20 March, 2017
NovoCure Receives Japanese Approval for the Second Generation Optune
NovoCure announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the second generation of Optune device for the treatment of adult patients with supra-tentorial glioblastoma (GBM). Used following maximal safe surgical resection and radiation therapy, Optune applies alternating electrical fields called tumor treatment fields (TTFields) to the patient’s shaved head by means of electrically insulated surface transducer arrays, such that resistively coupled electric currents are not delivered to the patient. The TTFields disrupt the rapid cell division exhibited by cancer cells. The second generation features a TTFields generator that is less than half the weight and half the size of the first generation generator, weighing less than 1.3 kilograms (2.7 pounds). After MLHW approved the first generation Optune for the treatment of recurrent GBM, Novocure established commercial operations in Japan in March 2015. In December 2016, the MLHW approved Optune for the treatment of newly diagnosed GBM. In the United States, Optune was originally approved by the U.S. Food and Drug Administration (FDA) via Premarket Approval (PMA) in April 2011, received PMA Supplemental approval in October 2015 expanding the indication to treat patients with newly-diagnosed GBM, and received PMA supplement approval for the second generation system in July 2016. Optune also received investigational device exemption (IDE) supplement approvals in December 2014 allowing all control patients in the EF-14 Phase III trial in newly diagnosed GBM to receive TTFields and another IDE supplement approval in April 2016 for a study evaluating the safety and efficacy of TTFields in combination with bevacizumab.
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Masimo Receives CE Mark Approval for Rad-97 Pulse CO-Oximeter
Masimo announced that the Rad-97 Pulse CO-Oximeter and connectivity hub received CE Mark approval for noninvasive blood pressure (NIBP) measurements. The Rad-97 Pulse CO-Oximeter includes a 1080p HD display, a rechargeable battery that lasts seven hours, multi-touch navigation for device customization, and built-in WiFi, Bluetooth, USB and Ethernet connectivity options. The monitoring platform features Measure-through Motion and Low Perfusion pulse oximetry (SpO₂), pulse rate (PR), and perfusion index (PI). Clinicians can add other monitoring solutions such as the rainbow SET measurements total hemoglobin (SpHb), methemoglobin (SpMet), acoustic respiration rate (RRa), carboxyhemoglobin (SpCO), and oxygen content (SpOC). In select markets outside the United States, Rad-97 includes an optional camera that is used in conjunction with Masimo Patient SafetyNet to provide additional viewing images and to connect other devices a patient may be using, such as glucometers and scales. Additional parameters such as Oxygen Reserve Index (ORi) and respiration rate from the pleth (RRp) are also available in select markets outside of the U.S. Rad-97 was first CE marked in October 2016 and was later launched in India in January 2017.
See more information on the Masimo Rad-97 Pulse CO-Oximeter on Meddevicetracker.
March 21, 2017
InVivo Submits First Module of HDE Modular Submission for Neuro-Spinal Scaffold
InVivo Therapeutics announced that it has submitted its first module containing nonclinical studies to the U.S. Food and Drug Administration (FDA) as part of its Humanitarian Device Exemption (HDE) modular submission and review process for the Neuro-Spinal Scaffold, an investigational bioresorbable polymer scaffold that is designed for implantation at the site of injury within a spinal cord contusion. Following acute spinal cord injury, surgical implantation of the NeuroSpinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. InVivo’s modular HDE process is based on a submission of three modules to the FDA that constitute a complete HDE submission once all have been submitted: a nonclinical studies module, a manufacturing module, and a clinical data module. The Neuro-Spinal Scaffold received a Humanitarian Use Device (HUD) designation in April 2013 and is currently being evaluated in the INSPIRE pivotal probable benefit study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.
See more information on Neuro-Spinal Scaffold on Meddevicetracker.
ZOLL Medical Receives Health Canada Approval for ZOLL AED 3 and ZOLL AED 3 BLS
ZOLL Medical, an Asahi Kasei Group company, announced that Health Canada has approved the ZOLL AED 3 and the ZOLL AED 3 BLS (basic life support) automated external defibrillators for marketing and distribution in Canada. The ZOLL AED 3 provides enhanced Real CPR Help technology that guides rescuers through audio and visual prompts so it is clear when they are providing high-quality chest compressions. Using WiFi connectivity, the ZOLL AED 3 can connect to Program Management Onboard to enable organizations to remotely manage and monitor device readiness. The ZOLL AED 3 BLS model is designed specifically for the needs of first responders, offering critical information such as the rate and depth of each compression through the CPR Dashboard, a CPR monitoring system. Since it is WiFi-enabled, first responders can easily export clinical event data and deliver the patient record directly to health care providers. Both ZOLL AED 3 devices have the ability to treat adult and pediatric patients with a single electrode pad. The device is not yet approved in the United States
See more information on ZOLL AED 3 on Meddevicetracker.
