ElectroCore announced 510(k) Clearance for Migraine Indication
electroCore announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an expanded label for gammaCore (nVNS), indicated as an acute treatment of pain associated with migraine in adult patients.
gammaCore therapy is a proprietary, non-invasive neuromodulation treatment delivered by a hand-held unit that stimulates the vagus nerve through the skin. This label expansion is the first for electroCore since gammaCore received its initial FDA clearance for the acute treatment of pain associated with episodic cluster headache in adult patients in April 2017. The FDA clearance of gammaCore for the acute treatment of pain associated with migraine was principally supported by the results of the multicenter, randomized, double-blind, sham-controlled trial, PRESTO (PRospectivE Study of nVNS for the Acute Treatment Of Migraine). Results from this trial, which were recently profiled at the Congress of the International Headache Society (IHC) in Vancouver in September 2017, demonstrated that treatment with gammaCore for the acute treatment of pain associated with migraine was superior to sham, and also enabled patients to reach pain freedom more frequently by 30, 60, and 120 minutes compared with sham treatment. The results further showed that a significantly higher proportion of gammaCore-treated patients achieved pain relief within two hours compared with the control treatment. Consistent with all prior studies with gammaCore, the therapy was found to be well tolerated by patients.
See more about gammaCore on Meddevicetracker.
Michael J. Fox Foundation Awards Researcher £100,000 to Enable Analysis of Data from People with Parkinson’s Disease (PD)
The Michael J. Fox Foundation (MJFF) awarded a £100,000 grant to the team led by Professor George Roussos to develop technology that records a patient’s motor symptoms of PD, including tremors, rigidity and posture instability. The grant will be used to develop a ‘software toolkit’ that will be used to analyze data, including that which is collected by Roussos’ app, cloudUPDRS.
The app was released in 2013 and is being clinically trialed at University College London Hospitals. It allows users to perform various motor functions and record their data. They can tap the screen to assess speed of movement, or hold the phone on their knees to measure tremors. This data is used to place the patient on the UPDRS (Unified Parkinson’s Disease Rating Scale), which asks patients to place themselves on numerical scales in response to questions covering their motor- and non-motor skills. The UPDRS then totals each patient’s responses to assess their severity of PD as a number.
The project aims to integrate assessment of a patient’s motor symptoms into their daily schedule, allowing measurements to be taken regularly and without intrusion but still adhering to a high clinical standard.
See more about cloudUPDRS App on Meddevicetracker
January 30, 2018
Foundation Medicine and European Organization for Research and Treatment of Cancer (EORTC) Announce Precision Medicine Collaboration
Foundation Medicine and the European Organization for Research and Treatment of Cancer (EORTC) announced a collaboration in which Foundation Medicine's comprehensive genomic profiling (CGP) tests will be used to inform patient eligibility for oncology clinical trials through the EORTC's Screening Patients for Efficient Clinical Trial Access (SPECTA) program. SPECTA is a pan-European network built by the EORTC with key institutions collaborating to provide efficient access for patients to molecularly driven clinical trials.
Under the agreement, Foundation Medicine will provide genomic testing services for the SPECTA program through three of its genomic profiling assays: FoundationOne, its flagship assay for solid tumor cancers that includes analysis of genomic biomarkers such as microsatellite instability (MSI) and tumor mutational burden (TMB), FoundationOne Heme, an assay for hematologic malignancies and sarcomas that also includes MSI analysis, and FoundationACT, a liquid biopsy assay for solid tumors. Genomic profiling results will help inform patient eligibility and facilitate enrollment in clinical trials. Samples will be processed at any one of Foundation Medicine's laboratories located in the United States and Europe.
See more about the Foundation Medicine on Meddevicetracker.
HeartFlow Announces More Than 185 Million Patients Have Access to Non-Invasive HeartFlow FFRct Analysis
HeartFlow announced that seven new commercial payers issued positive medical policies covering the use of the HeartFlow FFRct Analysis following a coronary computed tomography angiogram (CCTA). The HeartFlow Analysis is a non-invasive technology that creates a personalized 3D model of the heart and simulates blood flow to help clinicians diagnose and treat patients with suspected heart disease.
The positive medical policies were issued by Cigna; Florida Blue; the Blue Cross and Blue Shield plans of Michigan, North Carolina, and Vermont; Highmark, Inc.; and Independence Blue Cross. Commercial coverage for the HeartFlow Analysis is now available for approximately 130 million patients, in addition to the Centers for Medicare & Medicaid Services (CMS) recent decision to assign a New Technology APC payment for the HeartFlow FFRct Analysis for more than 55 million Medicare beneficiaries.
