September 25, 2017
Boston Scientific Receives U.S. Approval of Resonate MRI ICDs and CRT-Ds
Boston Scientific announced the launch of the Resonate family of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems featuring the HeartLogic Heart Failure Diagnostic to help physicians improve heart failure (HF) management. The new devices, which are approved by the U.S. Food and Drug Administration for conditional use in a magnetic resonance imaging (MRI) environment, also combine the company's SmartCRT Technology with EnduraLife Battery Technology to improve patient management through personalized care.
The MR-conditional labeling allows patients implanted with specific models of the company's Resonate family of devices to receive full-body MR scans in 1.5 Tesla environments when conditions of use are met. This capability extends beyond the Resonate family and includes those patients who were previously implanted with AUTOGEN, DYNAGEN, INOGEN ICD and CRT-D devices. MRI approval was based on clinical trial results from the global ENABLE MRI study, which was completed earlier this year.
See more information Resonate CRT-D and Resonate ICD on Meddevicetracker.
Gelesis Announces Top-Line Results from Gelesis100 Weight-Loss Study
Gelesis announced topline results from a pivotal weight loss study of one of its product candidates, Gelesis100. The study exceeded one of the two co-primary endpoints with 58% of adults in the Gelesis100 treatment arm achieving clinically meaningful weight loss of 5% or more during the study. The percent of patients who achieved 5% or more weight loss was statistically significant compared to placebo (58% vs. 42%, p=0.0028). Additionally, almost twice as many adults on Gelesis100 lost 10% or more of their body weight compared to the placebo group (20% vs. 12%, p=0.027). Although the study did not meet the other co-primary endpoint of 3% mean difference from placebo, the Gelesis100-treated adults showed statistically significant weight loss vs. placebo (p=0.0032). Gelesis100 showed no increased safety risk, no serious adverse events, and a lower dropout rate compared to placebo.
Full results will be presented at a scientific conference and will be submitted for publication in a peer-reviewed medical journal. Given the demonstrated weight loss and safety profile, Gelesis plans to discuss filing with regulatory authorities and if they are supportive, plans to file for approval.
See more information Gelesis100 on Meddevicetracker.
September 26, 2017
SeaSpine Announces Launch of Shoreline ACS System
SeaSpine announced the full commercial launch of the Shoreline Anterior Cervical Standalone (ACS) System, featuring TruProfile technology.
The Shoreline ACS System is designed to deliver maximum flexibility and modularity, offering zero- and low-profile plating options, including two, three and four hole variations, as well as 10 and 15 degree lordotic implants. This selection provides surgeons the ability to intraoperatively address a wide range of anatomy, surgical situations or bone. In addition, TruProfile technology offers a low profile plate design at 1.6mm thickness, minimizing the profile on the anterior aspect of the spine and minimizing cephalad caudal encroachment of adjacent segments.
See more information the Shoreline ACS System on Meddevicetracker.
Guardant Health Receives IDE Approval for Guardant360 Companion Diagnostic
Guardant Health announced that it received an investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to provide genomic testing for a clinical trial investigating the small molecule, c-Met kinase inhibitor tepotinib. Under a collaboration agreement between Guardant Health and Merck KGaA, which operates its biopharmaceutical business as EMD Serono in the U.S. and Canada, the Guardant360 test will be the liquid biopsy option to identify advanced lung cancer patients with MET exon 14 skipping alterations who may qualify for the ongoing Phase II tepotinib trial.
See more information the Guardant360 Companion Diagnostic on Meddevicetracker.
September 27, 2017
Medtronic’ HeartWare System Approved as a Destination Therapy
Medtronic announced it has received U.S. Food and Drug Administration (FDA) approval for its HeartWare HVAD System as a destination therapy for patients with advanced heart failure who are not candidates for heart transplants. The HVAD System, a left ventricular assist device or LVAD, helps the heart pump and increases the amount of blood that flows through the body.
FDA approval is based on results from the ENDURANCE and ENDURANCE Supplemental trials, which enrolled nearly 1,000 destination therapy patients. The data support the safety and effectiveness of the HeartWare HVAD System for patients with advanced, refractory left ventricular heart failure as a bridge to cardiac transplantation (BTT), or myocardial recovery, or as destination therapy (DT) in patients for whom subsequent transplantation is not planned.
See more information on the HeartWare Ventricular Assist System on Meddevicetracker.