March 22, 2017
Medtronic Receives PMA Supplemental Approval for CoreValve Evolut PRO Valve
Medtronic announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the CoreValve Evolut PRO valve and will launch immediately. The CoreValve Evolut Pro is indicated for the treatment of severe aortic stenosis for symptomatic patients who are at high or extreme risk for open heart surgery. It is a next-generation device featuring a valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to advance valve sealing performance. The biocompatible porcine pericardial tissue wrap, in addition to other design elements, is incorporated to address the occurrence of blood leaking through the sides of the valve. The Evolut PRO System is built on the Evolut R platform and is delivered through the EnVeo R Delivery Catheter System, indicated for vessels down to 5.5 mm. The approval follows new 30-day clinical data from the Evolut PRO Clinical Study that was unveiled at the American College of Cardiology (ACC) 66th Annual Scientific Session. The study met its primary endpoint at 30 days with high rates of survival (98.3 percent) and low rates of disabling stroke (1.7 percent). The Evolut PRO valve also showed strong hemodynamic performance with large aortic valve areas (2.0 ± 0.5 cm2) and mean gradients in the single digits (6.4 ± 2.1 mm Hg) at 30 days. The majority of study subjects (72.4 percent) experienced no/trace of paravalvular leaks (PVL) and no incidents of moderate or severe PVL were observed at 30 days. Evolut PRO is not available for use in countries outside of the United States.
See more information on the CoreValve Evolut R on Meddevicetracker.
Aegis Medical Receives IDE Approval to Initiate LASSO-AF Trial for Sierra Ligation System
Aegis Medical announced that it has received Investigational Device Exemption approval from the U.S. Food and Drug Administration (FDA) to initiate the LASSO-AF clinical trial in the United States for the Sierra Ligation System (formerly Sentinel Ligation System). Developed in collaboration with the Mayo Clinic, Sierra is a 3rd generation Left Arterial Appendage (LAA) closure device consisting of an epicardial suture to exclude the LAA. The Sierra procedure closes off the LAA by placing a ligature around the base of the LAA and cinching it down with a lock. Closing off the LAA from circulation prevents clots from leaving the appendage, eliminating a potential source of future stroke. The device is implemented via a single access site using electrocardiography (ECG) on the surface to navigate the placement of the device. LASSO-AF is an early feasibility study designed to assess the safety and procedural success of Sierra in closing off the left atrial appendage (LAA) using a minimally invasive, epicardial approach. Participants will be considered for this trial if their doctor(s) have determined that they have arterial fibrillation (AF), are at increased risk for developing a stroke, and are not ideal candidates for taking anticoagulation drugs. The hospital approval process has begun for the trial to take place at Mount Sinai, Mayo Clinic, Houston Methodist Hospital, and Pacific Heart Institution. The clinical trial start date in the U.S. is scheduled for May 2017.
See more information on the Sierra Ligation System on Meddevicetracker.
HTG Molecular Diagnostics Receives CE Mark Approval for HTG EdgeSeq ALKPlus Assay EU
HTG Molecular Diagnostics announced that it has obtained CE marking in the European Union for its HTG EdgeSeq ALKPlus Assay EU. The HTG EdgeSeq ALKPlus Assay EU is an in vitro diagnostic assay intended to measure and analyze mRNA ALK gene rearrangements in formalin-fixed, paraffin-embedded lung tumor specimens from patients previously diagnosed with non-small cell lung cancer (NSCLC). The assay may be used to aid in the identification of patients eligible for treatment with ALK-targeted therapeutics, such as crizotinib, an oral ATP-competitive small-molecule c-met/hepatocyte growth factor receptor (HGFR) aminopyridine tyrosine kinase and ALK-1 inhibitor. The assay is automated on the HTG EdgeSeq system using a next-generation sequencer for detection. It was developed under a partnership agreement established in October 2014 with Illumina which granted HTG the rights to develop in-vitro diagnostic test kits utilizing Illumina sequencing technology. In January 2017, HTG initiated the EdgeSeq ALKPlus Assay clinical trial for a planned pre-market approval (PMA) application for review by the U.S. Food and Drug Administration (FDA) as a companion diagnostic. HTG filed a modular PMA filing with the FDA for the EdgeSeq ALKPlus Assay in September 2016 and another in January 2017. The company expects to complete the fourth and final PMA module in early 2017.
