• Aastrom Biosciences (Ann Arbor, Michigan) reported that its U.S. clinical trial of its Tissue Repair Cell (TRC) product — a mix of bone marrow stem and progenitor cells — intended for the treatment of long-bone, severe fractures has successfully achieved the first FDA-required clinical benchmark, meeting the clinical safety endpoint for this product when used in bone graft indications. The company is now able to expand the multi-center trial to include a broader range of fracture indications, with an investigational new device approval to treat appendicular, or fresh, non-union fractures. Aastrom's bone graft TRC product also is in clinical trials in Barcelona, Spain, and Bochum, Germany, and in a clinical trial in Barcelona for the use of TRCs in sinus lift procedures.

• Biotronik (Lake Oswego, Oregon), a manufacturer of cardiovascular products, reported the first worldwide implantation of a Philos II DR-T pacemaker and a Lexos DR-T ICD with Home Monitoring Early Detection technology. The advanced Home Monitoring technology integrates wireless, cellular phone and standard phone technology for what the company called “unsurpassed“ mobility and coverage. The cardiac devices allow physicians to remotely and automatically monitor their heart patients anytime, anywhere. The implantations were performed at the Yakima Heart Center (Yakima, Washington) and Parkwest Medical Center (Knoxville, Tennessee).

• MedicalCV (Minneapolis), a cardiovascular surgery device manufacturer, reported the completion of the first U.S. human clinical case using the AtriLaze surgical ablation system. The diode laser system allows the cardiovascular surgeon to deliver laser energy to atrial tissue creating “exact and complete lines of cardiac tissue ablation,“ according to the company. Carmelo Otero, MD, a cardiothoracic and vascular surgeon, performed the first U.S. clinical case at Christus Santa Rosa Hospital (San Antonio). The AtriLaze surgical ablation procedure was performed as a concomitant procedure with mitral valve replacement and tricuspid valve repair. Use of the AtriLaze system added a minimal amount of time to the overall surgical procedure, the company noted. MedicalCV is currently marketing the AtriLaze system via a direct U.S. sales force for clinical use and is focusing its resources on the minimally invasive treatment of atrial fibrillation as a stand-alone procedure.

• Nanosphere (Northbrook, Illinois) reported the benefits of its technology for the medical analysis of human DNA. Nanosphere's nanoparticle-based technology allows for rapid, highly sensitive and specific single nucleotide polymorphism (SNP) genotyping. The technology, reported on in the February issue of Nucleic Acids Research, allows detection of a SNP in an unknown genotype with a greater than 99% confidence threshold and can be used with human DNA obtained from samples as small as a drop of blood. The technology eliminates the need for costly, time and labor-intensive gene amplification or enzymatic interventions.

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