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December 5, 2016


Roche and Good Start Genetics Announce Marketing Agreement


Good Start Genetics announced that it has entered into a collaborative agreement with Roche Holding AG, in which Roche will begin selling Good Start Genetic’s GeneVu laboratory developed screening test in combination with its proprietary Harmony non-invasive prenatal test in the United States. While Harmony specifically detects Down syndrome, Edward syndrome and Patau syndrome, GeneVu offers an array of additional tests that patients and physicians may choose from, including ethnicity-specific tests for blood disorders. This agreement will therefore enable Roche to offer a more complete range of screening services to healthcare professionals and patients across the United States, and also enhance Good Start Genetic’s reputation in the market.


See more on the GeneVu and Harmony tests on Meddevicetracker.


December 6, 2016


Medtronic’s Endurant II/IIs Stent Graft System Receives CE Mark


Medtronic announced that is has obtained CE Mark approval for the Endurant II/IIs stent graft system to treat abdominal aortic aneurysm (AAA) patients using a ChEVAR procedure, a parallel graft chimney technique that uses commercially available balloon expandable covered stents combined with a standard aortic stent graft. This expanded indication in the European Union will enable the Endurant II/IIs stent graft system to be used in patients with complex aneurysms with short aortic neck lengths ≥2 mm, expanded from the prior neck length indication ≥10 mm. Prior research has demonstrated that standardized use of the Endurant II/IIs stent graft system with ChEVAR in 128 patients is associated with 100 percent technical success, statistically significant aneurysm sac regression (p = .001), 95.7 percent primary patency of the chimney grafts, and a low incidence of chimney related reinterventions. This expanded approval will at first be commercialized in Europe, and then into additional countries recognizing the CE Mark.


See more on the Endurant II on Meddevicetracker.


December 7, 2016


Abiomed Impella CP Receives Expanded FDA Approval


Abiomed announced it has expanded its U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for Impella heart pump use in high-risk percutaneous coronary interventions (PCI) to include the Impella CP heart pump. The Impella CP heart pump was previously cleared in April 2016 for treatment of ongoing cardiogenic shock; however, recent data from Abiomed’s Protect I and Protect II clinical studies has demonstrated that use of the Impella CP in high-risk PCI procedures significantly enhances clinical outcomes. In lieu of this expanded indication, the Impella CP joins the Imepella 2.5 as the only hemodynamic support devices proven safe and effective by the FDA for high-risk PCI and Acute Myocardial Infarction (AMI) cardiogenic shock.


See more on the Impella CP on Meddevicetracker.


December 8, 2016


St. Jude Medical Receives CE Mark


St. Jude Medical has obtained CE Mark approval for full-body magnetic resonance (MR) conditional labeling of the Proclaim Elite Spinal System, which had previously been cleared for MRI scanning of only the head and extremity areas. This prior restriction in labelling was considered a significant barrier to patients who sought relief for chronic pain by implantation of the Proclaim Elite, because it imposed a limitation to their diagnostic testing options. However, with this approval, in combination with a similar approval recently granted by the United States FDA, the limitations to diagnostic testing for these patients has been significantly mitigated. Patients who have received implantation of the Proclaim Elite SCS System may now undergo comprehensive MRI diagnostic testing while also retaining access to the medical treatment they need.


See more on the Proclaim Elite on Meddevicetracker.






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