A Medical Device Daily

Fujita Health University (Toyoake, Japan) reported the installation of the AquilionONE, manufactured by Toshiba Medical Systems (Tokyo).

Installed in the latter part of October, the imaging system already has been used in examinations for more than 400 clinical cases.

The university said the area detector CT system “dramatically improves patient care with a significantly shorter scan time, which is especially beneficial in emergency cases.”

“Scanning the world’s first patient with this system was a unique opportunity. It was a memorable moment,” said Kazuhiro Katada, chairman and professor in the department of radiology, of Fujita Health University’s School of Medicine.

Katada and his team have been “deeply involved” in the development of many Toshiba scanners. For the area detector CT scanner, they contributed to development and gave Toshiba engineers “considerable feedback” from the viewpoint of patient care, diagnostic capabilities and efficiency.

One result of such feedback is the size of the detector in the new system. After Katada had evaluated a prototype unit in the early stages of development, which had 12.8 cm coverage in the patient-axis direction, he and the engineering team agreed to implement wider coverage in the final product, without compromising the 0.5-mm slice thickness.

As a result of the collaboration, the AquilionONE can scan a whole organ such as the heart or brain in a single rotation. It permits high spatial resolution, with a slice thickness of 0.5 mm and a maximum coverage of 16 cm.

With the system’s dynamic volume scanning, physicians can not only see a 3-D view of an organ, but also its blood flow and dynamic function. This reduces examination time as well as the exposure dose and contrast medium dose, and provides “significantly more accurate diagnosis, as the organ is scanned in a single rotation and in a single moment,” Toshiba said.

“The area detector CT scanner will improve diagnostic imaging dramatically and enhance the ability of physicians to diagnose serious diseases faster and more safely. Its capabilities are far beyond those of current MDCT scanners,” said Katada.

Fujita Health University provides community healthcare services, with 1,505 beds in the main hospital and satellites, along with its school of medicine.

Japan okays sale of Micrus microcoils

Micrus Endovascular (San Jose, California) reported receipt of approval from Japan’s Ministry of Health, Labor and Welfare to market its full line of stretch-resistant microcoils for the endovascular treatment of cerebral aneurysms in tht ountry.

The line includes the Cashmere, Presidio, HeliPaq and UltiPaq stretch-resistant embolic coils.

Sales of the microcoils will be managed by Goodman Co. Ltd., Micrus Endovascular’s exclusive distributor in the Japanese market.

“We are pleased to expand our product offering in Japan, where we have already developed a significant presence,” said John Kilcoyne, Micrus chairman/CEO. “Our Micrus bare-platinum microcoils are currently used in approximately half of all embolic procedures and, with the approval of our stretch-resistant microcoils, we now have the opportunity to build upon this foundation.”

He added: “We plan to immediately begin shipping stretch-resistant microcoil products to Goodman. Additionally, we continue to work with regulatory officials in Japan to gain approval for our Cerecyte bioactive microcoils.”

Micrus manufactures both implantable and disposable medical devices used in the treatment of cerebral vascular diseases and is developing products for the treatment of hemorrhagic and ischemic stroke.

Canada approves new version of Essure

Conceptus (Mountain View, California) reported the approval of its third-generation Essure permanent birth control system by Health Canada. System modifications include changes to the delivery system that reduce the number of steps a physician is required to perform during a placement procedure.

In addition to the enhanced ease of use, hysteroscopic visualization of the implant and placement markers was significantly improved, according to the company. A new DryFlow Introducer, which alleviates distension fluid loss, a major safety concern of hysteroscopists, is packaged with the product.

“These modifications, which were made in response to physician recommendations, were approved by the FDA this past summer [and] allows them to more easily add the Essure procedure to their practice services,” said Mark Sieczkarek, president/CEO of Conceptus. “We anticipate that the physician response in Canada will be similar and will foster wider physician adoption, giving more women opportunity to select permanent birth control without the need to undergo tubal ligation and the risks associated with surgery.”

“Canadian women who have decided that their family is complete, now have an even more advanced method of permanent birth control without surgery,” said Robert Sabbah, MD, chief of gynecology at Sacre Coeur Hospital in Montreal and assistant professor of obstetrics and gynecology at the University of Montreal. “We are looking forward to offering this non-incisional procedure to our patients seeking permanent birth control.”

NanoLogix files for international patents

NanoLogix (Hubbard, Ohio) said it has submitted international patent applications for BioNanoChannel and Hydrogen Bioreactor technology protection for China, India, Brazil and the European Union.

The company said those filings are necessary prior to the anticipated global roll-out of the BioNanoChannel rapid bacteria/microorganism detection technology and also contribute to the protection of NanoLogix’s ongoing Hydrogen Bioreactor development.

Chris Novak, director of intellectual property at the company, said, “The strength and improved focus of the new foreign cases arose from significant improvements to the originally filed provisional patent applications. We ... are excited about the potential for enhancing the patent protection for these new technologies.”

President/CEO Bret Barnhizer said, “This ... sets the stage for one of our corporate goals of pursuing licensing opportunities for use of our products internationally.”