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