A Medical Device Daily

With the final approval of a research project into prostate cancer, the Dutch Center for Translational Molecular Medicine (CTMM; Eindhoven, the Netherlands) reported the successful completion of a €265 million funding for translational (bench-to-bedside) medical research, making CTMM one of the largest public-private partnerships in the world. This pivotal point in the organization's development firmly positions the Netherlands as one of the world's leading destinations for translational biomedical research, the organization said.

"The €15 million allocated to this prostate cancer project, which brings the total allocated CTMM funding to €265 million, should enable the project team to make a real difference to the diagnosis and treatment of a disease that counts among the biggest killers of men," said Peter Luijten, CTMM Chief Scientific Officer.

With this final project approval, CTMM said ir has fulfilled the initial objectives of its business plan by establishing public-private research consortia to address the world's most prevalent diseases. The CTMM project portfolio now comprises 18 projects conducting translational molecular medicine research into innovative new techniques for the diagnosis and treatment of cancer, cardiovascular, neurodegenerative and infectious/auto-immune disease. In total, more than 100 partners from industry and academia are involved in the projects, which are funded on the basis of 25% from industry, 25% from academia and 50% from the Dutch government.

AccuVein vein illuminator receives CE mark

AccuVein (Cold Spring Harbor, New York), maker of the AV300, the world's first hand-held, non-contact vein illumination device, reported that its medical device now carries a CE mark, enabling the company to commence European sales of AccuVein's AV300.

"Receiving approval to ship the AV300 to Europe is an important step in bringing this beneficial device to healthcare practitioners around the globe," said Stephen Conlon, president of AccuVein. "Furthermore, Europe provides a significant growth opportunity for AccuVein allowing us to build upon our successful launch in the United States."

AccuVein recently achieved an International Organization for Standardization (ISO) 13485 Certification, acknowledging that its quality management processes meet international standards.

The AccuVein AV300 helps advance patient care in a variety of settings by assisting healthcare professionals in locating the vein quickly for blood draws, intravenous lines and delivery of medications. Weighing only 10 ounces, the AV300 uses point-and-click technology the healthcare professional simply presses a button and positions the device above the patient's skin to display a map on the skin of underlying veins. With a range of hands-free options, the AV300 can quickly switch between a hand-held and hands-free mode, freeing the practitioner's hands to perform the venipuncture.

CryoLife gets CE mark for BioFoam technology

CryoLife (Kennesaw, Georgia), an implantable biological device and cardiovascular tissue processing company, said it has received CE mark approval for its BioFoam surgical matrix (BioFoam). The CE mark allows immediate, unrestricted commercial distribution of BioFoam in the European community for use as an adjunct in the sealing of abdominal parenchymal tissues (liver and spleen) when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. BioFoam is the second product from the company's protein hydrogel technology platform to receive a CE mark.

The company said it plans a controlled clinical launch of BioFoam at up to six centers in the UK, Germany, France and Italy to support its initial marketing efforts. Based on the number of liver and spleen procedures performed annually in the Europe, CryoLife estimates the annual European market opportunity for BioFoam to be about $30 million and more than $100 million on a worldwide basis.

"We are excited about securing our first approval for the use of BioFoam in organ resection surgery and look forward to continuing our development efforts to bring BioFoam into the U.S. market," said Steven Anderson, CryoLife president/CEO. "Over the past four fiscal years, the U.S. Department of Defense has allocated approximately $5.4 million to CryoLife for the development of products containing a protein hydrogel, which is the primary component of BioFoam."

In December 2008, CryoLife received conditional approval from the FDA to conduct the feasibility phase of the company's BioFoam IDE submission for liver parenchymal sealing. The feasibility phase will enroll a total of 20 subjects at two investigational sites in the U.S. Before beginning this phase, the company must receive final approval of the study protocol and related documents from the FDA and an additional approval of the study from the U.S. Department of Defense. CryoLife is in the final stages of this approval process.