• Andante Medical Devices (Omer, Israel) reported the first release of SmartStep in the Israeli market. The FDA-cleared SmartStep is a portable biofeedback device developed to improve gait during rehabilitation. The SmartStep is used for daily therapeutic exercise to improve weight bearing, increase treatment compliance and facilitate improvement in the quality of gait for patients recovering disorders affecting the lower limb.

• Advanced Neuromodulation Systems (Dallas) reported an expanded U.S. market launch of its new flagship rechargeable implantable pulse generator (IPG) system, the Eon Neurostimulation System. The company said the Eon offers “a significant step-up in IPG capability,” including high power, longer recharge intervals, broad programming capability and systems configuration flexibility. The Eon IPG can also power up to 16 independent electrodes in a dual eight-electrode lead configuration, similar to the company’s flagship Renew radio frequency external power system. Easy to implant, the Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs.

Applied Biosystems (Foster City, California), a business of Applera, reported the release of a new version of its freely available SNPbrowser Software tool. Designed to simplify the selection of single nucleotide polymorphism (SNPs) assays for disease association studies, the latest version of SNPbrowser Software incorporates about 1 million SNPs from the first phase of the International HapMap Project. The software, available at www.allsnps.com/snpbrowser, provides a comprehensive database of more than 5 million SNP assays compatible with Applied Biosystems genotyping platforms, as well as numerous annotations and selection criteria useful for the design of disease association studies. The company said specific SNPbrowser enhancements include the ability to immediately identify optimal subsets of SNPs that are available as Applied Biosystems TaqMan SNP Genotyping Assays or that can be used in the SNPlex Genotyping System; easily select from the most extensive collection of putative functional coding SNPs; examine both HapMap and Applied Biosystems validated SNP maps and derived patterns of genetic variation; and export annotations and genotypes for subsets of validated SNPs, from either the HapMap Project or Applied Biosystems data sets, for use in other analyses.

• BioArray Solutions (Warren, New Jersey), a molecular diagnostics company, reported the FDA 510(k) clearance of a new immunoassay for the simultaneous detection of six antibodies to different extractable nuclear antigens (ENA). The ENA IgG BeadChip Test System, for use on the company’s Array Imaging System (AIS 400), uses BioArray Solutions’ BeadChip format to simultaneously detect multiple analytes of interest on a tiny silicon chip holding a planar array of color encoded microparticles. The AIS 400 fully automates image acquisition and integrated analysis to rapidly generate assay results.

• CryoCath Technologies (Montreal), a maker of cryotherapy products to treat cardiovascular disease, said the first patient was treated in its Cryo System Trial Of Paroxysmal Atrial Fibrillation (STOP AF), an investigational device exemption trial using the company’s Arctic Front catheter for atrial fibrillation (AF). Dr. Douglas Packer, of the Mayo Clinic (Rochester, Minnesota), the principal investigator of this study, performed the successful procedure, with all four pulmonary veins electrically isolated using only the Arctic Front catheter. Three of the four veins were electrically isolated with one lesion application. The patient was diagnosed with AF several years ago and anti-arrhythmic medications have failed to control his condition, the company said. STOP AF will initially treat about 20 AF patients at two U.S. centers in support of the next larger pivotal stage. Initial three-month follow-up data on the first set of patients is expected to be available in 4Q05. The study will see the use of two CryoCath catheters, Arctic Front to treat AF and Freezor MAX to treat atrial flutter when concomitant to AF and to touch up gaps when the Arctic Front cannot fully isolate the veins.

• DiaDexus (South San Francisco, California) said that the FDA has granted the company marketing clearance for the PLAC test, making it the first blood test to aid in predicting risk for ischemic stroke associated with atherosclerosis (Medical Device Daily, March 9, 2005). The PLAC test measures an enzyme in the blood called lipoprotein-associated phospholipase A2 (Lp-PLA2). Because Lp-PLA2 and systolic blood pressure levels are additive in their ability to predict stroke risk, the PLAC test can help identify stroke-prone hypertensive patients.

• ELA Medical (Le Plessis Robinson, France), a Sorin Group company and manufacturer of cardiac rhythm management implantable and diagnostic systems, reported the first clinical implants of Ovatio DR, its new dual-chamber implantable cardiac defibrillator (ICD), which features the AAIsafeR 2 pacing mode. ELA’s AAIsafeR 2 mode promotes the patient’s intrinsic conduction by limiting unnecessary pacing to the ventricle to 0.1% in patients who have normal heart conduction. The first Ovatio DR device was implanted June 7 by cardiologist Dr. Johannes Sperzel at the Kerckhoff-Klinik (Bad Nauheim, Germany). The patient was a 51-year-old male with a history of myocardial infarction due to coronary artery disease who experienced episodes of polymorphic ventricular tachycardia. The patient also suffers from sick sinus syndrome, leading to symptomatic bradycardia while his intrinsic atrio-ventricular conduction is normal. Another implant of an Ovatio DR took place in the UK on June 10. The company said the rollout of the complete Ovatio ICD family is expected in 4Q05 together with ELA’s new generation of defibrillation leads.

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