 mn as In Patients in
2005-06.
About Visipaque(TM):
X-ray/CT product for diagnosis of a wide range of diseases
including coronary heart disease and to aid in stent placement. The
only contrast media available for intravascular use that is isosmolar
(has the same osmolality as blood) at all iodine concentrations. It
is also formulated with the important electrolytes sodium and calcium
at physiological levels, to maintain electrolyte balance.
In the United States: Visipaque is not for Intrathecal Use. All
non-ionic, iodinated contrast media currently available inhibit blood
coagulation in vitro less than ionic contrast media. Clotting has
been reported when blood remains in contact with syringes containing
non-ionic contrast media. Caution must be exercised in patients with
severely impaired renal function, combined renal and hepatic disease,
combined renal and cardiac disease, severe thyrotoxlcosis
myelomatosis, or anuria, particularly when large doses are
administered. (See Precautions).
Prescribing Information(1) Visipaque(TM) iodixanol
Please refer to full national Summary of Product Characteristics
(SPC) before prescribing.
Presentation
An isotonic, aqueous solution containing iodixanol, a non-ionic,
dimeric contrast medium, available in three strengths containing
either 150 mg, 270 mg or 320 mg iodine per ml.
Indications
X-ray contrast medium for use in adults in cardioangiography,
cerebral angiography, peripheral arteriography, abdominal
angiography, urography, venography, CT enhancement, studies of the
upper gastrointestinal tract, arthrography, hysterosalpinography
(HSG) and endoscopic retrograde cholangiopancreatography (ERCP).
Lumbar, thoracic and cervical myelography in adults. In children for
cardioangiography, urography, CT enhancement and studies of the upper
gastrointestinal tract.
Dosage and Administration
Adults and children: Dosage for intravascular and oral use varies
depending on the type of examination, age, weight, cardiac output,
general condition of patient and the technique used (see SPC and
package leaflet).
Contra-Indications
Manifest thyrotoxicosis. History of serious hypersensitivity
reaction to Visipaque.
Precautions, Warnings, etc.
A positive history of allergy, asthma, or reaction to iodinated
contrast media indicates need for special caution. Premedication with
corticosteroids or H1 and H2 antagonists should be considered in
these cases. Although the risk of serious reactions with Visipaque is
regarded as low, iodinated contrast media may provoke serious,
hypersensitivity reactions. Therefore the necessary drugs and
equipment must be available for immediate treatment. Patients should
be observed for at least 30 minutes following administration of
contrast medium, however delayed reactions may occur. Non-ionic
contrast media have less effect on the coagulation system in vitro,
compared to ionic contrast media. When performing vascular
catheterisation procedures one should pay meticulous attention to the
angiographic technique and flush the catheter frequently (e.g. with
heparinised saline) so as to minimise the risk of procedure-related
thrombosis and embolism. Ensure adequate hydration before and after
examination especially in patients with renal dysfunction, diabetes
mellitus, paraproteinemias, the elderly, children and infants.
Special care should also be taken in patients with hyperthyroidism,
serious cardiac disease, pulmonary hypertension, patients predisposed
to seizures (acute cerebral pathology, tumours, epilepsy, alcoholics
and drug addicts), and patients with myasthenia gravis or
phaeochromocytoma. Particular care is required in patients with
severe disturbance of both renal and hepatic function as they may
have significantly delayed contrast medium clearance. All iodinated
contrast media may interfere with laboratory tests for thyroid
function, bilirubin, proteins, or inorganic substances (e.g. iron,
copper, calcium, and phosphate). In diabetic patients metformin
should be stopped when contrast media are used. The timing of this
should be amended based upon serum creatine/renal function levels.
(refer to SPC) An increased risk of delayed reactions (flu like or
skin reactions) has been associated with patients treated with
interleukin-2 up to two weeks previously. The safety of Visipaque in
pregnancy has not been established. The degree of excretion into
human milk is not known. Breast feeding should be discontinued prior
to administration and not recommenced until at least 24 hours after
administration.
Side Effects
Usually mild to moderate, and transient in nature, they include
discomfort, general sensation of warmth or cold, pain at the
injection site or distally. Serious reactions are only seen on very
rare occasions. Nausea, vomiting, and abdominal discomfort are rare.
Hypersensitivity reactions occur occasionally with symptoms such as
rash, urticaria and pruritus (immediate or delayed). Severe reactions
such as bronchospasm, angioedema, dyspnoea and fatal anaphylaxis are
very rare. Neurological reactions, headache, dizziness, seizures, and
transient motor or sensory disturbance (e.g. taste or smell
alteration) are very rare. Also reported very rarely; vagal
reactions, cardiac arrhythmia, hypertension and 'iodide mumps'.
Arterial spasm may follow injection. A minor transient rise in
creatinine is common. Renal failure is very rare. Post phlebographic
phlebitis or thrombosis is very rare. Gastrointestinal disturbances
including diarrhoea, nausea/vomiting and abdominal pain and systemic
hypersensitivity reactions occur occasionally (<1:10, >1:100).
Overdose
In the event of accidental overdosing, renal function should be
monitored for at least 3 days in addition to supportive measures.
Haemodialysis should be considered if needed.
Marketing Authorisation Number
Visipaque 150 mg I/ml - 60.635, 270mg I/ml - 60.636, 320mg I/ml -
60.637; Visipaque USP 150 mg I/ml - 62.916; Visipaque USP 270 mg I/ml
- 62.917; Visipaque USP 320 mg I/ml - 62.918.
Marketing Authorisation Holder
Amersham Health AS, Nycoveien 1-2, Postboks 4220 Nydalen, N-0401
Oslo, Norway.
Further information on request from: Amersham Health, The Grove
Centre, White Lion Road, Amersham, Bucks HP7 9LL.
Date of preparation: October 2004.
(1) Indications and approvals may vary in different countries.
Consult your local package insert for details. Further information
available on request.
Media contact:
    Sebastien Duchamp
    Communications Director
    GE Healthcare International
    +33-6-73-19-59-64

Contact:

Sebastien Duchamp, Communications Director, GE Healthcare
International, +33-6-73-19-59-64