November 14, 2016
Hologic Launches the NovaSure ADVANCED System in Europe, Canada, and Australia
Hologic announced the launch of its next-generation NovaSure 6mm global endometrial ablation (GEA) system, NovaSure ADVANCED, a system used to treat women with abnormal uterine bleeding by applying radiofrequency energy to the endometrium and gently removing the lining of the uterus in two minutes or less. The system has been CE-marked and is being launched in Europe, Canada and Australia. As an alternative to the 8mm NovaSure device, the 6mm device requires less dilation based on a smaller sheath size, which can improve patient comfort, especially for patients who have difficulty dilating. Novasure ADVANCED features an acorn-like shaped cervical seal with 13% more working length than the previous product, rounded Smooth Access tips that simplify insertion, and a blue handle that serves as a useful reminder for how the device should be inserted.
See more information on the NovaSure ADVANCED System on Meddevicetracker.
Medtronic Receives PMA Approval for Claria MRI Quad CRT-D SureScan
Medtronic received U.S. Food and Drug Administration (FDA) approval for the Claria MRI Quad Cardiac Resynchronization Therapy Defibrillator (CRT-D) SureScan device for patients with heart failure. Claria MRI Quad CRT-D is approved for scanning in both 1.5 and 3 Tesla (T) magnetic resonance imaging (MRI) machines. The device is a cardiac resynchronization therapy defibrillator that uses Medtronic’s EffectivCRT Diagnostic and the EffectivCRT during AF algorithm, which automatically adjusts pacing rates - without adversely affecting the average heart rate - to tailor the therapy to individual patients. It also features Medtronic's AdaptivCRT algorithm, which has been shown to improve CRT response rate; VectorExpress 2.0, an automated in-office test that reduces lead programming to two minutes and reveals clinically actionable information to help physicians select optimal pacing configurations for each patient; Performa MRI SureScan Quadripolar Leads, which include short bipolar spacing to reduce phrenic nerve stimulation occurrence, steroid on all electrodes, and three shapes for varying patient anatomies; and SureScan MR-conditional labeling for full-body scans without positioning restrictions.
See more information on the Claria MRI Quad CRT-D SureScan on Meddevicetracker.
St. Jude Receives PMA Supplemental Approval for Proclaim Elite Spinal Cord Stimulation System
St. Jude Medical announced that it received U.S. Food and Drug Administration approval for full-body magnetic resonance (MR) Conditional labeling for the Proclaim Elite Spinal Cord Stimulation (SCS) System, a recharge-free system designed to offer patients future approved upgrades through software updates without the need to surgically replace their device. This approval allows patients who receive the SCS system to undergo full-body magnetic resonance imaging (MRI) diagnostic scans within approved parameters and access the benefits of BurstDR stimulation therapy, a physician-designed form of SCS that utilizes intermittent burst pulses designed to mimic the body’s natural nerve impulse patterns. Full-body MRI compatibility is the second major upgrade to the Proclaim Elite SCS system following the recent approval of BurstDR Stimulation. BurstDR is clinically proven to provide patients superior pain relief by reducing their physical pain and addressing their emotional response to pain as measured by visual analogue scale (VAS) scoring.
See more information on the Proclaim Elite SCS System on Meddevicetracker.
November 15, 2016
Boston Scientific Acquires Distal Access Gynecology and Urology Portfolio
Boston Scientific acquired the gynecology and urology portfolio of Distal Access, LLC, a Salt Lake City-based company that designs minimally invasive medical devices. The portfolio includes the Resectr Tissue Resection Device, a single-use solution designed to effectively remove uterine polyps, which can cause a variety of symptoms, including abnormal uterine bleeding and infertility. The Resectr device is compatible with a broad range of hysteroscopes and enables physicians to treat patients with polyps in an office, hospital or ambulatory surgery center and reduces the need for investment in additional capital equipment required with traditional surgical tools used in this procedure. The urology and pelvic health portfolio also includes products focused on kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction, male incontinence and pelvic floor disorders. The acquisition of the gynecology and urology portfolio from Distal Access is immaterial to earnings per share (EPS) in 2016 and 2017 on an adjusted and GAAP basis. Specific terms of the transaction were not disclosed.
See more information on Resectr on Meddevicetracker.
Impulse Dynamics Receives CE Mark Approval for Optimizer Smart
Impulse Dynamics launched the next generation of its Optimizer device, the Optimizer Smart, in Europe after it received CE mark approval. Optimizer Smart is a minimally invasive implantable device designed to treat chronic heart failure (CHF) in patients that are symptomatic despite appropriate medical therapy. The device features a new two-lead configuration that enables an easier and faster implantation procedure. Based on novel cardiac contractility modulation (CCM) technology, Optimizer Smart delivers non-excitatory electric pulses to the heart muscle, with the potential of enhancing cardiac strength. The Optimizer system serves as a treatment option for approximately 70 percent of CHF patients with advanced symptoms but who have a normal QRS duration, and are therefore not suitable for cardiac resynchronization therapy (CRT).
