A Medical Device Daily

Volcano (Rancho Cordova, California) reported approval of its s5i Integrated IVUS (intravascular ultrasound) System by regulatory authorities in Japan.

Volcano said it expects to launch the s5i into Japan — which it says represents the largest IVUS market worldwide — this quarter. The company noted that it has already launched the s5i Integrated IVUS system into the U.S. and Europe.

Volcano said that the s5i is its first IVUS system that can be integrated into new or existing cath labs. The company said it can now tailor an integrated IVUS solution to the unique user and workflow needs for virtually any vendor’s cath lab type or configuration, including multiple controllers and monitors, as well as flexibility in the physical location of the console. The s5i also incorporates Volcano’s real time VH IVUS tissue characterization functionality that enhances the interpretation of IVUS images, and ChromaFlo Stent Apposition analysis which helps physicians confirm proper stent expansion and placement.

Volcano said that the s5i IVUS is the only IVUS system to have undergone extensive safety and compatibility testing with the hardware imaging systems of the major providers, GE , Siemens , Philips and Toshiba .

Scott Huennekens, president/CEO of Volcano, said the approval “makes Volcano the only company to offer an integrated IVUS console to the largest worldwide IVUS market ... and believe that the lessons learned through IVUS by Japanese physicians will help increase the use of IVUS in the U.S. and Europe as well.”

Ron Waxman, MD at the Washington Hospital Center, said, “We recently performed an analysis of 7,000 patients at our center and concluded that the incorporation of IVUS guidance into everyday PCI procedures can reduce the patient risk of stent thrombosis by a statistically significant margin. We have always been IVUS advocates, but these new findings have driven IVUS use at the Hospital Center to its highest level ever. I recently presented this data in Japan where it was well received as interventional cardiologists in Japan have a high usage of IVUS and low rates of stent thrombosis.”

Conditional approval for U.S. IDE

China Medical Technologies (Beijing) said it has received conditional approval for its investigational device exemption (IDE) application from the FDA to begin a U.S. clinical trial of using its high-intensity focused ultrasound (HIFU) tumor therapy system in a limited number of patients with pancreatic cancer.

Conditions of the approval include a requirement for the company to provide responses to the questions raised by the FDA within a specified period of time.

The clinical trial will be performed at the University of Washington Medical Center (Seattle) after receiving approval from the university’s Institutional Review Board.

The company’s HIFU tumor therapy system is intended to be used in this trial to ablate targeted tumor tissue of the pancreas, with an indication for the palliation for pain associated with locally advanced or metastatic pancreatic cancer.

China Medical’s HIFU system was approved for sale by the State Food and Drug Administration of China in 1999. To date, more than 40,000 tumor patients in China, including patients with pancreatic, liver, breast, kidney and other solid tumors in the pelvic cavity, have received treatments by using the system.

“We are excited to have received the conditional approval of our IDE application from the FDA. We believe this marks an important milestone toward our application for pre-market approval of our HIFU tumor therapy system in the U.S.,” said Xiaodong Wu, chairman and CEO of China Medical. “We believe that our extensive clinical experience in [China] together with the experience of pre-clinical animal tests performed at the University of Washington for the IDE application will help us demonstrate the clinical safety and efficacy of using our HIFU system in treating pancreatic cancer patients during the clinical trial.”

Rosetta cites study on microRNA

Rosetta Genomics (Rehovot, Israel/North Brunswick, New Jersey), a microRNA company, said research findings published in the journal Molecular Cell suggest the potential for a specific, single microRNA — miR-34a — to be used as a drug candidate in cancer therapy to increase apoptosis, or programmed cell death, in the context of the tumor suppressor p53, which has been shown to prevent or slow the spread of cancer cells by facilitating apoptosis.

In this study by scientists from Rosetta Genomics and the Weizmann Institute of Science (Rehovot), activation of p53 in vivo in mice as well as in cultured human cells induced the expression of miR-34a.

Believing that miR-34a could itself play a role in cellular apoptosis, researchers introduced miR-34a directly into human cancer cell lines to determine its impact on tumor cell behavior. They said the results “clearly demonstrated” that over-expression of miR-34a led to increased cancer cell death as well as promoted other anti-proliferative activities.

The data presented in Molecular Cell is supported by other recent studies showing that miR-34a is under-expressed in central nervous system tumors.

MicroRNAs are a recently discovered, naturally occurring form of RNAi. They act as protein regulators and according to Rosetta Genomics, “have the potential to form the basis for a new class of diagnostics and therapeutics.” The company added that “since many diseases are caused by the abnormal activity of proteins, the ability to selectively regulate protein activity through microRNAs could provide the means to treat a wide range of human diseases.”

It said microRNA expression levels have been shown to be correlated with various disease states and to hold great potential as diagnostics and prognostic markers.