See more information on the HTG EdgeSeq ALKPlus Assay on Meddevicetracker.
March 23, 2017
Alcon Receives PMA Supplemental Approval for AcrySof IQ ReSTOR +2.5 IOL with ACTIVEFOCUS
Alcon, a division of Novartis, announced that it received approval from the U.S. Food and Drug Administration (FDA) for its AcrySof IQ ReSTOR +2.5 Diopter (D) Multifocal Toric intraocular lens (IOL) with ACTIVEFOCUS for patients undergoing cataract surgery who choose to address their astigmatism and presbyopia at the same time. The optical design of the ACTIVEFOCUS Toric lens delivers crisp, clear distance vision and a range of vision for patients who desire less dependence on glasses. The ACTIVEFOCUS toric IOL is the only multifocal toric IOL in which the central portion is 100 percent dedicated to distance vision. Previous presbyopia-correcting IOL designs tend to compromise on distance vision in order to provide patients with a range of vision. Side effects associated with this IOL include visual disturbances such as glare, rings around lights, and blurred vision. Since the IOL corrects corneal astigmatism only when it is placed in the correct position in the eye, there is a possibility that the IOL could be placed incorrectly or could move within the eye. This may result in less improvement or a reduction in vision because the corneal astigmatism has not been fully corrected, or it may cause visual symptoms. The safety and effectiveness of the AcrySof IQ ReSTOR +2.5 D Multifocal Toric IOL has not been established in patients with certain eye conditions, such as glaucoma or diabetic retinopathy. Alcon received a PMA Supplemental Approval for the AcrySof IQ ReSTOR +2.5 D IOL in April 2015 and Japanese approval in January 2015. The AcrySof IQ ReSTOR +2.5 D IOL and AcrySof IQ ReSTOR +2.5 D IOL with ACTIVEFOCUS are approved via a supplemental Premarket Approval (PMA) application to the AcrySof ReSTOR Apodized Diffractive Posterior Chamber Intraocular Lenses, which was approved in May 2005.
See more information on the AcrySof IQ ReSTOR +2.5 D IOL with ACTIVEFOCUS on Meddevicetracker.
March 24, 2017
DexCom G5 Mobile CGM Receives Positive Medicare Reimbursement Decision
DexCom announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has published an article clarifying criteria for coverage and coding of the Dexcom G5 Mobile system, currently the only therapeutic continuous glucose monitor (CGM) under this CMS classification. The Dexcom G5 Mobile CGM system is a fully mobile CGM system for both adults and children as young as 2 years of age that sends glucose data directly to a smartphone and does not require finger pricking for testing (except for two fingers pricks per day for calibration). People covered by Medicare who have either Type I or Type II diabetes and intensively manage their insulin will now be able to obtain reimbursement. According to CMS, therapeutic CGM may be covered by Medicare when all of the following criteria are met: the beneficiary has diabetes mellitus, the beneficiary has been using a home blood glucose monitor (BGM) and performing frequent (four or more times a day) BGM testing, the beneficiary is insulin-treated with multiple daily injections (MDI) of insulin or a continuous subcutaneous insulin infusion (CSII) pump, and the patient's insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of therapeutic CGM testing results. In order to be included in this category, the system must be defined as therapeutic CGM, meaning treatment decisions can be made using the device. The device is approved via supplemental Premarket Approvals (PMA) to the Dexcom G4 Platinum CGMS, which was approved in October 2012. Dexcom received the last supplemental PMA approval for the G5 CGM in December 2016. Outside of the United States, the G5 CGM has received approval from Health Canada, CE Marking approval, and has been launched in the U.S., Europe, South Africa, and Canada.
See more information on the DexCom G5 Mobile Continuous Glucose Monitoring (CGM) System on Meddevicetracker.