June 5, 2017
Arsenal Medical Receives Unconditional IDE Approval to Initiate ResQFoam Clinical Study
Arsenal Medical announced that they have received unconditional IDE approval from the U.S. Food & Drug Administration (FDA) to conduct a clinical study in U.S. trauma centers to examine the safety and effectiveness of ResQFoam, a decision supported by pre-clinical data that has been published in more than ten peer-reviewed manuscripts and several national trauma conferences. The Company has received funding to complete clinical and manufacturing development from the Defense Advanced Research Projects Agency (DARPA) in the form of a $15.5 million Phase II contract in December 2012 and a $14 million contract in December 2015, which was partially funded by the U.S. Army Medical Research and Material Command (USAMRMC). ResQFoam is a biocompatible, self-expanding biomaterial, designed to be administered at the point of injury to stop massive blood loss in patients suffering from life-threatening abdominal trauma. The material fills and conforms to the abdominal cavity to control bleeding before being removed at the time of surgery. ResQFoam may provide a life-saving bridge to surgical care for those who may otherwise die before reaching surgical care, both in civilian and military settings. Abdominal bleeding accounts for the majority of preventable fatalities in injured warfighters. ResQFoam will also be evaluated in the REVIVE clinical trial, a Phase I study in the United Kingdom evaluating the safety and efficacy of ResQFoam in reducing exsanguination.
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Expanding Orthopedics Receives CE Mark Approval for FLXfit 15
Expanding Orthopedics announced that the FLXfit 15 was granted CE Mark approval, enhancing the FLXfit 3D expandable cage, a device intended to treat patients with degenerative disc disease at one or two contiguous levels from L2 to S2. The product is an expandable, articulated interbody fusion device used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy. The cage is composed of titanium and articulates laterally as well as expands in height, which enables larger footprint support as well as restoration of disc height and lordotic angle correction. The FLXfit 15 expands up to 4mm, enables controlled lordosis correction of up to 15 degrees, and is available in two linear length options: a 50mm and a 32mm version. The open architecture of the device allows it to be packed with autogenous bone graft. Expanding Orthopedics also announced that the FLXfit 15 is the subject of a pending 510k clearance from the U.S. Food and Drug Administration (FDA) and is not yet available for sale in the U.S.
See more information on the FLXfit 3D Expandable Cage on Meddevicetracker.
Medovex Receives CE Mark Approval for DenerveX
Medovex announced that it received CE Mark approval for the DenerveX System, allowing the Company to commercialize the system in Europe. The system, consisting of a single use medical device and DenerveX Pro-40 Power Generator, denervates and removes capsular tissue from the Facet Joint in a single procedure, offering a long lasting solution to Facet Joint Syndrome (FJS). Current treatment options for FJS, also known as spinal osteoarthritis, spinal arthritis, or facet joint osteoarthritis, are generally temporary, with no long-lasting options. FJS treatment with the DenerveX System results from the combined effect of a deburring or polishing action and radiofrequency (RF) ablation treatment on the Facet Joint. Using this technique, the slowly rotating burr removes the targeted facet joint synovial membrane and joint surface while the heat ablation destroys tissue and denudes any residual nervous and synovial membrane overlying the joint, effectively removing the end point sensory tissue of the joint. The DenerveX System has not yet been cleared by the U.S. Food and Drug Administration (FDA).
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June 6, 2017
Boston Scientific Receives CE Mark Approval for Vercise Gevia Deep Brain Stimulation System
Boston Scientific announced that it received CE mark for the Vercise Gevia Deep Brain Stimulation (DBS) System, a rechargeable, magnetic resonance (MR) conditional device indicated for the treatment of movement disorder symptoms in patients with Parkinson’s disease, dystonia and essential tremor. The system features the Vercise Neural Navigator 2 with STIMVIEW Technology programming software, which allows clinicians to visualize the stimulation field while configuring DBS stimulation programs for patients. Deep Brain Stimulation involves the placement of a device that stimulates specific areas in the brain using electrical signals. This approval expands the Vercise portfolio, which consists of the Vercise Primary Cell (OC) and Vercise Gevia platforms with Vercise Cartesia Directional Lead. These offerings finely control the size, shape and direction of stimulation with multiple independent current control technology (MICC) – a critical feature for avoiding unwanted side effects and obtaining optimal DBS outcomes. The Vercise DBS system originally received CE Mark approvals for the treatment of Parkinson’s disease in September 2012, dystonia in November 2013, and essential tremor in September 2014. In October 2015, Boston Scientific announced that it had launched the Vercise DBS system in Europe. Pending regulatory approval of the system for Parkinson’s disease from the U.S. Food and Drug Administration (FDA), Boston Scientific expects to launch the system in the United States by year-end 2017.
