A Medical Device Daily

OrbusNeich (Hong Kong) reported that the first patient has been enrolled in a randomized clinical trial of the Genous Bio-engineered R stent in China. A multicenter, randomized, controlled study, the trial will enroll 180 patients split evenly between the control and test arms at 11 sites countrywide, the researchers said.

The primary study objective is to demonstrate the safety and effectiveness of the Genous Bio-engineered R stent compared to the Medtronic (Minneapolis) Endeavor Sprint stent.

The study population will consist of patients aged 18 to 75 with symptoms of angina or myocardial ischemia. The primary endpoints are difference in Major Adverse Cardiac Event (MACE) rates between the two groups at 12 months following implant and 270 day angiographic Late Loss. Secondary endpoints include all-cause and cardiac mortality, myocardial infarction, in-stent thrombosis, MACE rates at 30, 60, 90, 180 and 270 days, as well as clinically driven Target Lesion Revascularization, Target Vessel Revascularization and Target Lesion Failure rates at 30, 60, 90, 180, 270 and 360 days.

The first patient was enrolled in the study at Beijing Chaoyang Hospital on Dec. 8.

"We believe that the Genous Bio-engineered R stent will provide an excellent treatment option to patients who present challenging cases with standard drug eluting stents," said Lu Shuzheng from Anzhen Hospital (Beijing), principal investigator of the trial.

Genous is OrbusNeich's endothelial progenitor cell (EPC) capture technology that promotes the accelerated natural healing of the vessel wall after the implantation of blood-contact devices such as stents. The technology consists of an antibody surface coating that attracts EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis, the company said.

"We are excited to take the Genous Bio-engineered R stent into this pivotal trial in China," said Al Novak, OrbusNeich's CEO/chairman. We expect that clinical data from this study will show positive benefits for patients, including those who often encounter challenges with today's drug eluting stents."

OrbusNeich's Genous Bio-engineered R stent has been commercially available in more than 60 countries since 2005.

Excelsior syrninges get Canandian approval

Excelsior Medical (Neptune, New Jersey), a manufacturer of pre-filled catheter flush syringes, reported that it has received a Medical Device License from Health Canada for its new, pre-filled catheter lock syringe to be sold in the Canadian marketplace.

The syringe contains the first commercially available heparin replacement solution – a combination of 4% sodium citrate and 30% ethanol in water for injection. The solution has similar anticoagulant properties to heparin so it helps maintain catheter patency without the possible negative side affects.

The new Excelsior solution has a major advantage over heparin, because it eliminates many of the potentially dangerous complications associated with heparin. Heparin in low concentrations has been the traditional locking solution for central venous catheters. But heparin use entails risks such as the potential for bleeding disorders, hemorrhaging due to an overdose, heparin induced thrombocytopenia, and the chances of being mixed with incompatible medications.

"There has long been a need for an affordable replacement for heparin locking solution that is broadly available commercially," said Bill Rice, Excelsior's president/CEO. "This new Excelsior Medical product has been in development for over three years, and included detailed studies on patency and catheter compatibility. We've also redesigned the syringe and plunger to maintain stability of the solution and a two-year expiration date."

PPD's Singapore lab earns CAP accreditation

PPD (Wilmington, North Carolina) reported that its global central lab operations in Singapore has earned accreditation by the College of American Pathologists (CAP), validating its ability to deliver high-quality, reliable data that meet the highest standard of excellence in enhancing patient safety and speeding drug development.

The Singapore facility is PPD's fourth central lab to achieve accreditation by the CAP Laboratory Accreditation Program.

"Achieving CAP accreditation six weeks after opening our Singapore facility demonstrates the expertise of our scientists and our commitment to excellence," said Steve Lobel, PhD, VP of PPD's global central laboratory operations. "Within weeks of opening our laboratory, we added new assay technologies and are supporting high-level testing to expand upon the services we offer our clients."

