• Clinical Data (Newton, Massachusetts), which is commercializing pharmacogenomics to guide drug utilization, reported that its Vital Diagnostics division has received FDA clearance to market a wide-range C-reactive protein (wrCRP) assay, trademarked as the Nanopia wrCRP Assay. The Nanopia wrCRP is an in vitro diagnostic used for the quantitative measurement of C-reactive protein in serum or plasma. C-reactive protein is a blood component that increases rapidly in infections, tissue trauma, surgery or other injury to the body.

Endologix (Irvine, California) reported that four-year patient follow-up data from the company’s Powerlink System pivotal clinical trial supports the safety and effectiveness of the Powerlink as an endoluminal stent graft in protecting patients from rupture of the abdominal aortic aneurysm (AAA). Data from 192 patients treated with the Powerlink System in Endologix’s pivotal clinical trial was presented at the International Congress XIX on Endovascular Interventions. The mean follow-up patient time was 36.1 months with a range of .03 to 62 months. Only 26 patients from the follow-up group required a secondary procedure and most were treated for Type II endoleak, indicating that the need for the secondary procedure was not device related. All cohorts treated with the Powerlink System experienced aneurysm sac diameter and volume reductions, shrinking of the aneurysm sac around the device, and minimal change in the length of the aorta from the most distal renal artery to aortic bifurcation. Of the 192 patients followed for 48 months, 97.9% of patients were free from AAA-related mortality, there were no reported aneurysm ruptures, there were no ePTFE graft material failures, there were no cobalt chromium stent graft failures or fatigue, and there was only one late conversion that occurred at one year.

• Stereotaxis (St. Louis) reported that Central Baptist Hospital (Lexington, Kentucky) became the first U.S. center to treat a patient’s cardiac arrhythmia using the company’s partnered 3-D Localized Ablation Catheter. This diagnostic and ablation catheter recently received FDA approval for use with the Stereotaxis Niobe Magnetic Navigation System. The company said the approval provides Stereotaxis Niobe system users in the U.S. with 3-D localization of the catheter tip, a function that offers physicians precise and efficient control of the catheter tip with constant feedback as to the exact location of the catheter in the anatomy.

• Terumo Interventional Systems (Somerset, New Jersey), a unit of Terumo Medical, reported the launched of its Progreat Coaxial Microcatheter System. The new coaxial system combines Terumo’s Progreat microcatheter with a Glidewire GT – considered by many to be the “gold standard” in wires used to access difficult lesions. The Progreat Coaxial Microcatheter System is designed to increase procedural efficiency and reduce the risks of procedural problems, such as kinking. The Progreat Coaxial Microcatheter System includes a 0.021” Glidewire GT and incorporates an attached hub, which allows the wire to be preassembled and fixed via a lure-lock assembly onto a Terumo Progreat microcatheter. The combination allows the guidewire and microcatheter to be flushed simultaneously while still in the packaged hoop and it enhances the clinician’s ability to negotiate the vasculature and to reach the targeted vessel.

• Thermage (Hayward, California) reported receiving regulatory clearance from Health Canada to market a new indication for its non-invasive, skin-tightening ThermaCool system in that country. The new indication clears the ThermaCool system for the non-surgical tightening of lax and/or redundant tissue of the torso and extremities. Previously, Thermage had been cleared in Canada for non-surgical brow lift and non-surgical tightening of periorbital and facial tissue, including rhytids. This new indication gives clinicians regulatory clearance to treat off-face. To reflect the company’s direction and the expanding suite of procedure offerings, Thermage said it is unveiling a new brand called Body by Thermage. Thermage said it also received Canadian clearance recently to market its new 3.0cm2 ThermaTip. The new tip is twice as large as the current 1.50cm2 ThermaTip, enabling physicians to treat larger areas in less time. The tip also has an expanded treatment range allowing Thermage procedures to be performed on the most sensitive patients. Distribution in Canada began earlier this month.

• ThermoGenesis (Rancho Cordova, California) reported that the Medical Devices Bureau of Health Canada has issued the company a license to market the AXP System in accordance with Health Canada’s Medical Device Regulations. This allows GE Healthcare (Waukesha, Wisconsin), the exclusive AXP System distributor, the right to begin its sales and marketing efforts to cord blood banks and hospitals in that country. The AXP System is a new automated system that allows stem cells from cord blood to be harvested in a functionally closed processing set. The company said the AXP System automates what was typically an 18-step manual process while improving the recovery rates of the stem cells.

• Venetec International (San Diego) reported issuance of seven new patents on the company’s StatLock safety securement technology for medical catheters and tubing. Five of the new patents were issued in the U.S., plus an additional two patents in Australia. The seven patents encompass several StatLock devices, both existing products and those contemplated for future applications. The new patents follow the issuance last year of another 30 domestic and foreign patents. The company also reported favorable resolution of a trademark issue concerning action that had been contemplated by Medtronic (Minneapolis). The company said that Medtronic had elected to withdraw its application in the European Union for a trademark similar to Venetec’s protected StatLock mark.

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