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 August 14, 2017


Medtronic Announces Resolute Onyx DES Antiplatelet Therapy Study



Medtronic announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT) - the combination of aspirin and an anti-clotting medication - in patients implanted with the Resolute Onyx Drug-Eluting Stent (DES) during percutaneous coronary intervention (PCI). Designed to evaluate clinical DAPT outcomes between two DES for the first time ever, the RESOLUTE ONYX ONE-MONTH DAPT Study intends to help inform DAPT guidelines for newer-generation DES that currently favor bare-metal stents (BMS) for patients with stable ischemic heart disease who might require a shorter dual antiplatelet regimen.  The study will enroll up to approximately 2,000 patients at approximately 70 sites worldwide.



See more information the Resolute Onyx Drug Eluting Stent on Meddevicetracker.



Dexcom G5 CGM Coming to Apple Watch Soon


Apple announced, that after the next Apple Watch software update (“OS4”), the Dexcom G5 transmitter will be capable of talking to the watch directly via Bluetooth – even when the iPhone is out of range. This will free Apple Watch and Dexcom G5 users from always being tethered to their iPhone to get glucose data. For instance, if a G5 user is on a run or their phone dies, they will still get G5 data on the Watch. It’s not clear when Dexcom will launch this app update.



See more information the Dexcom G5 Mobile CGM System on Meddevicetracker.



Dexcom Begins Shipping First Medicare G5 CGM Bundles


Dexcom announced that it began shipping out “test case” Medicare G5 CGM bundles to a handful of users, which now include the Contour Next One blood glucose monitor (BGM) and strips for calibration along with Dexcom G5 CGM sensors, transmitters, and a receiver. The purpose of these “test cases” is to ensure successful documentation and reimbursement by Medicare before shipping larger quantities as the year progresses.



These first shipments follow Medicare’s March 2017 announcement that it would reimburse “therapeutic CGMs” – CGMs approved to make insulin dosing decisions without a confirmatory fingerstick – for people with type I or type II diabetes on intensive insulin therapy. At present, people with Medicare are eligible to have their G5 reimbursed if they have a diagnosis of type I or type II diabetes, check blood glucose using a meter at least four times per day, inject insulin multiple times daily or use an insulin pump, and follow an insulin regimen that requires frequent adjustment made possible by CGM readings. 



See more information the Dexcom G5 Mobile CGM System on Meddevicetracker.




August 15, 2017


Tandem Diabetes Begins Enrollment in Predictive Low Glucose Suspend (PLGS) Trial


Tandem Diabetes announced enrollment of the first patients in an at-home pivotal trial for its t:slim X2 Insulin Pump using Tandem's predictive low glucose suspend (PLGS) technology. The insulin pump system, which uses an integrated Dexcom G5 Mobile Continuous Glucose Monitor (CGM), is designed to suspend insulin delivery when low blood glucose is predicted and subsequently resume insulin delivery when glucose levels begin to rise.



The PROLOG (PLGS for Reduction Of LOw Glucose) study is a multi-center, randomized crossover study comparing two 3-week periods of at-home insulin pump use, one period using the t:slim X2 Pump with PLGS, and another period using a standard CGM-integrated t:slim X2 Pump without automated insulin suspension. The clinical trial will include 90 participants with type 1 diabetes ages 6 and above at five research centers across the United States.



See more information the Automated Insulin Delivery System on Meddevicetracker.



BioStable Announces FDA Clearance of the HAART 200 Device 


BioStable Science & Engineering announced it has received FDA market clearance for the HAART 200 Aortic Annuloplasty Device, the first and only annuloplasty device designed specifically for bicuspid aortic valve repair. 



The HAART 200 Aortic Annuloplasty Device is designed to facilitate valve repair in patients with aortic valve insufficiency due to BAV. The device is designed to reduce annular diameter based upon leaflet size, to conform the annulus to a circular, symmetric shape for improved valve function, and to stabilize the annular geometry long-term. BioStable is expecting to perform the first cases in the U.S. in a targeted launch of the HAART 200 in fall 2017.



See more information the HAART 200 on Meddevicetracker.



Vascular Dynamics to Initiate U.S. Trial for MobiusHD System for Resistant Hypertension


Vascular Dynamics announced that the United States Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) application to initiate its pivotal trial for its MobiusHD System for the treatment of resistant hypertension. The study is expected to initiate in September 2017.