See more about HeartFlow FFRCT on Meddevicetracker.
January 31, 2018
Cagent Vascular Presents PRELUDE Data at LINC
The PRELUDE Study results were presented at the 2018 Leipzig Interventional Course (LINC) on January 31, 2018 in a presentation titled "The PRELUDE study: PRospective Study for the TrEatment of Atherosclerotic LEsions in the Superficial Femoral and/or Popliteal Arteries using the Serrantor DevicE".
The PRELUDE was a single arm, prospective, multi-center feasibility study enrolling up to 30 subjects with obstructive superficial femoral or popliteal artery lesions. Follow-up was taken at 30 days and 6 months.
• Study Objectives & Primary Endpoints achieved
• Serranator is safe and effective in treating critical femoropopliteal lesions
• 100% device success
• 100% serration effect demonstrated in OCT and IVUS (n=10)
• Acute results show low residual stenosis (mean 23%)
• Equally effective in lumen gain in both moderate and severely calcified lesions
• 100% Patency at 30 days
• 100% freedom from TLR at 30 days and 6 months
See more about Serranator Alto PTA Serration Balloon Catheter on Meddevicetracker.
The summary results were taken from a 25-patient cohort of the previously reported European three-stage 75 patient Clinical study, consisting of 80% Type 1 and 20% Type 2 Diabetics. The study was designed as a single center open-label, single arm, within-subject comparison of sugarBEAT®, with blood samples drawn from a venous catheter at corresponding time points, with glucose concentration measured using a Laboratory blood glucose analyzer, ARCHITECT C8000. Each patient continuously wore sugarBEAT® for 14 hours on seven consecutive days. Three of the seven days were in-clinic where venous blood samples were taken at 15 minute intervals over a continuous 12-hour period.
Results indicate an overall MARD (Mean Absolute Relative Difference) of 13.76% over a broad dynamic glucose concentration range. However, up to 70% of the data from the study paired between sugarBEAT and the venous blood glucose concentration achieved an average MARD of 10.28%, denoting even greater accuracy. A MARD of 10% is deemed to be sufficient for making therapeutic decisions. No serious or major device related adverse events were noted.
See more about sugarBEAT on Meddevicetracker.
February 1, 2018
German National Health Insurance Agency Announces Addition of ReWalk 6.0 System to National Medical Device Directory
GKV-Spitzenverband, the head office of German statutory health insurance (SHI), confirmed their decision to list the ReWalk Personal 6.0 Exoskeleton System in the German Medical Device Directory (MDD, Hilfsmittelverzeichnis), according to §139 SGB V. The MDD is a comprehensive list of all medical devices which are principally and regularly reimbursed by German SHI providers. This decision means that ReWalk will be listed among all medical devices for compensation, which SHI providers can procure for any approved beneficiary on a case-by-case basis.
The ReWalk Personal will be classified as “an innovative device for the immediate compensation of a handicap” in the MDD, and will be listed under a new subcategory for product group 23. The official publication of the MDD, which is issued annually, is expected within the next three months.
The GKV decision follows a similar policy issuance by German accident insurer BG in 2017, which provided for rental and procurement of ReWalk 6.0 Personal Systems for qualifying beneficiaries.
See more about ReWalk on Meddevicetracker.
LivaNova Announced CE Mark for New Family of Adult Arterial Cannulae
LivaNova announced it has achieved CE Mark for its new PureFlex line of adult arterial cannulae. Engineered to improve the critical link between the patient and extracorporeal circulation, PureFlex cannulae provide curved and straight tip options. The phthalate (DEHP)-free flexible tubing features exceptional transparency and a wire-reinforcement spring to deliver flexibility without kinking.
See more about PureFlex Arterial Cannulae on Meddevicetracker.
February 2, 2018
Apple Eyes FDA Approval Filing for Investigational Heart Device
Apple has told participants in its heart study that their data will be used to seek FDA approval for an investigational device. The study is using Apple Watch sensors and related algorithms to identify irregular heart rhythms. This study is part of the development of a new investigational device and certain study data will be used for FDA submission to seek approval of the investigational device. The investigational device is the study app downloaded by participants in the trial, not a dedicated piece of hardware.
In the case of Apple Heart Study, the software is likely to consist of algorithms that interpret data gathered by Watch. These algorithms will analyze heart rate data from Watch and notify the user if it detects a red flag, such as evidence the wearer suffers from atrial fibrillation or another serious heart condition. In the trial, participants with potential heart conditions are offered video consultations with the study’s medical team. The team will then send electrocardiogram patches to some patients.
See more about Apple Heart Study Mobile App on Meddevicetracker.