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November 6, 2017

Abbott Receives Japanese Approval for MitraClip

Abbott announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved the company's MitraClip device for treatment of people with mitral regurgitation (MR). The MitraClip system is a catheter-based, minimally-invasive therapy that is delivered to the heart through a blood vessel in the leg. By securing a portion of the leaflets of the mitral valve with a clip, the heart can pump blood more efficiently throughout the body, thereby relieving the symptoms of severe MR and improving patient quality of life.



The approval in Japan is based on the results of the AVJ-514 clinical trial and extensive global experience and clinical data available for the MitraClip System. In the AVJ-514 study, patients with severe degenerative mitral regurgitation or functional mitral regurgitation were treated at six facilities in Japan.



See more information MitraClip on Meddevicetracker.



Medtronic Announces CE Mark Approval for Intellis Platform



Medtronic announced that it received CE (Conformité Européenne) Mark for the Intellis platform for both Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) as an aid in the management of certain types of chronic pain.  Intellis is now available in Europe and the United States.



The Intellis platform is managed on the Samsung Galaxy Tab S2 tablet interface and can record and track patient activity 24/7. Intellis can help optimize treatment and improve patient-physician communication by tracking and sharing daily activities, body positions and therapy usage and giving physicians an objective look at mobility and progress. 



See more information Intellis on Meddevicetracker.



HeartFlow Announces Positive CMS Decision for FFRct Analysis



HeartFlow announced that the Centers for Medicare & Medicaid Services (CMS) has finalized a New Technology Ambulatory Payment Classification (APC) for the HeartFlow FFRct analysis. Under the APC payment system, hospitals enrolled in Medicare that bill CMS for the HeartFlow FFRct Analysis for Medicare patients will be eligible for reimbursement at a rate of $1,450.50 for the technical component of the test. This payment rate will take effect on January 1, 2018.


See more information HeartFlow FFRCT on Meddevicetracker.




November 7, 2017

Axonics Receives IDE Approval to Start Pivotal U.S. Study

Axonics Modulation Technologies announced it has received an Investigational Device Exemption (IDE) from the U.S. Food & Drug Administration (FDA) to conduct a pivotal study designed to gain FDA approval in the United States. 


Axonics expects to begin enrolling patients in the clinical study (ARTISAN-SNM) in November 2017, with a target of approximately 120 patients to be implanted at 15 centers of excellence located in the U.S. and Western Europe. The ARTISAN-SNM study is a single-arm, prospective pivotal study designed to demonstrate the safety and effectiveness of the Axonics r-SNM system as an aid in the treatment of urinary urgency incontinence in patients who have failed or could not tolerate more conservative treatments.



See more information the Axonics SNM System on Meddevicetracker.



Takeda Partners with Portal Instruments to Develop Needle-Free Device


Takeda Pharmaceutical and Portal Instruments announced a collaboration to develop and commercialize Portal PRIME Injection needle-free drug delivery device for potential use with Takeda’s investigational or approved biologic medicines. Portal’s needle-free drug delivery device delivers the biologic through a pressurized liquid instead of a needle, and has been clinically shown to be less painful and preferred by patients compared to a standard needle-based injection.



The first Takeda development program to potentially utilize this device will be for investigational use with Entyvio (vedolizumab), a monoclonal antibody for adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD), which is currently administered through intravenous infusion. Under terms of the agreement, Portal will receive an initial payment with the potential to earn additional payments of up to $100 million subject to achievement of specified development, regulatory and sales-based milestones and royalties. 



See more information the Portal PRIME Injection System on Meddevicetracker.



Roche Receives FDA Approval for VENTANA ALK (D5F3) CDx Assay


Roche announced that the company has obtained U.S. Food and Drug Administration (FDA) approval for the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with the company's medicine, ALECENSA (alectinib). The VENTANA ALK (D5F3) CDx Assay has been shown in studies to identify more patients that will benefit from an anti-ALK target therapy than fluorescent in situ hybridization (FISH) testing.


See more information the VENTANA ALK CDx Assay on Meddevicetracker.