The CALM (Controlling and Lowering Blood Pressure with MobiusHD) 2 trial is a multi-center pivotal study designed to evaluate the safety and effectiveness of the MobiusHD System. The MobiusHD System, a minimally-invasive system, capitalizes on the ability of the body’s baroreceptor mechanism to regulate blood pressure. The company will evaluate patients from select locations throughout the United States whose hypertension remains uncontrolled despite using three or more anti-hypertensive pharmacologic therapies. VDI also intends to conduct the CALM 2 trial in certain European countries following appropriate regulatory authorization.



See more information the MobiusHD on Meddevicetracker.





August 16, 2017


Stryker Spine Division Receives FDA Clearance for Serrato Pedicle Screw


Stryker’s Spine division announced that its Serrato Pedicle Screw, intended for use in the non-cervical spine as part of the company’s Xia 3 Spinal System, has received 510(k) clearance from the U.S. Food and Drug Administration. The Xia 3 Spinal System is an orthopaedic spinal system comprised of a variety of shapes and sizes of screws, blockers, and hooks that affix several different types of rods and connectors to vertebrae or the spinal column for purposes of stabilization, or corrective action through the application of force.



Serrato Pedicle Screws feature enhanced serrated cutting flutes, a unique dual-thread pattern with an increased number of leads for rapid insertion, and a patented buttress thread locking mechanism designed to minimize cross threading and splaying of the screw head.



See more information on the Xia 3 Spinal System on Meddevicetracker.




August 17, 2017

 Endologix Announces Positive Results from AFX LEOPARD Study


Endologix announced positive interim results from the LEOPARD (Looking at Evar Outcomes by Primary Analysis of Randomized Data) clinical study, which directly compares the Endologix AFX and AFX2 endografts to other commercially available bifurcated aortic endografts. Based upon the patients that have completed their one-year follow-up, freedom from ARC with AFX/AFX2 is 84.7%, compared to 82.0% with the other devices.



These preliminary results demonstrate similar outcomes between the endografts under investigation, but there is a trend towards better performance for AFX/AFX2, which is the only device that preserves the patient's aortic bifurcation.



See more information on the AFX Endovascular AAA System on Meddevicetracker.



Globus Medical Receives FDA Approval for Excelsius GPS


Globus Medical announced that the U.S. Food and Drug Administration (FDA) has issued 510(k) clearance for the Excelsius GPS. This platform technology supports minimally invasive and open orthopedic and neurosurgical procedures, with screw placement applications in spine and orthopedic surgery. Excelsius GPS integrates Globus Medical implants and instruments and is compatible with pre-operative CT, intra-operative CT and fluoroscopic imaging modalities. The system is designed to minimize radiation exposure, streamline workflow, and reproducibly assist in implant placement.



See more information on the Excelsius GPS on Meddevicetracker.



HeartSciences Launches MyoVista in Europe


HeartSciences announced the European launch of MyoVista high sensitivity electrocardiograph (hsECG) Testing Device. MyoVista measures the heart's energy during each heartbeat using a type of advanced signal processing known as Continuous Wavelet Transform (CWT). MyoVista hsECG uses the same 12-lead, at-rest testing protocol as traditional ECG devices , however MyoVista is a single test that provides healthcare practitioners with unique informatics, as well as conventional 12-lead resting ECG tracings and conventional ECG interpretive analysis. Combined, these assist identification of cardiac dysfunction related to Coronary Artery Disease (CAD) and structural disease, as well as identifying arrhythmias.



MyoVista hsECG is available across the European Union, where it received the CE (Conformité Européenne) Mark approval for commercial sale. The company is also in the process of expanding distribution to Australia, the Middle East, Latin America, Asia-Pacific and Canada. The device is not currently available for sale or use in the United States. HeartSciences expects to seek U.S. Food and Drug Administration clearance for MyoVista in 2018.



See more information on the MyoVista on Meddevicetracker.





August 18, 2017


Pharmaxis Announces Positive Recommendation for Bronchitol Inhaler


Pharmaxis announced it has received a positive recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia for expanded reimbursement of its drug Bronchitol and Single-Dose Inhaler for the treatment of cystic fibrosis (CF). Bronchitol is a portable mucus clearance drug agent delivered via a small handheld inhaler device.  



See more information on the Bronchitol Inhaler on Meddevicetracker.




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