A Medical Device Daily

Medical Simulation (Denver), a provider of medical training and education services, said it has launched the Edwards Sapien Transcatheter Heart Valve (THV) training program in Europe.

Edwards Lifesciences (Irving, California) received CE-mark approval for its Sapien transcatheter aortic heart valve with the RetroFlex transfemoral delivery system last September, and the CE mark for the Sapien valve with the Ascendra transapical delivery system in December.

Medical Simulation said it has worked with Edwards since 2004 to develop a comprehensive THV procedure training program for surgeons and cardiologists during U.S., Canadian and European clinical trials. With CE-mark approval in Europe, the program is now focused on providing commercial product training for physicians that includes online training, an advanced combination of didactic and simulation education integrated with cases studies and hands-on product education with expert physician proctoring.

“Simulators contribute tremendously giving physicians the opportunity to become familiar with the procedure before they actually have to perform it in patients,” said John Webb, MD, of St. Paul’s Hospital (Vancouver, British Columbia), the physician course director for THV Simulation Development.

Medical Simulation’s SimSuite simulation technology integrates the THV product into a comprehensive patient simulator, allowing physician trainees to conduct the procedure as close to real life as possible, including managing early learning-curve complications that the company said can now be avoided with proper techniques learned in the clinical trials.

“This program is unique in that we have designed the most advanced simulation education program to train both surgeons and cardiologists together on one of the most complex procedures being performed with catheters,” said Bill Younkes, CEO of Medical Simulation. “Edwards has made a commitment to provide the best training available to its customers, with the ultimate goal of a well-served patient. The transfer of knowledge that occurs with this level of education is clearly a huge step forward in the healthcare industry.”

Edwards’ Sapien THV integrates balloon-expandable stent technology that leverages the company’s bovine pericardial tissue and 30 years of design and manufacturing expertise. The Sapien valve is compressed onto a balloon to the approximate diameter of a pencil and then either threaded through the patient’s circulatory system from the leg (transfemoral delivery) or inserted between the ribs (transapical delivery) and deployed across the patient’s diseased aortic valve — all while the heart continues to beat.

In both cases, the procedure is completed without open-heart surgery or cardiopulmonary bypass, providing a treatment option for patients considered high risk for traditional open-heart surgery.

Medical Simulation provides training and education services to medical product manufacturers, medical societies, and hospital personnel, including clinical specialists, sales representatives, physicians, nurses, and technicians.

All English trusts now have PACS

The UK Department of Health said digital technology that has “revolutionized” the way the National Health Service (NHS) captures, records and uses patient X-rays and scans is now being used in every hospital trust in England.

Picture archiving and communications systems (PACS) are replacing the traditional methods of capturing X-rays and scans on film and paper, enabling clinical images to be stored electronically and viewed on screen.

The Department of Health said the roll-out of PACS has been a major element in the National Program for IT, “which is helping the NHS to deliver better, safer care to patients via new computer systems and services.

Using the PACS technology, healthcare professionals can look at images at the touch of a button. X-rays and scanned images are available to view on screens in different locations such as X-ray departments, outpatient clinics, operating theaters and inpatient wards simultaneously.

The NHS said the system also gives clinicians instant access to old X-rays and scans, enabling the comparison of old images with new. “This is especially useful when treating long-term conditions. Images can also be rotated, enlarged and manipulated in other ways, helping clinicians diagnose conditions more quickly and accurately.”

Health Secretary Alan Johnson said that the benefits of PACS “in terms of improved patient care are massive. This innovative technology speeds up and improves the accuracy of diagnosis, saves time and improves the quality of care.”

He said that NHS trusts “are reporting that the time taken for radiologists and radiographers to issue reports to clinicians have typically been halved from more than six days to less than three and these report that turnaround times continue to fall, with some hospitals reporting all imaging within 24 hours.”

In addition to improved patient care, the introduction of PACS also is saving money, Johnson said, with trusts reporting an average saving of £250,000 in their first year of using the technology.

The UK government introduced the program to implement PACS in all English trusts in 2004. The final trust to receive a PACS as part of the national program was Leeds Teaching Hospitals Trust in December, marking the completion of a three-year process that has seen 127 trusts across England receive PACS.

Voluven IV solution okayed by FDA

The FDA has approved Fresenius Kabi’s (Bad Homburg, Germany) Voluven, an intravenous solution that prevents and treats a dangerous loss of blood volume, a condition that sometimes occurs during and after surgery.

Significant blood losses can cause a rapid drop in the volume of red blood cells and plasma circulating through the body. This can lead to shock, which is potentially fatal.

Voluven contains a synthetic starch that does not dissolve in water. It is made by linking individual starch molecules together and combining them with a salt solution, similar to the salt concentration typically found in blood.

The IV solution expands the volume of blood plasma — the liquid portion of the blood — and thus draws fluid into small blood vessels known as capillaries. The company said that studies have shown that during orthopedic surgery, Voluven was as safe and effective as Hespan, an approved starch solution, in expanding blood volume.

Fresenius Kabi is a maker of infusion therapy products.

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