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June 7, 2017
DexCom Receives PMA Supplemental Approval for DexCom G5
DexCom announced that the Dexcom G5 mobile app for Android devices has been granted a supplemental Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA). Beginning in June 2017, Android users will have access to the free app for the Dexcom G5 Continuous Glucose Monitor (CGM) system, providing diabetic patients with a real-time view of their glucose levels on their mobile device. Once commercially available, the app will make the Dexcom G5 Mobile device available to millions of Android device users in the U.S., complementing the launch of the iOS app version in 2015. The Dexcom G5 Mobile CGM system provides mobility and flexibility to view and share personal glucose data and trends. It uses a single digit MARD (mean Absolute Relative Difference) and features customizable alerts including a built-in low glucose (55 mg/dL) alarm to warn patients of highs and lows and how quickly they may be occurring. The G5 system was originally approved in August 2015 via a supplemental PMA to the Dexcom G4 Platinum CGM System, which was approved in October 2012. It received CE Mark approval and was launched in Europe in 2015. It also received approval from Health Canada in November 2016 and subsequently launched in Canada during the first quarter of 2017. The Dexcom G5 Mobile app for Android will initially be available on several Android devices from Samsung, Motorola, LG, and Android Wear watches. DexCom has provided a list of compatible devices in the Company website.
See more information on the Dexcom G5 CGM on Meddevicetracker.
Shanghai Microport Medical Receives CE Mark Approval for ARBORES Kyphoplastic Balloon Catheter
Shanghai Microport Medical announced that it received CE mark approval for its ARBORES Kyphoplastic Balloon Catheter, marking the official entry of Microport’s first orthopedic balloon catheter into the European market. ARBORES is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine, including use during balloon kyphoplasty with accessories like balloon pumps, puncture needles, and expanders. ARBORES comes in two configurations: one peanut-shaped and another cylindrical. The Balloon length ranges from 10mm to 20mm.
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June 8, 2017
IntelGenx Receives US Patent for VersaFilm
IntelGenx announced that the United States Patent and Trademark Office has issued U.S. Patent 9,668,970, entitled “Film Dosage Form with Extended Release Mucoadhesive Particles” for its VersaFilm technology platform. The patent covers the design and manufacturing of topical oral films (TOF) for the local (topical) treatment of diseases of the oral mucosa using mucoadhesive particles. VersaFilm is a drug delivery platform that consists of a small, thin, film intended to provide sustained release of an active agent to a target area: under or on the tongue, or inside the cheek. Once placed in the target area, the film rapidly disintegrates, providing topical or systemic drug delivery for the treatment of oral diseases and conditions such as gingivitis, buccal ulcers, canker sores, Sjörgen’s syndrome, oral mucositis and Behcet’s disease. Pending approval from the U.S. Food and Drug Administration (FDA), IntelGenx signed a binding term sheet for a license to Eli Lilly’s Tadalafil dosing U.S Patent No. 6,943,166 (the ‘166 dosing patent), allowing IntelGenx to commercialize its Tadalafil erectile dysfunction (ED) VersaFilm product. Eli Lilly later granted IntelGenx an exclusive license for commercialization of the Tadalafil ED VersaFilm in March 2017. In December 2016, IntelGenx entered into a co-development and commercialization agreement with Endo Ventures, granting Endo exclusive rights to market and sell a new product using VersaFilm in the United States for an undisclosed upfront payment and future milestone payments. With the issuance of the latest patent, IntelGenx announced that it intends to seek potential commercialization partners for TOF products in the United States.
See more information on the VersaFilm on Meddevicetracker.