A Medical Device Daily

Xoft (Sunnyvale, California) said it has been granted a medical device license by the Medical Devices Bureau of Health Canada to sell and market the Axxent Electronic Brachytherapy System.

The company said its Electronic Brachytherapy (eBx) treatment platform is designed to deliver localized, non-radioactive, isotope-free radiation treatment in minimally-shielded clinical settings to help reduce recurrence of cancer and improve survival.

Commercially available in the U.S. since 2006 for treatment of early-stage breast cancer, endometrial cancer and skin and surface indications, the Axxent System also is FDA-cleared for use in the treatment of surface cancers or conditions where radiation therapy is indicated.

Xoft also said that it has received certification from the International Organization for Standardization (ISO) covering the design, development and manufacture of the Axxent Electronic Brachytherapy System and its components. The company has met the requirements of the ISO 13485:2003 standard.

"With this approval from Health Canada, we are proud to make this critical cancer treatment that can be delivered in virtually any standard medical exam room rather than in heavy lead-shielded vaults available to patients outside the U.S.," said President/CEO Michael Klein. "Combined with recent FDA clearances for new treatment applications, this approval is another . . . milestone supporting Xoft's mission of expanding the number of patients who can access radiation therapy and can dramatically benefit from it."

Radiation therapy is administered after breast-sparing surgery to hopefully kill stray cancer cells that might remain in the breast and is proven to reduce the rate of local recurrences and improve long-term survival.

Xoft said that as a cancer treatment platform, the Axxent System addresses a variety of oncological and non-oncological indications. The system delivers non-radioactive therapy directly to cancer sites with minimal radiation exposure to surrounding healthy tissue.

Designed to deliver electronic, X-ray-based radiation treatment, the system can be used in many clinical settings. Treatment can be performed without the need for a shielded room, allowing radiation oncologists and other medical personnel to be present during treatment delivery and minimizing patient anxiety.

Gambro introduces Artis System

In other Canadian med-tech regulatory news, Gambro (Lakewood, Colorado) reported the introduction in that country of its latest innovation in hemodialysis technology, the Artis Dialysis System.

The company said the Artis System "raises the standard for how to provide dialysis treatments through its functionality and simple-to-use interface."

The online system can be adapted to any treatment strategy and prescription, from conventional high-flux dialysis to advanced therapies such as hemodiafiltration (HDF).

Gambro said the Artis System has been well-received by clinicians in beta trials conducted at the University of Alberta Hospital in Edmonton and the Hôpital du Sacré-Coeur in Montreal." More than 70 treatments were performed over the course of three weeks and the company said clinicians found the Artis System to be easy to use.

"Artis includes an intelligent regulation system allowing for continuous therapy adjustments to the status of the patient for better comfort and more consistent delivery of the prescription," Gambro said.

The company pioneered the development of online HDF, which it said is "increasingly recognized as being superior to standard dialysis therapy for many patients [in stages] 1,2,3,4."

Gambro was the first to introduce HDF in North America using the Ultra Therapies system with the AK 200 Ultra S machine and Polyflux H dialyzer. The Ultra Therapies system has been used in Canada for the five years and has become known, the company said, for "excellent fluid quality and performance with documented excellence in clinical results."

The Artis system includes the introduction of Ultracontrol, a new method for simple, safe and effective administration of HDF treatments.

Japanese distributor for InSite's AzaSite

InSite Vision (Alameda, California) said it has signed an exclusive international licensing and distribution agreement for AzaSite 1% (azithromycin ophthalmic solution) with Nitten Pharmaceutical Co., a top 10 Japanese ophthalmic pharmaceutical company.

AzaSite contains a broad-spectrum antibiotic formulated with InSite Vision's patented DuraSite drug delivery vehicle to enhance the retention time of the antibiotic on the surface of the eye.

The company said AzaSite offers the benefit of a less-frequent and more-convenient dosing regimen in a safe, effective therapy for the treatment of bacterial eye infections.

Under the terms of the agreement, Nitten is responsible for securing regulatory approval and has exclusive rights to commercialize AzaSite for ocular bacterial infection in Japan and Taiwan. Nitten will pay InSite $1 million upon the execution of the license agreement, followed by milestone payments of $1 million upon the first regulatory submission and $1 million upon the first regulatory approval.

InSite Vision will initially be responsible for manufacturing AzaSite.

New leader in Japan for B&L

Bausch & Lomb Japan (Tokyo) has named Mitsuo (Mike) Hirose chairman, effective immediately. He has served on the company's board of directors since January.

Hirose most recently was representative director and chairman of Pacific Golf Group International Holdings KK. Prior roles included serving as president of Dai Nippon Printing Co.'s U.S. operations, and as a founder of corporate governance and ethics consultancy Maverick Japan.

He also has served as president and representative director for both Johnson & Johnson Japan and Johnson & Johnson Medical Co., as well as in other capacities for the Johnson & Johnson group of companies. He was responsible for introducing disposable contact lenses to the Japanese market, and was a committee member of the Central Social Insurance Medical Council of the Japanese Health, Labor, and Welfare Ministry until 2005.

Bausch & Lomb (Rochester, New York) is a global eye health company. Its products are available in more than 100 countries.

No Comments