A Medical Device Daily

Smiths Medical, which is part of the Smiths Group (London), has opened the Smiths Medical High Altitude Laboratory at Namche Bazaar, Nepal. The lab, located at an altitude of 11,154 feet, is one of four main laboratories for Caudwell Xtreme Everest, described as the largest human biology study ever performed at high altitude.

More than 200 volunteers will be studied by about 60 doctors and scientists as they climb progressively higher to Everest base camp at 17,225 feet. More detailed research will be performed on a group of experienced mountaineer scientists who aim to climb to the summit of Everest at 29,035 feet to take the first measurement of arterial blood oxygen on the mountain's summit.

The laboratory, which opened last week, will operate until the end of May. It will be equipped with advanced medical testing equipment, including heart and lung function monitors and cardio pulmonary exercise testing equipment.

Caudwell Xtreme Everest is being conducted by doctors and scientists at the Center for Altitude, Space and Extreme Environment Medicine of the University College London (UCL) and is supported by John Caudwell, the entrepreneur/founder of The Caudwell Charity who is also a volunteer on the trek to Everest base camp. The laboratory also is the base for the Smiths Medical Young Everest Study (SMYES), which will investigate how nine British children cope with the low oxygen levels in the foothills of the world's highest mountain. SMYES is being conducted by doctors and scientists from Great Ormond Street Hospital and UCL's Institute of Child Health.

It is supported by Smiths Medical, which is a leader in respiratory care.

The doctors and scientists involved in Caudwell Xtreme Everest hope to make links between the human body at its limits during critical illness and the changes that occur to individuals at high altitude. In common with intensive-care patients, high-altitude mountaineers have a low level of oxygen in their blood.

The doctors and scientists involved in SMYES say they hope to improve the chances of survival for very sick children by investigating how healthy children's bodies cope and adapt at altitude. The project also aims to improve the quality of life of those with chronic/long term lung diseases and to develop new methods of detecting and treating children with disturbed sleep patterns.

The Smiths Medical High Altitude Laboratory will be run by Professor Monty Mythen, the Smiths Medical Chair of Anesthesia and Critical Care at UCL.

"What we learn from these people as they push themselves to the limit of human performance, will help us to understand what is happening to patients fighting for their lives on intensive care units," said Mythen. "At sea level, you can't tell who will cope and who won't. On Everest, if we can understand more about what makes someone a rapid adapter, we may be able to find the switches and adapters to help the others cope."

Smiths Medical, which donated a variety of medical equipment to the expedition, pioneered development of single-use devices to help people breathe. It reports having contributed around £4 million toward medical research at UCL over the last decade.

India okays Abiomed's Impella products

Abiomed (Danvers, Massachusetts) said that India's Office of the Drug Controller General (DCGI) has granted registration for the Impella 2.5 and Impella 5.0 circulatory support technologies.

The company said it plans to market the devices through its distributor, Interventional Technologies (Mumbai, India).

"[We are] committed to expanding our global distribution and access to our heart-recovery products," said Michael Minogue, president/CEO and chairman of Abiomed. "India represents an important marke, and we are pleased to provide hospitals and clinicians in the country with our Impella technologies, which help rest and recover the hearts of patients in acute failure.

Impella 2.5 is a ventricular assist catheter inserted percutaneously, in the cath lab, via the femoral artery into the left ventricle. Up to 2.5 liters of blood per minute are delivered by the pump from the left ventricle into the ascending aorta, providing the heart with active support in critical situations. The Impella 2.5 provides cardiovascular support for up to five days.

The Impella 5.0 technology consists of catheters that can be introduced percutaneously through a cut-down (Impella 5.0) or surgically (Impella LD5.0). These pumps can achieve flows of up to 5.0 liters per minute, and actively unload the ventricle, reducing myocardial workload and oxygen consumption while increasing cardiac output and coronary and end-organ perfusion. The Impella 5.0 support systems are intended to be used for up to seven days as left ventricular cardiac assist devices.

Both the Impella 2.5 and Impella 5.0 are available in Europe under the CE mark and are in pilot studies in the U.S. under investigational device exemptions.

1st patients Synergy-treated in Tokyo

After becoming Japan's first medical center to acquire Elekta's (Stockholm, Sweden) Synergy treatment system for intensity modulated and image guided radiation therapy (IMRT and IGRT), the University of Tokyo Hospital recently treated its first patients with the system.

The hospital is the first in Japan to use 3-D X-ray volume image-guided radiation therapy to irradiate cancer tumors with the system's greater precision.

Elekta Synergy is a digital linear accelerator equipped with imaging equipment that enables doctors to acquire images of the patient while the patient is in the treatment position. Clinicians can then use the imaging data to fine-tune the patient's position immediately prior to treatment.

Earlier this year, radiation oncologists at the hospital harnessed the imaging capabilities (X-ray volume imaging, or XVI) of Elekta Synergy and then used the system to treat a patient with a lung tumor.

"It was surprising to localize the tumor so efficiently and easily with the XVI functionality," said Keiichi Nakagawa, MD, associate professor in the department of radiology at the hospital. "A few days later, we used Elekta Synergy and XVI to image a neck sarcoma. Our therapists were very pleased to confirm by way of XVI that they had achieved a registration accuracy of less than 0.1 mm in all directions."

With the XVI technology, University of Tokyo Hospital doctors now will be using Elekta Synergy for cancer targets that demand precise localization before irradiation, such as those in the lung and head and neck, Nakagawa said.