A Medical Device Daily

Medtronic (Minneapolis) reported the launch of the Resolute Integrity coronary stent system in Japan.

Indicated for the treatment of coronary artery disease, the Resolute Integrity drug-eluting stent offers a combination of superior deliverability with powerful performance as demonstrated in its long-term effectiveness and safety in more than 5,000 clinical study patients.

“The launch of the Resolute Integrity drug-eluting stent in Japan continues the strong momentum we've experienced this year with our novel next-generation stent, which is now available in all major markets worldwide,“ said Sean Salmon, president of Medtronic's coronary and renal denervation business. “The Resolute Integrity stent has been quickly adopted by physicians for its excellent clinical performance and improvement in deliverability; we look forward to now providing these benefits to Japanese physicians and their patients as well.“

The device's regulatory and reimbursement approvals earlier this year were supported by the results of RESOLUTE Japan, a prospective, single-arm, open-label study that enrolled 100 patients at 14 Japanese medical centers between March and October 2009.

The study's two-year results showed the durability of the treatment effect with the Resolute drug-eluting stent. As reported previously, RESOLUTE Japan study met its primary endpoint – with average in-stent late lumen loss of 0.13 mm at eight months post-implant. The Taxus drug-eluting stent, used as a historical control, had an average eight month in-stent late lumen loss of 0.42 mm.

The Resolute Integrity system features Medtronic's drug-eluting stent, which uses the Integrity platform to achieve deliverability without compromising radial or longitudinal strength.

Australians implant 'world first' bionic eye

Australian scientists said Thursday they had successfully implanted a “world first“ bionic eye prototype, describing it as a major breakthrough for the visually impaired.

Bionic Vision Australia (BVA; Victoria), a government-funded science consortium, said it had surgically installed an “early prototype“ robotic eye in a woman with hereditary sight loss caused by degenerative retinitis pigmentosa.

Described as a “pre-bionic eye“, the tiny device is attached to the first patient's, Dianne Ashworth, retina and contains 24 electrodes which send electrical impulses to stimulate her eye's nerve cells.

Researchers switched on the device in their laboratory last month after Ashworth had fully recovered from surgery and she said it was an incredible experience.

“I didn't know what to expect, but all of a sudden, I could see a little flash – it was amazing,“ Ashworth said in a statement.

Penny Allen, MD, the surgeon who implanted the device, described it as a “world first.“

Ashworth's device only works when it is connected inside the lab and BVA chairman David Penington said it would be used to explore how images were “built“ by the brain and eye.

Feedback from the device will be fed into a “vision processor“ allowing doctors to determine exactly what Ashworth sees when her retina is subjected to various levels of stimulation. “The team is looking for consistency of shapes, brightness, size and location of flashes to determine how the brain interprets this information,“ said Rob Shepherd, director of the Bionics Institute which was also involved in the breakthrough.

The team is working towards what it calls a “wide-view“ 98-electrode device that will provide users with the ability to perceive large objects such as buildings and cars, and a “high-acuity“ 1,024-electrode device.

Patients with the high-acuity device are expected to be able to recognise faces and read large print, and BVA said it would be suitable for people with retinitis pigmentosa and age-related macular degeneration.

Elekta wins tender in China

Elekta (Stockholm, Sweden) has won a what it calls a major tender where the Health Department of the People's Liberation Army (PLA) in China is expanding its capacity to treat cancer.

Cancer is one of the leading causes of death in China, according to the Earth Policy Institute, and with an aging population, the number of cancer patients is forecasted to grow significantly in the coming years. The PLA, which manages the military hospitals, is addressing the challenge presented by the high incidence and mortality of cancer by awarding a public tender to Elekta for the purchase of cancer management solutions.

Elekta will deliver a comprehensive range of clinical solutions, including Leksell Gamma Knife as well as linear accelerators and associated software. The total value of the contract amounts to some $35 million, making it Elekta's largest deal ever in China. The order will be booked when all conditions in the tender have been finalized.

Elekta makes products and solutions for treating cancer and brain disorders.