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May 29, 2017

Mente Autism Trial Nearing Completion


Neurotech announced that the clinical trial for Mente Autism has progressed as planned with investigators now approaching the end of the 12-week therapy session for the initial cohort of subjects. The trial, which is being independently conducted by the Carrick Institute in Orlando, Florida, aims to investigate Mente Autism as a therapy for children aged between 3 and 12 years on the autism spectrum. Subjects with diagnosed Autism Spectrum Disorder from throughout the United States have been randomized into a treatment group and a sham group. Subjects are being progressively onboarded to Mente Autism to commence 12 weeks of at-home therapy, and the initial subjects will start to conclude the therapy shortly.


The Mente Autism system records brainwave levels in real time. Mente Autism is a neurofeedback system for safe home use by children with Autism Spectrum Disorder (ASD). Excessive delta and theta have been recorded in children with ASD. The Mente Autism focuses on reducing delta and theta levels recorded from these channels through neurofeedback in the form of auditory stimulation.


See more information on Mente Autism on Meddevicetracker.



Gruppo Bioimpianti Announces First Implants of K-MOD REV Knee Prosthesis



Gruppo Bioimpianti announced that Dr. Pietro Cavaliere and his surgical team performed the first two implants of Cemented K-MOD REV Tibial Component.


Since the first use, the complete K-MOD REV System has demonstrated its modularity with the K-MOD PRIMARY System. In both cases presented, it has been implanted to solve problems at the tibial level. The K-MOD system’s full modularity, allows the surgeon to tackle a wide range of situations in which the goals are minimum invasiveness and bone sparing, correct alignment, extension and flexion gap balancing, knee biomechanical restoration.


K-MOD is a modular total primary knee system designed to minimize complications such as wear, instability and the risk of patellar dislocation.


See more information on K-MOD on Meddevicetracker.



May 30, 2017

First Two Patients Successfully Treated with CGuard EPS


InspireMD announced the first two patients in Hong Kong have been successfully treated with CGuard Embolic Protection System (EPS). The two cases were conducted on patients with carotid artery stenosis at St. Teresa Hospital by Dr. PW Cheng and Dr. YW Chow, a leading neurointerventional radiologist and leading cardiologist, respectively.


The CGuard embolic protection system (EPS) is targeting carotid embolism protection to treat carotid artery disease. CGuard EPS used the same MicroNet technology featured on the MGUARD and MGUARD Prime coronary embolic protection systems. The MicroNet technology is a single fiber knitted mesh wrapped on an open cell stent platform designed to trap debris that can dislodge and travel downstream after a patient is treated with traditional stenting methods. The technology seeks to protect patients from plaque debris and blood clots breaking off and which can lead to life threatening strokes.


See more information on CGuard Embolic Protection System on Meddevicetracker.



May 31, 2017

SpaceOAR System Receives Approval in Japan



Augmenix announced that it has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market its SpaceOAR System in Japan. SpaceOAR hydrogel is an absorbable prostate-rectum spacer that reduces rectal injury during prostate radiotherapy.


SpaceOAR System is a polyethylene glycol (PEG) hydrogel that upon injection creates a space that temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate cancer with the intent to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR System consists of components for the preparation of a synthetic, absorbable hydrogel spacer and a delivery mechanism provided in a sterile, single use package. Once assembled, the Y-connector allows for hydrogel injection via an 18 gauge needle. The spacer is formed by mixing two solutions, the Precursor and the Accelerator. The Precursor solution is formed through the mixing of the Diluent solution (Trilysine buffer solution) with the PEG powder. The Accelerator solution is a salt buffer solution. The hydrogel spacer maintains space for approximately 3 months and is then gradually liquefied via hydrolysis; it is absorbed and cleared via renal filtration in approximately 6 months of implantation.


See more information on SpaceOAR System on Meddevicetracker.



Avinger Announces 24-Month Results from Pivotal VISION Study



The VISION study was designed to evaluate the safety and effectiveness of Avinger’s Pantheris system to perform directional atherectomy while, for the first time ever, allowing physicians to use real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries. Data from the study, which demonstrated successful achievement of all primary and secondary safety and effectiveness endpoints, supported U.S. Food and Drug Administration (FDA) 510(k) clearance of the system in 2016.


Twenty four (24) month follow-up results from 89 patients were presented. Key highlights of the presentation include:


  • Kaplan Meier survival probability measured 82% freedom from target lesion revascularization (TLR) at 12 months by patient (84% by lesion) and 74% freedom from TLR at 24 months by patient (76% by lesion)

  • The VISION 24-month Kaplan Meier freedom from target lesion vascularization at 24 months remained stable between 18 and 24 months

  • Statistically significant improvements in ankle brachial index (ABI) and Rutherford classification at 30 days were maintained through 24 months

  • A majority of lesions were treated using standalone optical coherence tomography (OCT) guided atherectomy with the Pantheris catheter, with only 9.6% (n=19/198) receiving adjunctive drug coated balloon (DCB) therapy and only 5% (n=10/198) receiving adjunctive stent therapy


See more information on Pantheris on Meddevicetracker.



June 1, 2017

Singulex Receives CE Mark for first Ultra-Sensitive Cardiac Troponin Test


Singulex announced it has applied the CE Mark to its ultra-sensitive troponin I assay (cTnl), the first offered on the Sgx Clarity system, a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology.


The Singulex Sgx Clarity cTnl Assay quantitatively measures the biomarker troponin at levels far lower than existing technologies. The Sgx Clarity cTnl Assay is indicated to be used in conjunction with clinical evaluation for ruling out cardiac ischemia in patients suspected of having coronary artery disease (CAD). Efficient rule-out helps avoid the costs and adverse effects of additional expensive and potential unnecessary testing, such as stress tests, and allows clinicians to focus resources on the sickest patients.


See more information on Cardiac Troponin I Assay on Meddevicetracker.


Ra Medical Announces First Commercial Use of DARBA System



Ra Medical Systems announced the commercial launch in the United States of the DABRA (Destruction of Arteriosclerotic Blockages by laser Radiation Ablation) System for the treatment of Peripheral Artery Disease. This follows FDA clearance earlier this week. Dr. Athar Ansari of the California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient, performing the first DABRA case on arterial blockages via brachial artery access.


DABRA Catheter is a single-use catheter that tracks the true lumen without a guidewire and tends not to go subintimal. It is a full catheter tip forward cutter, delivering ablation of all types of plaque, without the “dead-space” of fiber optic bundle catheters. It produces a lumen while minimizing trauma to the vasculature. DABRA Catheters have been used with introducers, sheaths, and guide catheters, operated ipsilateral and contralateral, and antegrade and retrograde.


The DABRA Laser is the excimer laser power source for DABRA Catheters. It produces 308-nm UVB photons which photochemically ablate arterial blockages, reducing calcium, thrombus, and atheroma into their fundamental chemistry, minimizing downstream debris. The laser is small enough for any cath lab, weighs about 100 lbs (48 kgs), and is portable around and between rooms. It plugs into a standard outlet and is ready to treat in 4 minutes.


See more information on DARBA on Meddevicetracker.

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