A Medical Device Daily

Volcano Corp. (San Diego), a developer of products for the diagnosis and treatment of coronary and peripheral artery disease, reported an exclusive worldwide distribution agreement to initiate the formal launch of the Xtract thrombus aspiration catheter, manufactured by Lumen Biomedical (Plymouth, Minnesota). The Xtract thrombus aspiration catheter is available for immediate sale in the U.S. and Europe. This marks Volcano's entry into what it believes is at least a $70 million aspiration market, the company noted.

The Xtract thrombus aspiration catheter is FDA-cleared and is CE marked for use in coronary vessels, as well as some peripheral vascular applications. According to the company, the device incorporates three unique design attributes that enhance its performance. These include a single lumen design to maximize cross-sectional area, and in turn, thrombus suction; a circular, right angle tip for close-up access to clots; and a curved, directional tip to enable full sweep of the vessel. These design features enable physicians to offer a truly new approach for thrombus aspiration, Volcano said.

Scott Huennekens, president/CEO of Volcano, said the agreement with Lumen is "perfectly aligned with our corporate strategy, and builds on the unique value that Volcano offers to the interventional cardiology community." He added, "Volcano does not believe that a one-size-fits-all technology is capable of addressing complex disease states such as AMI, CTO and bifurcations, which continue to challenge clinicians today. Instead, we feel that application-specific tools such as IVUS-guided balloons, forward-looking IVUS catheters and tissue composition technologies can better target and treat the appropriate patient and lesion.

The Lumen Xtract thrombus aspiration catheter now gives Volcano a second-generation aspiration catheter to complement its IVUS and VH IVUS imaging tools in these challenging AMI patients, Huennekens said.

In other agreements and contracts news:

• MEI Development (Coral Springs, Florida) reported an agreement with GE Healthcare (Chalfont St. Giles, UK) that offers GE's customers the option of MEI's solutions, including development, financial, oncology, women's health and consulting services.

MEI says it provides turnkey solutions for physicians, outpatient facilities and hospitals that are interested in adding and updating imaging technology. MEI offers an array of services including determining project viability, creation and implementation of business planning, procurement of imaging equipment and complete project financing.

• TriLink BioTechnologies (San Diego) reported an agreement with Osmetech Molecular Diagnostics (Pasadena, California) to supply reagents for Osmetech's recently launched eSensor Cystic Fibrosis Carrier Detection (CFCD) system and the eSensor XT-8 system for Warfarin sensitivity.

TriLink is providing Osmetech with custom oligonucleotides, which are required reagents for the eSensor detection systems, the companies reported.

TriLink makes custom oligonucleotides, modified nucleoside triphosphates and CleanAmp PCR products for the diagnostic and OEM markets.

• BD Diagnostics (Franklin Lakes, New Jersey) and HandyLab (Ann Arbor, Michigan) reported an exclusive agreement for BD to commercialize its molecular assays on a new BD MAX system, an automated molecular diagnostic testing platform in development using HandyLab's recently launched Jaguar instrument. BD will focus initially on its BD GeneOhm line of molecular assays to detect major pathogens associated with healthcare-associated infections.

Released by HandyLab in November 2008, the Jaguar system is the first fully integrated bench-top molecular diagnostic system to provide hands-off operation, according to the company. The system incorporates clinical sample preparation, nucleic acid extraction, and microfluidic real-time polymerase chain reaction (PCR) amplification and detection. The self-contained workstation is designed to accommodate on-demand and batch workflows. It requires minimal laboratory space and minimal skill levels to generate up to 24 real-time PCR results in under two hours.

• SonoSite (Bothell, Washington) reported that Medical Simulation (MSC; Denver) has selected SonoSite's M-Turbo ultrasound as its preferred system for teaching clinicians central line placement procedures for their SimSuite Central Line Management Program.

According to the company, SonoSite's M-Turbo technology enables clinicians to confidently perform central line placement procedures. The system's imaging technologies – SonoMB, SonoHD, and SonoAdapt – provide healthcare professionals with crystal-clear imaging, better edge detection and needle recognition for ultimate visual guidance.

SonoSite develops hand-carried ultrasound. MSC provides full-service simulation training and education services to healthcare personnel, medical societies and medical product manufacturers.

• RaySearch Laboratories (Stockholm, Sweden) said it has entered into a long-term development and licensing agreement with Siemens Healthcare (Malvern, Pennsylvania). This new collaboration means that RaySearch will provide a number of treatment planning modules aimed at improving radiation therapy. The software modules will be integrated in Siemens' syngo Suite for Oncology, which is Siemens' integrated workflow solution for radiation therapy.

According to the company, the collaboration is expected to start generating revenues for RaySearch during 2011.