PPD opened its Singapore central lab last year in response to growing client demand in Southeast Asia. PPD also operates central labs in Highland Heights, Kentucky, Beijing, China, and Brussels, Belgium.

TomoTherapy expands into Australia, N. Zealand

TomoTherapy (Madison, Wisconsin) said it is expanding into Australia and New Zealand. The company recently signed a distribution agreement with Nucletron (Veenendaal, the Netherlands) and was awarded a contract by Queensland Health to supply the first TomoTherapy treatment system in Australia to Royal Brisbane & Women's Hospital (both, Brisbane, Australia).

"We are very pleased to be the first facility in Australia that will offer the advanced cancer treatment capabilities of the TomoTherapy system," said Roger Allison, MD, director of cancer care services at Royal Brisbane & Women's Hospital. "We anticipate it will optimize our treatment for many patients with complex cancer problems."

Nucletron is TomoTherapy's exclusive distribution partner in Australia and New Zealand.

"The expansion of TomoTherapy's reach into Australia and New Zealand underscores the growing recognition that our IG-IMRT solution enables facilities to provide state-of-the-art care, compared to conventional solutions," said Frederick Robertson, MD, TomoTherapy's president/CEO. "Our relationship with Nucletron and first installation with Royal Brisbane Hospital, will allow us to showcase the benefits of our robust radiation therapy solution to a large, new market."

SFDA approves Alex TriVantage

Candela (Walyand, Massachusetts) reported that the State Food and Drug Administration in China has approved the Alex TriVantage multi-wavelength, Q-switched laser system and the GentleMax multiple wavelength workstation for sale throughout the People's Republic of China, including Hong Kong. The receipt of the SFDA certificates will allow Candela to begin the sales process and launch official marketing programs for these products, creating a host of new market opportunities, the company noted.

The Q-switched Laser-Pumped-Laser (LPL) technology of the Alex TriVantage laser provides 755-nm, 532-nm and 1064-nm output wavelengths, making Alex TriVantage extremely versatile, according to Candela. The addition of a long-pulse mode at 755 nm offers advanced treatments for a wider variety of pigmented lesions (many unique to Asian skin) without long-term side effects. Beyond the treatment of benign pigmented lesions and the removal of multi-color tattoo inks, Alex TriVantage enhances the results of many skin rejuvenation treatments, making it an ideal system for optimizing fractional and other rejuvenation treatment results, the company said.

By integrating two of aesthetic laser medicine's leading devices, the GentleLASE and GentleYAG, into a configurable, upgradeable workstation, the GentleMax has made treatment for a wider range of patient concerns more readily available. The GentleMax laser system features both 755-nm and 1064-nm wavelengths and may be used to provide permanent hair reduction on all skin types and tanned skin as well as the treatment of vascular and pigmented lesions, wrinkle reduction and skin tightening. With GentleMax, it is now possible for one device to do the work of two or more.

MIT to produce Med-Jet products in China

Medical International Technology (MIT; Denver) reported that its Chinese joint venture has achieved a "major milestone" and received the production certification to produce Med-Jet products in China.

MIT China's production facilities were the subject of a recent visit by the State Food and Drug Administration, the company noted. These facilities were deemed suitable for medical device manufacturing, including the production of disposable accessories, by the SFDA and have therefore been granted a production certification.

Clinical trials of Med-Jet models MIT-MBX and MIT-H-III are set to begin in the near future. The obtainment of the production certification for human products together with the results from the clinical trials will represent an essential stepping-stone toward the ultimate goal of obtaining a licence to sell Med-Jet injectors in China, the company said.

Golden Meditech proposes name change

Golden Meditech (Hong Kong) said the board has proposed to change the company's name to Golden Meditech Holdings Limited, subject to shareholder approval.

Kam Yuen, CEO/chairman said, the proposed new name will better reflect the group's diversified healthcare operations built around its core competences, following the recent listings of its affiliates, China Cord Blood and FunTalk China Holding Limited in the U.S.