Reduction in incomplete stent apposition area caused by jailed struts after single stenting at left main bifurcation lesions: micro-CT analysis using a three-dimensional elastic bifurcated coronary artery model.

Stent struts protruding into ostial side branch called "jailed strut" at bifurcation lesions is a likely cause of thrombus formation. We aimed to investigate the influences of multiple kissing balloon inflation (KBI) for stent expansion, and stent platform design, respectively, on the reduction of incomplete stent apposition area (ISA area) caused by jailed struts at a side-branch ostium, using a three-dimensional elastic left main (LM) bifurcated coronary artery model. The referenced LM bifurcation angle data of 209 patients were stratified by tertiles focusing on the angle between the LM trunk (LMT) and left anterior descending artery (LAD).

Compassionate use of drugs and medical devices in the United States, the European Union and Japan.

Compassionate use, also called expanded access, provides an important pathway for patients with life-threatening conditions to gain access to unapproved investigational drugs, biologics and medical devices. Although the United States (US) and the countries of the Europe Union (EU) have mechanisms that are associated with the use of unapproved products, as of May 2015 there was no such mechanism in Japan. Instead, unapproved products are used under a physician's discretion in conjunction with the Japan Medical Practitioners' Act or Advanced Medical Care B.

Cost-Effectiveness Analysis of Deep Brain Stimulation in Patients with Parkinson's Disease in Japan.

Objective: Deep brain stimulation (DBS) is an effective surgical option for treating Parkinson's disease (PD). DBS is invasive, with a high initial cost. In Japan, questions have been raised about its cost-effectiveness and the resulting improvements in outcome.

Non-clinical assessment design of autologous chondrocyte implantation products.

The aims of this study were to investigate the premarket assessment of autologous chondrocyte implantation (ACI) products especially regarding the non-clinical assessment by surveying the guidelines and review reports of authorized ACI products in detail and to provide information regarding the non-clinical assessment of the safety and efficacy for the future development of regenerative medicine products to design effective premarket assessment. The non-clinical assessment plays a role in justifying the testing of investigational products in humans. Effective non-clinical assessments minimize the risk of clinical trials and achieve prompt product development.

Re-examination of regulatory opinions in Europe: possible contribution for the approval of the first gene therapy product Glybera.

The first commercially approved human gene therapy in the Western world is Glybera (alipogene tiparvovec), which is an adenoassociated viral vector encoding the lipoprotein lipase gene. Glybera was recommended for marketing authorization by the European Medicines Agency in 2012. The European Medicines Agency had only ever reviewed three marketing authorization applications for gene therapy medicinal products.

Approaches to improve development methods for therapeutic cancer vaccines.

Therapeutic cancer vaccines are an immunotherapy that amplify or induce an active immune response against tumors. Notably, limitations in the methodology for existing anti-cancer drugs may subsist while applying them to cancer vaccine therapy. A retrospective analysis was performed using information obtained from ClinicalTrials.

Regulatory approval for autologous human cells and tissue products in the United States, the European Union, and Japan.

Human cells and tissue products belong to a relatively new class of medical products. Therefore, limited information is available on the classification and premarket evaluation of human cells and tissue products in the United States (US), the European Union (EU), and Japan. In this study, the definition, legislation, and approval system of these products were surveyed.

Real-time, noninvasive optical coherence tomography of cross-sectional living cell-sheets in vitro and in vivo.

Cell sheet technology has a history of application in regenerating various tissues, having successfully completed several clinical trials using autologous cell sheets. Tomographic analysis of living cell sheets is an important tool in the field of cell sheet-based regenerative medicine and tissue engineering to analyze the inner structure of layered living cells. Optical coherence tomography (OCT) is commonly used in ophthalmology to noninvasively analyze cross-sections of target tissues at high resolution.

Approval Status and Regulatory Actions for Radiopharmaceuticals in the United States and Japan.

The aim of this study was to identify the differences between Japan and the United States in the approval status and regulatory actions for radiopharmaceuticals. The package inserts of radiopharmaceuticals that have been approved in the United States and Japan were used to investigate the status of approval in each country, examining the similarities and differences thereof and taking the regulatory systems of the 2 countries into account. Results revealed that since 1995, fewer products have been approved in Japan than in the United States: 16 radiopharmaceuticals have been approved in the United States, compared to only 7 in Japan.

Ex vivo evaluation of high-intensity focused ultrasound with ultrasonic-induced cavitation bubbles.

Purpose: In high-intensity focused ultrasound (HIFU) comprising high-intensity burst ultrasound (triggering pulse) and medium-intensity continuous wave ultrasound (heating wave), optimizing the effects of the triggering pulse conditions on the coagulated volume may help to reduce treatment times.

Methods: HIFU combined with a triggering pulse was applied to chicken deep pectoral muscles. The acoustic power of the heating wave was set to 36, 54, or 72 W.

A meta-analysis of remote patient monitoring for chronic heart failure patients.

We carried out a meta analysis of remote patient monitoring (RPM) for chronic heart failure (CHF) patients. A literature search was used to identify randomised controlled trials with more than 40 patients, published between February 2003 and February 2013. The primary outcome (mortality) was analysed using a random effect model.

Parameter-finding studies of photodynamic therapy for approval in Japan and the USA.

Objective: The purpose of this study is to investigate methods of evaluating therapeutic parameters used in the premarket evaluation of photodynamic therapy (PDT) drugs that have previously been approved in Japan and the United States, in order to establish a methodology that allows optimization of the therapeutic parameters of PDT, and to analyze current issues.

Materials And Methods: We examined the details of premarket evaluation of drug dose, drug-light intervals, as well as wavelengths, power density, and energy density of illumination sources used for the PDT drugs that have been approved in Japan the United States.

Results: There was a tendency for optimal drug dose and light energy density to be assessed in clinical studies.

Immunological monitoring of anticancer vaccines in clinical trials.

Therapeutic anticancer vaccines operate by eliciting or enhancing an immune response that specifically targets tumor-associated antigens. Although intense efforts have been made for developing clinically useful anticancer vaccines, only a few Phase III clinical trials testing this immunotherapeutic strategy have achieved their primary endpoint. Here, we report the results of a retrospective research aimed at clarifying the design of previously completed Phase II/III clinical trials testing therapeutic anticancer vaccines and at assessing the value of immunological monitoring in this setting.

Clinical evaluation of therapeutic cancer vaccines.

Therapeutic cancer vaccines are an immunotherapy that targets tumor antigens to induce an active immune response. To date, Provenge® is the only therapeutic cancer vaccine approved by the United States Food and Drug Administration. Although therapeutic cancer vaccines have not been approved by the European Medicines Agency (EMA), they have been approved in several countries other than the United States (US) and the European Union (EU).

The regulation of allogeneic human cells and tissue products as biomaterials.

The current definition of biomaterials differs vastly from it of just a decade ago. According to advancing technologies, it encompasses unpredictable materials such as engineered human cells and tissue. These biomaterials also have to be approved to use in health care business by regulatory authority, which are defined as drug, medical device, or biologics in the regulation.