A Medical Device Daily

Regeneration Technologies (RTI; Alachua, Florida), a processor of orthopedic, cardiovascular and other biologic implants, said it has received its first CE marks for several Sterling implants used in spinal, sports medicine and general orthopedic surgeries. The xenograft implants can now be distributed throughout Europe.

The implants receiving the CE mark include Sterling Cancellous Chips, Sterling Cancellous Cubes, Sterling Suture Anchor, Sterling Interference Screw ST, Sterling Interference Screw HT, Sterling Impacted Cortical Wedge, Sterling Impacted Cortical Ring, Sterling SR, Sterling Machined Dowel and the Sterling HTO Wedge.

The Sterling Biological Matrix provides surgeons an expanded supply of safe, sterile tissue that is a natural alternative to autograft, allograft and synthetic resorbable materials. The company said studies show that Sterling grafts maintain structural integrity and biocompatibility.

RTI said the addition of Sterling implants to its international distribution allows it to further tap into a $369.5 million international biologics market. The Sterling implants with the CE mark are available through the company's international distribution partners.

“Our plans to launch and grow our Sterling product line are advanced by these certifications,” said Brian Hutchison, RTI's chairman, president and CEO. “We can now bring sterilized xenograft to surgeons internationally, supplementing the unmet demand for biological solutions in surgery.”

He added: “It is RTI's goal to lead the biologics evolution in healthcare, and we remain committed to enhancing the lives of patients by pioneering health solutions through regenerative medicine.”

To receive the certifications, the Sterling implants were first assessed under the European Medical Device Directive 93/42/EEC Annex II Section 4. They also were required to satisfy Transmissible Spongiform Encephalopathies Directive 2003/32/EC, a more stringent standard that requires both proof of product safety and demonstration of a clinical need for the product.

RTI said it was able to prove the safety of the Sterling bovine line through its longstanding, exclusive agreement with a U.S. Department of Agriculture-certified, bovine spongiform encephalopathy-free closed and organic herd.

The Sterling implants also offer the benefits of RTI's BioCleanse Tissue Sterilization Process, which enables delivery of sterile xenograft implants with improved biocompatibility and preserved structural integrity.

Through the benefits of the BioCleanse process, the Sterling implants function as a natural biologic scaffold, allowing for rapid bone ingrowth into the implant and complete incorporation over time.

RTI processes allograft and xenograft tissue into shaped implants for use in orthopedic, cardiovascular and other surgeries. The company has distributed more than 675,000 allograft implants sterilized with the BioCleanse process with zero incidence of infection.

Applied Imaging a partner in study

Applied Imaging (San Jose, California) said its wholly owned subsidiary, Applied Imaging International, is one of three commercial partners accepted as a collaborator in the DISMAL(1)-project, a European-based, three-year biomarker study directed toward the detection and dissemination of tumor cells.

The venture was organized and funded by the European Union, and is comprised of 11 academic research centers and three commercial partners with long-term expertise in micro metastasis research. It is being led by Dr. Klaus Pantel, professor at the University Medical Center Hamburg-Eppendorf.

In its role in the DISMAL project, Applied Imaging will develop scanning hardware and software for fast and accurate detection of disseminated tumor cells (DTC) based on its Ariol platform's rare cell detection and analysis capabilities.

The project includes developments for improved DTC detection using high speed image processing technology, as well as the development of detection algorithms and data transfer software.

Robin Stracey, president and CEO of Applied Imaging, said, “We are pleased to be the only imaging company collaborating on this high-profile study into the detection and characterization of tumor cells. We expect our work on the DISMAL project will be incorporated into the circulating tumor cell system we are developing and will further enhance the presence of our Ariol systems in cancer research and diagnostics in the European market.”

The DISMAL project has received research funding from the European Community's Sixth Framework Program.

TomTec unveils RV function software

TomTec Imaging Systems (Munich, Germany) has introduced its 4D RV-Function software for right ventricular function analysis. The software enables fast measurements of RV functional parameters basing on 3-D echocardiographic datasets.

The company said current limitations in right ventricular diagnostics are mainly caused by the complex shape of the RV and can be overcome with this new product.

TomTec said it worked with cardiologists and pediatricians to develop an application that meets the growing demand for better and more accessible quantifications of right ventricular function, which is important in cases such as heart failure, pulmonary disease and congenital heart disease. Fast and accurate quantifications have an immediate application in managing and treating patients with such conditions.

The firm said the current “gold standard” for assessing right ventricular function is MRI, but the limited availability, high costs and time-consuming evaluation associated with MRI have limited its usefulness.

It added that 2-D echocardiographic techniques for quantitative analysis of the right ventricle, which are easier, low cost and relatively fast, are limited by the complex shape of the right ventricle.

TomTec said its new technology uses 3-D ultrasound data sets “to combine the ease and speed of echocardiography with the accuracy of MRI.” The software calculates a 3-D right ventricular surface model automatically from the endocardial contours in the 3-D data set. It uses that model to measure right ventricular end diastolic volume, end systolic volume and ejection fraction.

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