A Medical Device Daily

Reports indicate that Japan, which historically has had perhaps the slowest medical-device approval process globally, is eyeing steps to speed up its lengthy approval processes.

Philip Agress, vice president for global strategy and analysis at the Advanced Medical Technology Association (AdvaMed; Washington), said new reimbursement measures were adopted this past spring, and talks between the two governments and trade groups concluded last month indicate that companies may no longer be subjected to a full approval process required for even slight changes in products.

"Japan's regulatory approval process is the slowest in the industrialized world," Agress said. "A one- or two-year delay is not at all unusual, sometimes more."

Japan is the top international market for U.S. medical-device firms, with products representing some $20 billion in spending.

The possibility of having a smoother, speedier approval process in place marks a significant change in the way the Japanese government has looked at review processes for medical devices.

In many cases, Japan has required that clinical trials be conducted for certain products, even though other nations have not required them. Oftentimes when companies have conducted trials elsewhere before gaining approval in those markets, Japanese authorities have required that clinical trials be conducted on Japanese patients before products can be sold in that country.

"On paper, the requirements are the same for all companies [whether Japanese or otherwise]," Agress said, "but in practice, sometimes foreign companies have increased burdens."

Changes in the way products are approved now may allow U.S. companies greater access to the Japanese market.

First-in-man study begins for arterial stents

Flexible Stenting Solutions (Eatontown, New Jersey) said that a physician at Auckland City Hospital in New Zealand successfully implanted several of its third-generation arterial stents for the treatment of peripheral vascular lesions involving the superficial femoral and popliteal arteries.

This first-in-man clinical trial using a full range of stent sizes, including 120 mm, was performed by Associate Professor Andrew Holden, MD, director of interventional radiology at Auckland City Hospital and the principal investigator in the trial.

"The flexible stent handled both stenoses and occlusions in the femoro-popliteal artery segment as well as I had hoped with excellent immediate appearances following deployment" Holden said. "Overall, I felt the stent and delivery system performed very well in the acute phase and I await the longer term follow up in these patients with great interest."

Patients with lesion lengths up to 100 mm and fully occluded lesions were included in the study.

Flexible Stenting Solutions has developed a self-expanding stent technology to provide a wide range of vascular and non-vascular therapies. Treatment of femoro-popliteal disease is the first vascular application of its technology.

ISO certification for Singapore facility

Applied Biosystems (Foster City, California) reported that its Singapore facility has received an ISO quality certification, enhancing the company's ability to serve its customers.

The British Standards Institution Americas has awarded the company with an ISO 13485:2003 certification for in vitro diagnostic medical devices. This globally recognized management system standard enables CE marking to the In-Vitro Diagnostics Directive 98/79/EC of products for sale within the European Community.

Applied Biosystems, which currently markets instrument systems for research use only, obtained the certification to support its increased focus on commercial applications of molecular technologies. These include quality and safety testing, human identification, food and environmental testing, forensics, pharmaceutical manufacturing and clinical testing among others.

The company said its strategy is to continue to serve its customers by meeting their requirements to translate and implement scientific discoveries into applied, clinical and validated settings.

"This is an important milestone in [our] strategy to evolve based upon the changing needs of our customers," said Mark Stevenson, president/COO. "One of our goals is to implement and execute improvements in our quality management systems to support our initiatives in applied and validated markets. We are committed to meeting the requirements of our customers as they translate and implement scientific discoveries into the clinical setting."

Applied Biosystems is a global provider of instrument-based systems, consumables, software and services for the life sciences market. The company also makes systems and reagents for DNA sequencing, real-time polymerase chain reaction and mass spectrometry.

Taiwan distribution set for CellerateRx

Wound Care Innovations, a subsidiary of Wound Management Technologies (Fort Worth, Texas), reported that it has entered into a confidentiality agreement with an unnamed company to register and distribute its advanced wound care collagen product, CellerateRx, in Taiwan.

"We have had a tremendous response and inquiries from the international community about CellerateRx," said Cathy Bradshaw, president of Wound Care Innovations. "We are ... excited about the marketing and distribution of CellerateRx in Taiwan, as well as the entire international community."

CellerateRx is FDA-cleared for use on acute and chronic wounds, which include but are not limited to pressure ulcers (stages I-IV), traumatic wounds, diabetic ulcers, surgical wounds, venous stasis ulcers, ulcers due to arterial insufficiency, superficial wounds, and 1st and 2nd degree burns.

The company said CellerateRx's ease of application "can increase patient compliance and provide minimal lifestyle interruption."

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