• Acculis (Denmead, UK) reported the clearance of its latest device for coagulating and killing unwanted tissue during surgery. The device, designed for coagulations at the surface of the tissue fires controlled high-power microwave energy into the target area causing it to heat rapidly and the cells to die. Liver surgeons can use the Acculis MTA system to address tumors inside the liver using its existing needle probes that take the microwave energy to the center of tumors. Using the same control unit, this latest device allows surgeons to address deposits on the surface of the liver without using a needle.

• Direct Flow Medical (Santa Rosa, California) reported the first human use of its 18 Fr Percutaneous Aortic Valve (PAV) System. In the first patient treated with the 18F PAV system the physicians were able to safely complete the first ever successful retrieval of the device through an 18F sheath before easily positioning and deploying a second device. The Direct Flow device is a non-metallic, expandable cuff, bovine pericardial tissue valve that allows the physician to assess the hemodynamic outcomes prior to final deployment of the device. The repositionable "stentless" valve conforms to the native annulus resulting in tight sealing of the valve in the annulus which minimizes any paravalvular leaks. The reduction of aortic insufficiency is believed to improve clinical status in these high risk patients with significant co-morbidities including coronary heart disease and congestive heart failure.

• Exiqon Diagnostics (Tustin, California) said it now offers KRAS Mutation Analysis through its CLIA laboratory in California. Cancer treating physicians now have access to this critical test for their advanced stage colorectal and non-small cell lung cancer patients who are candidates for anti-EGFR therapy. Recent studies strongly correlate the presence of KRAS mutations in colorectal cancer patients with lack of response to cetuximab and panitumumab, shorter progression-free survival (PFS) and shorter overall survival. Studies performed in NSCLC have shown that mutations in the KRAS gene are strongly predictive of resistance to tyrosine kinase inhibitors such as gefitinib and eroltinib.

• Medrad Interventional/Possis (Warrendale, Pennsylvania) reported that it has reached key milestones in bringing the Paccocath technology closer to market as an option for the more than 14 million patients in the U.S. and Europe who suffer from peripheral arterial disease (PAD). These milestones include the selection of physician investigators for U.S. clinical trials and the completion of a new manufacturing facility. In routine treatment of stenotic or occluded vessels, doctors widen the narrowed vessel using an angioplasty balloon catheter. In some cases, a stent is then placed to hold the vessel open. However, these treatments may have limited effectiveness since, for most patients, the vessels often re-occlude within a year after treatment. The Paccocath technology is a drug matrix applied to the balloon of an angioplasty catheter. When the catheter is inflated to dilate the narrowed vessel, an anti-restenotic drug is released directly to the diseased area. Clinical results to date show that using the Paccocath technology during an angioplasty procedure keeps the vessels open wider over time compared to standard angioplasty and published reports of other current standard-of-care therapies. Cotavance is the brand name of the drug-eluting balloon angioplasty catheter that is currently being developed by Medrad Interventional/Possis that utilizes the Paccocath technology. Medrad is in the process of obtaining CE-mark certification and seeking FDA approval for the Cotavance product. Bayer Schering Pharma AG (Berlin) is the owner of the Paccocath technology and is developing it for market through Bayer affiliate, Medrad. Another major milestone in bringing Paccocath technology to market has been the completion of a balloon coating Center of Excellence facility in Minneapolis, which is the primary site for balloon coating and the development of future coating technologies and drug formulations. Expanding the Paccocath technology to patients with heart disease, B.Braun Melsungen AG (Berlin) has licensed the technology for use in its SeQuent Please drug eluting balloon catheter, which recently received CE certification for the treatment of narrowing of the coronary arteries.

• Tornier (Edina, Minnesota) reported the first human implant of a shoulder arthroplasty prosthesis based on the company's pyrocarbon technology. Designed to meet the unique soft tissue biocompatibility requirements of the shoulder joint, the prosthesis utilized in this procedure was developed and manufactured by Tornier's dedicated Pyrocarbon Center of Excellence based in Grenoble, France. The implant is not yet commercially available. The soft tissue biocompatibility of pyrocarbon is ideal for extremity joint repair or replacement, the success of which is much more dependent on soft tissue functionality than is the replacement of large joints such as the hip and knee.

• Viztek (Jacksonville, Florida) has introduced a full-featured mammography viewer that integrates with its Opal-RAD PACS solution as well as any PACS supporting DICOM Query/Retreive to deliver high quality display of detailed mammography exams. The new multi-modality viewer eliminates the need for a separate mammography workstation and utilizes the same image database as general patient images for streamlined image management and storage. It supports diagnostic quality viewing of full-field digital mammography, (FFDM), CR and MR breast images.