November 8, 2017

GlucoTec Announces Results from Study Using Hospital-to-Home Diabetes Therapy Management Software


GlucoTec announced that a quality improvement study led by Eastern Virginia Medical School was presented at the 17th Annual Diabetes Technology Meeting in an abstract titled "Utilization of Electronic Glycemic Management Systems For Hospital Discharge Insulin Dosing." The study observed that when providers used the Hospital-to-Home (H2H) module of Glytec’s eGlycemic Management System to guide insulin regimens prescribed at discharge, patients had no diabetes-related readmissions, urgent care visits or emergency department visits within the first 30 days.



The researchers concluded that eGMS is a useful tool for providers to use at the time of discharge to determine home insulin dosing and titration. There was reasonable BG control post-discharge, and incidence of severe hypoglycemia was minimal and there were no urgent care visits, emergency department visits or hospital readmissions within 30 days of discharge due to diabetes or glucose-related causes.         



See more information on the eGlycemic Management System on Meddevicetracker.


Cambridge Cognition Announces New Distributor for CANTAB in Finland

Cambridge Cognition announced that Hogrefe Psykologien Kustannus Oy is now an exclusive distributor of CANTAB software products for use in Finland by academic researchers and healthcare professionals.


This partnership means that Hogrefe will now be the sole Finnish distributors of Cambridge Cognition’s CANTAB tests, which are cognitive assessments used for both research and healthcare purposes.



The Hogrefe team will be distributing the following CANTAB tools for customers in Finland: CANTAB Connect Research, a cloud-based cognitive assessment platform; CANTAB Mobile, a sensitive memory assessment which can help identify those with a clinically relevant memory impairment that could be indicative of Alzheimer’s disease; and CANTAB Insight, a CE-marked medical device that helps to determine an individual’s cognitive performance across five core cognitive domains



See more information on CANTAB Software Products on Meddevicetracker.



First Patient Has Novel Reninshaw Drug Delivery System Implanted for Parkinson’s Trial


Renishaw announced that the first patient in a clinical study was implanted with a novel drug delivery system, developed by Renishaw. The procedure took place at Karolinska University Hospital in Stockholm, Sweden. The implantation marks the beginning of a joint clinical study between Renishaw and Herantis Pharma. This Phase I/II clinical study will investigate the treatment of Parkinson's disease using Cerebral Dopamine Neurotrophic Factor (CDNF) delivered with Renishaw's system.



The study will involve 18 volunteers across three sites — two in Sweden and one in Finland. It will evaluate the safety and tolerability of the drug delivery system and CDNF, a large molecule that could slow the progression of Parkinson's disease, improving the quality of life for patients and prolong their lives. For six months, each volunteer will receive monthly infusions of CDNF, or artificial CerebroSpinal Fluid (aCSF) for those receiving the placebo, via the drug delivery system.


See more information on the Renishaw Drug Delivery System on Meddevicetracker.





November 9, 2017

Stryker Receives HDE Approval for the Neuroform Atlas Stent System to Treat Wide Neck Aneurysms

Stryker announced that the U.S. Food and Drug Administration has approved the Neuroform Atlas Stent System for marketing under a humanitarian device exemption (HDE). The device is to be utilized in conjunction with neurovascular embolic coils for the treatment of wide neck, intracranial, saccular aneurysms and allows the company to begin U.S. commercialization efforts immediately. 


See more information on the Neuroform EZ Stent System on Meddevicetracker.




November 10, 2017

Roche Diagnostics and Start-Up Inotrem Collaborate on Septic Shock Diagnostic


Inotrem announced a research and development collaboration with Roche Diagnostics to develop a companion diagnostic test using a solube plasma circulating protein (sTREM-1) developed by Inotrem and the Roche proprietary Elecsys platform. It is Roche Diagnostics’ first collaboration agreement with a start-up biotech company.



Under the terms of the agreement, Roche and Inotrem will work together to develop an in vitro robust prototype assay for quantitative measurement of soluble TREM-1 (sTREM-1) in plasma samples of septic shock patients. Inotrem is currently conducting a clinical Phase II trial in patients with septic shock to demonstrate the benefit of its lead compound, Motrem (LR12) in the treatment of septic shock. The collaboration with Roche Diagnostics may lead to a companion diagnostic supporting the development of Motrem.



See more information on the Elecsys Motrem Compaion Diagnostic on Meddevicetracker.

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