A Medical Device Daily

Innocoll Pharmaceuticals (Athlone, Ireland), a subsidiary of Innocoll (Ashburn, Virginia), reported submitting a class III medical device application for its CollaRx Gentamicin Surgical Implant to the Australian Therapeutics Goods Administration.

The Gentamicin Surgical Implant is a biodegradable, "leave-behind" implant impregnated with the broad spectrum aminoglycoside antibiotic, gentamicin. The product was developed using Innocoll's collagen-based technology, CollaRx, approved in 49 countries as either a medicinal product for the treatment and prevention of surgical site infections or as a medical device.

Innocoll said more than 50 prospective clinical trials and published case reports have documented the safety and efficacy of the product over a variety of orthopedic, abdominal, colorectal, cardiothoracic, vascular and neurosurgical procedures totaling more than 7,500 patients.

It is currently marketed in Europe, Latin America, Middle East, Africa and Asia under various trade names.

The company said the National Surveillance of Healthcare Associated Infection in Australia (2001) estimated that surgical site infections occur in 2% to 13% of patients, depending on the type of surgery, and representing an annual healthcare cost of AUD$268 million ($220 million).

Dr. Michael Myers, president/CEO of Innocoll, said, "This filing in Australia follows on the heels of our recent Canadian submission and shows our commitment to growing the worldwide sales of our Gentamicin Implant through launches in new international markets and appointment of local distribution partners."

CollaRx is Innocoll's lead technology for the site-specific targeted delivery of a variety of drugs, with emphasis on antibiotics and anesthetics. The company acquired the product rights for the Gentamicin implant from Essex Chemis (Luzern, Switzerland), an affiliated company of Schering-Plough (Kenilworth, New Jersey).

MicroThermX 100 set for unveiling

BSD Medical (Salt Lake City) said it plans to unveil its new MicroThermX 100 thermal ablation system at the 88th annual German Radiology Congress, May 16-19 in Berlin.

The company said its systems offer a "complete solution" for thermal treatment of cancer via microwave/radio frequency technology. This solution, it said, requires systems that treat cancerous tissue with heat at temperatures that cause hyperthermia in the cancer, as well as a system designed to ablate diseased tissue with heat alone.

BSD said hyperthermia is used to kill cancer through heat while increasing the effectiveness of companion radiation therapy, adding that the MicroThermX 100 "represents an important part of [our] overall strategy to design systems that complement other cancer therapies and systems that ablate diseased tissue through heat alone."

Omni-Tract gets European patents

Omni-Tract Surgical (St. Paul, Minnesota) said it has been awarded two new European patents for technologies related to the company's table-mounted surgical retractors.

Saying the patents recognize its design relating to the use of cam technology and wishbone frames within a surgical retractor, Omni-Track termed its table-mounted retractor "the market leader in Europe."

The company said cam locking mechanisms are designed to provide faster and easier connections than standard screw-type, or threaded, mechanisms, while also adding strength to retractors.

"Time is a precious commodity in the operating room and our use of quick-locking cams and wishbone features on table-mounted surgical retractors has allowed surgeons to set up our system with maximum speed and ease," said Omni-Track President Dan Reuvers. "This important intellectual property recognizes our innovation and adds to the competitive protection we enjoy in Europe for one of our key design features."

Agendia licenses Asuragen's RNARetain

Asuragen (Austin, Texas), an oncology molecular diagnostic company and molecular biology service provider, said it has granted a non-exclusive license to Agendia (Amsterdam, the Netherlands), a gene expression analysis-based diagnostics and clinical testing firm.

RNARetain, also known as RNAlater in the life sciences market, is a technology used to stabilize expression profiles of both RNA and DNA in tissues and cells.

With the agreement, Agendia has the right to use RNARetain globally for human diagnostic applications.

"We are very excited about having RNARetain used in conjunction with [Agendia's] MammaPrint," said Matt Winkler, CEO of Asuragen. "The tissue preservative solution has found widespread clinical application and is uniquely suited for preserving nucleic acid profiles in solid tissues, both normal and cancerous, for subsequent clinical testing."

"Access to RNARetain will provide [us] with the opportunity to use a convenient shipping method," said Dr. Bernhard Sixt, CEO of Agendia, whose MammaPrint is a molecular diagnostic test based on gene expression profiling of 70 genes that it said form a reliable predictor of the risk of cancer recurrence in individual breast cancer patients.

CareAware product shown at UK meeting

Cerner (Harrogate, UK), the UK arm of Cerner (Kansas City, Missouri), demonstrated its CareAware RxStation technology at last month's Healthcare Computing tradeshow. The automated medication dispensing machine is the first in Cerner's line of CareAware connected devices.

"The CareAware RxStation demonstrates innovation in the medication process," said David Sides, managing director of Cerner UK. "RxStation allows for complete integration of the medication process, enabling healthcare organizations to provide a safer, quicker and more efficient patient experience."

Cerner said reports about medication errors in the UK "highlight the need for closed-loop medication systems." According to a 2000 study from the UK Department of Health, nearly 10,000 people every year are reported to have serious adverse reactions to drugs. A 2004 report found that the direct cost to the National Health Service of medication errors in its hospitals could run as high as £200 million-£400 million annually.

By automating medication ordering, verification, dispensing and administration, the CareAware RxStation device creates a closed-loop system for safer, more efficient treatment, the company said. The RxStation uses Cerner's CareAware global device architecture, which connects medical devices to the electronic patient record, allowing the device to receive the same medication information as clinicians and infusing the device with knowledge of the care process.