• CryoCath Technologies (Montreal) reported that Dr. Douglas Packer from the Mayo Clinic (Rochester, Minnesota) presented additional data from the feasibility stage of the Cryo System Trial Of Paroxysmal Atrial Fibrillation (STOP AF) investigational device exemption study using the company's Arctic Front catheter to treat atrial fibrillation (AF). The data were presented at the International Boston Atrial Fibrillation Symposium. Packer reported data on two sets of Arctic Front patient data. He reviewed the 12-month data from the original 20 patient European trial which saw 84% of patients AF-free (a further 10% had significant reductions in AF burden and have conditions that do not warrant re-treatment and are considered clinically successful). Secondly, he reported on early data from 15 patients treated in the feasibility stage of the STOP AF trial who have now reached a minimum three-month follow up point. Thirteen patients are now AF-free (87%), one has been retreated, and one other scheduled to be retreated (one retreatment is consistent with the study's protocol). There were no reported permanent serious device-related adverse events.

• Exact Sciences (Marlborough, Massachusetts) said that improvements to its technology demonstrated sensitivity in excess of 80% for detecting colorectal cancer in a recent research study. The blinded study was designed to test the efficacy of technological advances to enhance colorectal cancer detection in stool. The study results have been submitted for presentation at the major annual meeting of gastroenterologists, Digestive Disease Week, which will be held in May. The results also are being submitted for publication. Exact Sciences uses applied genomics to develop effective, patient-friendly screening technologies for use in the detection of cancer. Certain of Exact Sciences technologies are being offered in a commercial testing service, PreGen-Plus, developed by Laboratory Corp. of America Holdings (Burlington, North Carolina). PreGen-Plus is used for screening for colorectal cancer in the average-risk population.

• Halozyme Therapeutics (San Diego), focused on the development of recombinant human enzymes, reported that it has completed enrollment of a clinical trial of subcutaneous hydration (hypodermoclysis) with Hylenex. Hy-lenex is a liquid injectable formulation that includes the active pharmaceutical ingredient, recombinant human hyaluronidase (rHuPH20), FDA-approved for use as a spreading agent to increase the absorption and dispersion of other injected drugs. The INFUSE-LR (INcreased Flow Utilizing Subcutaneously-Enabled Lactated Ringer's) trial is designed to determine the subcutaneous infusion flow rate of lactated Ringer's solution with and without Hylenex, assess the subcutaneous infusion flow rate dose response to Hylenex over one order of magnitude of dose, and assess safety and tolerability. Lactated Ringer's solution is a widely used fluid for intravenous rehydration. The double-blind, randomized, placebo-controlled, dose-comparison study reached its target enrollment of 50 evaluable subjects. Results are expected to be presented at the 2006 American Academy of Hospice and Palliative Medicine's meeting in Nashville, Tennessee, next month.

• SenoRx (Aliso Viejo, California) said a study presented at the 2005 American Society of Breast Surgeons meeting in Los Angeles retrospectively analyzed the experience of 45 general surgeons in a variety of practice settings using the SenoRx Gel Mark Ultra biopsy site marking system. The paper concluded that “the Gel Mark Ultra biopsy site marking system is a new biopsy site localization device that provides a safe and effective alternative to traditional localization methods. More importantly, it provides a significant reduction in the frequency of positive margins as well as enhancing surgical efficiency and patient comfort.“

• Siemens Medical Solutions (Malvern, Pennsylvania) reported the general availability of Soarian Community Access, an information technology solution that enables healthcare providers to securely connect with patients and other members of the healthcare community online. The latest addition to the Soarian family, the Web-native solution provides secure, single sign-on access to browser and non-browser-based applications, web content, online services and content created by a health enterprise. It also features a web-based messaging system for secure communications and information exchange between hospitals, physician providers, ancillary providers and patients. The solution is currently live at St. Luke's Health System (Boise, Idaho), a 369-bed tertiary care, and Northwest Physicians Network (Tacoma, Washington), a 424-member independent physician association.

• Vertebron (Stratford, Connecticut) reported one year of successful clinical history with the Semi-Constrained Cervical Plate System (SCP), its second system release, with more than a few hundred surgeries to date. With its proprietary integrated self-locking mechanism and QuickDrive instrumentation, surgical technique and procedural time is minimized. Building on the success of the SCP system, the company has since released the Small Stature Cervical Plate System, which uses the same instrumentation and locking mechanism.

• Vidacare (San Antonio), manufacturer of the EZ-IO solution for immediate vascular access when conventional IV access is challenging or impossible, has received 510(k) clearance from the FDA to market the EZ-IO product system for use in pediatrics. Vidacare defines pediatrics (PD) as patients weighing between 3 kg and 39 kg and adult (AD) as patients weighing 40 kg or greater, rather than by age. The EZ-IO product system, which allows intraosseous access through the bone marrow cavity, provides a viable alternative to traditional intravenous access, which often is difficult to gain in pediatric patients whose veins have collapsed because of trauma or dehydration. The EZ-IO AD has been in use by emergency medical systems and hospitals across the U.S. since its market introduction in late 2004.

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