See more information on Optimizer Smart on Meddevicetracker.
November 16, 2016
SYNGIS Launches TruePrime Liquid Biopsy
SYNGIS announced the launch of its TruePrime Liquid Biopsy Kit, an amplifications kit for ct-DNA (circulating tumor DNA) used in the detection, analysis and monitoring of early tumor stages. The TruePrime Liquid Biopsy features technology that selectively amplifies cancerous DNA in blood samples, which provides higher quality DNA as it amplifies more accurately with less bias than any other DNA amplification technology currently available. Current techniques for cell-free DNA (cf-DNA) analysis are limited due to a lack of sensitivity. These limitations are inherently linked with the low abundance of ct-DNA present in bodily fluid samples, particularly when such samples are to be analyzed by next generation sequencing (NGS). The TruePrime ct-DNA amplification kit can be used for oncology research as well as in the field of precise medicine, and has the potential to be used as a diagnostic tool for early stage tumors and tumor monitoring. SYNGIS mentioned that it holds patents for TruePrime in several jurisdictions and has recently submitted additional patent applications to further protect the technology.
See more information on the TruePrime Liquid Biopsy Kit on Meddevicetracker.
Medtronic Receives FDA Approval for an Expanded Indication for Solitaire
Medtronic announced that the U.S. Food and Drug Administration (FDA) has cleared an expanded indication for the Solitaire Revascularization device, a mechanical self-expanding and fully retrievable thrombectomy device with a parametric, overlapping, nitinol stent-based design which allows for restoration of blood flood, administration of medical therapy, and retrieval of clots in patients experiencing acute ischemic stroke. The FDA now allows the marketing of the Solitaire device as an initial therapy for acute ischemic strokes (AIS) for patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts to reduce paralysis, speech difficulties and other stroke-related disabilities. The device should be used after patients have received intravenous tissue plasminogen activator (IV t-PA) and within six hours of symptom onset. The FDA granted the expanded indication based upon a subset of data from the SWIFT PRIME trial (Solitaire FR With the Intention For Thrombectomy as PRIMary Endovascular Treatment for Acute Ischemic Stroke), published in the New England Journal of Medicine in June 2015. The data demonstrates that the addition of the Solitaire device to IV-tPA significantly decreased post-stroke disability and increased the number of patients who were functionally independent with mRS scores of 0-2 within 90 days after a stroke (62.7% vs. 36.8%).
See more information on the Solitaire on Meddevicetracker.
November 17, 2016
Genedrive Receives CE-IVD Certification for Genedrive IL28B SNP Human Genotyping Test
Genedrive announced that it received CE-IVD certification for its Genedrive IL28B SNP human genotyping test. The test is performed from a buccal cheek swab using the Genedrive hand-held real-time PCR genotyping and sequence analysis device. The Genedrive platform features polymorphism genotyping capabilities, which provides on-the-spot stratification, negating the need for costly and time consuming patient recall whilst central laboratory tests are processed. It is a low cost instrument that features simplicity of operation and connectivity options, allowing its deployment to large numbers of coordinated trial sites. Data from a clinical trial supporting the CE-IVD application showed that the Genedrive human genotyping IL28B SNP test was 100% accurate in detecting inherited genetic polymorphisms in HCV patients when compared to the Roche TaqMan PCR. Genedrive produces results in 50 minutes compared to the standard approach which uses a blood sample and which can have a service lab return time of 2 -3 weeks for results.
See more on the Genedrive IL28B SNP and the TaqMan PCR on Meddevicetracker.
Merck Launches the Geri+ Incubator in Europe and Canada
Merck announced the launch of Geri+, a fertility technology that combines the Geri embryo incubator and the Eeva algorithm, extending its product portfolio to support all steps performed by fertility laboratories during assisted reproductive treatment (ART). Geri+ functions as a multifunctional incubator, which gives embryologists a multitude of possibilities around embryo analytics. It brings together the benefits of undisturbed incubation, while complying with the high control and safety standards of the Geri incubator and the analytics of the Eeva software, the first automated algorithm clinically shown to improve embryo assessment. Geri+ stems from the ARTinnovations development hub, an incubator for ideas and innovations for fertility treatment and technologies that was formed by Merck as a collaboration with Genea Biomedx Propriety Ltd. The product will be available immediately in Europe and Canada.
See more on the Geri+