US FDA best practices for initiating early feasibility studies for neurological devices in the United States.

This article describes the efforts of the US Food and Drug Administration (FDA) Office of Neurological and Physical Medicine Devices to facilitate early clinical testing of potentially beneficial neurological devices in the US. Over the past 5 years, the FDA has made significant advances to this aim by developing early feasibility study best practices and encouraging developers and innovators to initiate their clinical studies in the US. The FDA uses several regulatory approaches to help start neurological device clinical studies, such as early engagement with sponsors and developers, in-depth interaction during the FDA review phase of a regulatory submission, and provision of an FDA toolkit that reviewers can apply to the most challenging submissions.

FDA Regulation of Neurological and Physical Medicine Devices: Access to Safe and Effective Neurotechnologies for All Americans.

The United States Food and Drug Administration (FDA) ensures that patients in the U.S. have access to safe and effective medical devices.

Shift from cytoplasmic to nuclear maspin expression correlates with shorter overall survival in node-negative colorectal cancer.

Maspin has been characterized as a potent tumor suppressor in many in vitro and in vivo studies. In contrast, in stage III colon cancer, an association with shorter overall survival as well as sensitivity to chemotherapy was found for cases with nuclear maspin expression. Because 20% of node-negative colorectal cancer cases show a fatal clinical course, we hypothesized that immunohistochemical maspin expression could be of help to identify higher-risk cases.

Shape is not associated with the origin of pericolonic tumor deposits.

Pericolonic tumor deposits (PTDs) are associated with an adverse outcome in colorectal cancer. According to the International Union Against Cancer they are classified as N1 or V1/V2 depending on their shape. This recommendation, however, is not well supported by the literature.

Technical development and initial animal experience with a novel, uncovered, self-expanding, highly flexible aortic stent with improved side branch access.

Purpose: To present a novel, uncovered, self-expanding aortic stent for use as a thoracoabdominal stent-graft extension to improve distal flow in aortic dissections complicated by malperfusion syndrome and to enhance the remodeling process in the abdominal aorta after thoracic endovascular aortic repair.

Methods: This aortic prosthesis is a laser cut, self-expanding nitinol stent that is designed to provide an optimal balance between radial support and flexibility to negotiate tortuous arterial anatomy. Undulating circumferential rings provide radial force, while flexibility is achieved through the shape and configuration of the longitudinal connectors that extend from the valley of one ring to the offset peak of the next ring.

[Fitness Check for elder drivers].

There is no compulsory and regular medical/psychological checkup for elderly drivers in Germany. In the near future, a growing danger to traffic safety is expected because of the increasing percentage of elderly people and increasing prevalence of geriatric diseases. To close this safety gap, TUV SUD Life Service GmbH has put into practice a voluntary consulting concept for elderly drivers (Fitness Check).

Cytostatic activity of paclitaxel in coronary artery smooth muscle cells is mediated through transient mitotic arrest followed by permanent post-mitotic arrest: comparison with cancer cells.

The anti-cancer agent paclitaxel (PTX) is an effective anti-restenosis agent on drug eluting stents, primarily due to growth inhibition of coronary artery smooth muscle cells (CASMC) across a wide dose range. In this study, we compared the effects of PTX on CASMC to apoptotic-prone HL60 leukemia cells and apoptotic-reluctant A549 lung cancer cells to assess cell survival mechanisms. In comparison to HL60 and A549 cells, CASMC had a shorter mitotic arrest and a lower mitotic index.

Comparative effects of paclitaxel and rapamycin on smooth muscle migration and survival: role of AKT-dependent signaling.

Objective: Advances in stent technology have enabled the delivery of drugs to improve outcomes after stent deployment. However, the optimal payloads for stents are not clear, and the appropriate stent-based therapies for high-risk patients, such as diabetics, have not been clearly established.

Methods And Results: We used smooth muscle cell culture models to compare the activities of rapamycin and paclitaxel.

Paclitaxel induces primary and postmitotic G1 arrest in human arterial smooth muscle cells.

Paclitaxel (PTX), a microtubule-active drug, causes mitotic arrest leading to apoptosis in certain tumor cell lines. Here we investigated the effects of PTX on human arterial smooth muscle cell (SMC) cells. In SMC, PTX caused both (a) primary arrest in G(1) and (b) post-mitotic arrest in G(1).