San Diego-based Astute Medical Inc. received FDA 510(k) clearance for improvements to the Nephrocheck test kit that will extend the shelf life for the test to 12 months when refrigerated. The Nephrocheck test is used to help determine if certain hospitalized patients are at risk of developing moderate to severe acute kidney injury (AKI) in the 12 hours following test administration. Early knowledge that a patient is likely to develop AKI may prompt closer patient surveillance and help prevent permanent kidney damage or death. Astute expects to make the product with extended shelf life available to customers later this year. The contents and formulations of the test kit have not changed.
Medtronic plc., of Dublin, and the University of Texas Health Science Center at Houston (UTHealth) have enrolled the first patient in a clinical study assessing the Medtronic Valiant Evo thoracic stent graft system for the minimally invasive repair of descending thoracic aortic aneurysms (TAA). The international, multicenter, prospective study will include 100 patients in the U.S. and Europe. The news was reported at the 2016 Vascular Annual Meeting of the Society for Vascular Surgery in National Harbor, Md. Ali Azizzadeh, professor and chief of division of Vascular and Endovascular Surgery in the department of Cardiothoracic and Vascular Surgery at McGovern Medical School at UTHealth, is the U.S. principal investigator for the trial and performed the first procedure on a patient with a descending TAA. Azizzadeh reported the first patient treated in the investigational device exemption trial is an 88-year-old male who is doing well post-treatment. Medtronic also reported its Micra transcatheter pacing system (TPS) was successfully implanted in nearly all patients in the trial – 99.2 percent – and met its safety and effectiveness endpoints with wide margins. These data, from the Medtronic Micra TPS global clinical trial, were presented during a late-breaking special report session at the 2015 American Heart Association Scientific Sessions and simultaneously published in the New England Journal of Medicine. The presentation included a comparison of Micra TPS safety performance to a pre-defined, historical control group consisting of more than 2,500 patients from six studies of commercially available, conventional pacing systems. Compared to patients with conventional systems, the patients in the Micra trial were older and had more comorbidities, yet had fewer major complications. Almost all patients in the trial, 98.3 percent (292 of 297), had low and stable pacing thresholds at six months, yielding projected average longevity for the device of more than 12 years (300 patients at six months). In addition, the low major complication rates experienced by Micra patients resulted in significant reductions in health care utilization compared to conventional pacing systems: Micra patients had 54 percent fewer hospitalizations (p=0.011) and 87 percent fewer system revisions (p<0.001) than observed in the historical control group. The trial enrolled 744 patients; it is ongoing and will continue to evaluate the safety and efficacy of the device through a single-arm, multi-center study at 56 centers in 19 countries. Primary endpoints of the trial were freedom from device-related or procedure-related major complications with target performance of >90 percent (lower CI >83 percent) at six months, and low and stable pacing thresholds as demonstrated by <= 2V and no increase of >1.5V (relative to implant) and target performance of >89 percent (lower CI >80 percent) in the first 300 patients at six months.
Paris-based Stentys received a CE mark for the longest version of its Xposition S Sirolimus-eluting self-apposing stent. The Xposition stent portfolio already included three lengths (17 mm, 22 mm and 27 mm), and this 37 mm drug-eluting stent is particularly well-suited to the treatment of lesions in the left main coronary artery and in tapered vessels. Cardiologists now only need to implant a single self-apposing stent rather than a long conventional stent, thus minimizing the risk of malapposition and related complications.