Abbott Receives Approval for FreeStyle Libre Flash Glucose Monitoring System
Abbott announced that the U.S. Food and Drug Administration (FDA) has approved the FreeStyle Libre Flash Glucose Monitoring System as a replacement for blood glucose monitoring (BGM) for adults with diabetes in the U.S. This new glucose sensing technology eliminates the need for routine finger sticks and is the only personal continuous glucose monitor (CGM) that does not require finger stick calibration. This is the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions without calibration using a blood sample from the fingertip (often referred to as a “fingerstick”). Even with current CGM devices, people still have to finger stick at least twice per day, based on their system, to calibrate their devices to ensure accuracy. However, the FreeStyle Libre system is factory calibrated so daily calibration is not required.
The system reduces the need for fingerstick testing by using a small sensor wire inserted below the skin’s surface that continuously measures and monitors glucose levels. Users can determine glucose levels by waving a dedicated, mobile reader above the sensor wire to determine if glucose levels are too high (hyperglycemia) or too low (hypoglycemia), and how glucose levels are changing.
See more information on FreeStyle Libre Flash on Meddevicetracker.
September 28, 2017
Avita Medical Submits PMA for ReCell Device
Avita Medical announced that it has submitted to the U.S. Food & Drug Administration (FDA) a Premarket Approval (PMA) application for its ReCell Autologous Cell Harvesting Device for treatment of burn injuries. Use of the ReCell Autologous Cell Harvesting Device is intended to reduce the amount of skin harvesting required relative to conventional treatment of burn injuries.
Development of the PMA for the ReCell device has been supported through Avita’s Contract with the Office of Biomedical Advanced Research and Development Authority (BARDA), within the Assistant Secretary for Preparedness and Response (ASPR), a division of the U.S. Department of Health and Human Services. Pending PMA approval, Avita is anticipating launching the Recell in the U.S. in 2018.
See more information on the ReCell Device on Meddevicetracker.
Heart Failure Start Up Magenta Medical Announces $15 Million Series B Financing
Magenta Medical announced the closing of its $15M series B financing round. The syndicate of investors is comprised of Abiomed Inc., Pitango Venture Capital, JAFCO Co., Ltd., and a group of industry luminaries and cardiovascular experts. Founded in October, 2012, Magenta Medical is developing novel therapeutic approaches to the management and treatment of Acute Heart Failure.
Magenta will use the funds to support an ongoing European clinical trial of the acute HF therapy it has developed, a catheter-based system designed as "non-pharmacological, hemodynamically-based, more physiological" alternative to diuretics. The firm is hoping to complete its European clinical trial and gain a CE mark 18 to 24 months from now.
See more information on the Magenta Medical on Meddevicetracker.
Roche Gains CE Label Expansion for TECENTRIQ PD-L1 Testing in Lung and Bladder Cancers
Roche announced the expanded use of the VENTANA PD-L1 (SP142) Assay in non-small cell lung cancer (NSCLC) and metastatic urothelial carcinoma (mUC) in CE (Conformité Européene) markets where the Roche cancer immunotherapy medicine TECENTRIQ is approved.
This assay evaluates patient PD-L1 status using immune cell and tumour cell staining within the tumour microenvironment, providing clinicians with information that may guide treatment decisions. It was previously approved by the US Food and Drug Administration (FDA) in May 2016 as a complementary diagnostic to provide PD-L1 status on patients with NSCLC and mUC who are considering treatment with TECENTRIQ.
See more information on the VENTANA PD-L1 (SP142) Assay on Meddevicetracker.
September 29, 2017
K2M Receives FDA Clearance for Next-Generation YUKON OCT Spinal System
K2M announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its YUKON OCT Spinal System. YUKON OCT offers surgeons an advanced system aimed at facilitating fusion with posterior fixation in the occipito-cervico-thoracic regions of the spine with the goal of helping to achieve three-dimensional spinal balance.
The YUKON OCT Spinal System features newly designed top-loading, high angulation, polyaxial screws that provide up to 105 degrees of polyaxial angulation. YUKON OCT screw heads accept both Ø3.5 & Ø4.0 mm rods in both cobalt chrome and titanium, and accommodate construct rigidity based on degenerative or deformity corrections. Square thread set screws facilitate screw introduction and minimize the potential for cross-threading, while an updated occipital plate features integrated lateral holes with the goal of enhancing occiput fixation. YUKON OCT is a comprehensive system that offers surgeons the ability to treat a variety of spinal conditions—including routine degenerative cases, revisions, and complex cervical deformities.
See more information on the YUKON OCT Spinal System on Meddevicetracker.