Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for a suite of products deemed safe for use in a magnetic resonance imaging (MRI) environment. The ImageReady™ MR-Conditional Pacing System, which includes ACCOLADE™ MRI and ESSENTIO™ MRI pacemakers, as well as the new INGEVITY™ MRI pacing leads, is designed to treat bradycardia, a condition in which the heart beats too slowly. Patients implanted with the full system are able to receive full-body MR scans in 1.5 Tesla environments when conditions of use are met.
The newly-approved family of INGEVITY MRI pacing leads includes active and passive fixation models. This marks the first time a passive fixation pacing lead is approved for U.S. patients undergoing MR scans.
Approval of the INGEVITY MRI leads, as well as the full ImageReady System, was based on data from two global clinical trials. The INGEVITY trial, a prospective, non-randomized study, enrolled 1,036 patients and assessed safety, performance and effectiveness of the leads in patients with a single or dual chamber pacemaker. The SAMURAI trial, a prospective, randomized study, enrolled 351 patients and evaluated safety and effectiveness of the ImageReady System for use in patients with a single or dual chamber pacemaker when used in an MRI environment.
The ImageReady System offers automatic daily monitoring via the LATITUDE™ NXT Patient Management System. An increasingly important tool for physicians, automatic daily monitoring has been shown to improve survival in patients with pacemakers1. The LATITUDE NXT wireless system allows for earlier intervention and improved patient outcomes by providing physicians with device and patient information through customizable alerts.
Profound Medical announced that the company has received CE Mark approval for the commercial sale of TULSA-PRO.
“Our innovation and passion for this unique therapy has been recognized with the achievement of CE Mark. This is a major step forward in the growth of the company, facilitating the commercial launch of TULSA-PRO in Europe and other CE Mark jurisdictions. We expect this approval to be a catalyst for the adoption of our therapy, which has the potential to make a significant impact on the clinical community and, ultimately, patients being treated with TULSA-PRO,” said Steve Plymale, CEO.
Profound’s novel technology combines real-time Magnetic Resonance (MR) imaging with transurethral robotically-driven ultrasound and closed-loop thermal feedback control, providing a highly precise treatment tailored to patient-specific anatomy and pathology.TULSA-PRO has demonstrated accurate and precise ablation of prostate tissue, both malignant and benign, while providing a favourable safety profile and a low rate of erectile dysfunction.
Profound Medical GmbH, a subsidiary of Profound Medical Corp., has been established in Hamburg, Germany to support European commercial operations. The commercial launch of TULSA-PRO in Europe and other CE Mark jurisdictions will commence immediately.
Inscopix has brought its nVista brain imaging platform—which can view upwards of 1000 neurons simultaneously in one field of view—to market. Originally only accessible through the Neuroscience Early Access Program (NEAP), Inscopix plans to expand the system’s reach to the widest spectrum of neuroscience investigators through packages customized for specific researcher needs.
Centered on a patented miniature microscope technology from Stanford University (California), the nVista system can decode the neural language underlying brain function and behavior. With the microscope, a tiny fluorescence camera can be implanted in hard-to-reach areas of a freely moving animal’s brain and record millisecond-by-millisecond movies of the activity of large neural networks over days or several months.
Since the launch of NEAP in 2012, Inscopix disseminated nVista to over 100 early-adopter labs that played a crucial role in maturing the platform through feedback and scientific validation for its incorporation into standard neuroscience practice. NEAP researchers have published close to 20 research articles with the system in journals such as Neuron,Nature, and Cell, that provided deeper insights into multiple aspects of brain function, including motivation, learning and memory, and goal-directed behaviors. nVista also led to Inscopix’s recognition by the World Economic Forum as a “Technology Pioneer” in 2015.
Product information can be found from Inscopix website by clicking here.
Core symptoms of anorexia nervosa, including the urge to restrict food intake and feeling fat, are reduced after just one session of a non-invasive brain stimulation technique, according to King’s College London Research.
This new study is the first randomised control trial to assess whether repetitive transcranial stimulation (rTMS), already an approved treatment for depression, is also effective in reducing symptoms of anorexia.
Up to 20 per cent of people with anorexia die prematurely from the disorder and treatments in adults are moderately effective, with only 20-30 per cent of people recovering from the best available talking therapies.
Given the urgent need to improve treatments, researchers are increasingly looking towards emerging neuroscience-based technologies that could target the underlying neural basis of anorexia.
In the study, 49 people completed food exposure and decision-making tasks, both before and after a session of either real or placebo rTMS. Symptoms of anorexia were measured immediately prior to and following rTMS, as well as 20 minutes and 24 hours after the session.
This study represents independent research part-funded by the National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at South London and Maudsley NHS Foundation Trust and King’s College London.