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The FDA has recently approved the following devices to be marketed. Additional items can be found on the Recently Approved Devices page. | | | The SoftVue Automated Whole Breast Ultrasound System with Sequr Breast Interface Assembly (SoftVue System) is a medical device for three-dimensional, automated ultrasound scanning of the whole breast of patients with dense tissue. | | | The Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is a laboratory test designed to identify if a patient with early breast cancer (EBC) has the protein called Ki-67 in their cancer. The laboratory test is a companion diagnostic that can help doctors identify if patients with early breast cancer have the protein Ki-67 may benefit from treatment with the drug abemaciclib combined with standard additional endocrine therapy. | | | The Spatz3 Adjustable Balloon is a weight-loss device that is filled with saline and implanted in the stomach for up to eight months. | | | The VENTANA PD-L1 (SP263) Assay is a laboratory test designed to identify if patients with non-small cell lung cancer (NSCLC) have programmed cell death ligand (PD-L1) in their cancer. Patients with a positive test result from this test can benefit from the drug TECENTRIQ (atezolizumab). | | | The Vercise™ PC, Vercise Gevia™ and Vercise Genus™ DBS Systems are implantable devices that deliver low-intensity electrical pulses to nerve centers in the brain using different combinations of amplitude (intensity), pulse width (time between start and stop of pulse), and frequency (number of pulses over time). These DBS systems consist of the following components: an implantable pulse generator (IPG) (non-rechargeable or rechargeable); a clinician programmer; a patient controller; and a lead kit and extension kit. This supplement expands the indications for use of these devices to include an additional option for patients who are diagnosed with essential tremor or tremor due to Parkinsonian's Disease not adequately controlled by medication and where the tremor accounts for a significant disability that interferes with daily activities. | | | The Exablate Model 4000 Type 1.0 and 1.1 System (Exablate Neuro) is a magnetic resonance image-guided focused ultrasound (MRgFUS) system that treats tremors that cannot be controlled using medication alone in essential tremor and tremor-dominant Parkinson's disease patients by destroying areas of brain tissue. This approval expands the indications for use of the Exablate Neuro to include use of this device in the unilateral pallidotomy of medication-resistant Parkinson's disease patients with moderate to severe motor complications as a supplement to medication treatment. | | | The Optilume® Urethral Drug Coated Balloon (DCB) uses a drug-coated balloon attached to the end of a urethral catheter to expand the urethra, that may be abnormally narrowed (stricture). The balloon is coated on its outer surface with paclitaxel, a drug that may help preserve the expansion of the stricture and maintain improved urinary flow. | | | The 4Kscore Test is an in vitro diagnostic test system designed to evaluate a patient's likelihood of aggressive prostate cancer by measuring concentrations of four proteins (total PSA, free PSA, intact PSA, and kallikrein 2) in a patient's blood sample, along with a patient's age, previous biopsy, and digital rectal exam results. | | | The OrganOx metra® System is designed to transport and preserve donor livers prior to transplantation. The system has three main components: a reusable base unit that contains software, hardware, and a trolley or hardcover; a sterilized, single use, disposable fluid management circuit; and the solutions required for perfusion. | | | The Svelte Family of Sirolimus-Eluting Coronary Stent Systems (Svelte DES) is intended to treat a narrowed blood vessel (coronary artery) caused by coronary artery disease. Both systems consist of a cobalt-chromium alloy metal stent covered with the drug sirolimus and a bioresorbable polymer (PEA) coating and a catheter delivery system. | | | The Scoreflex NC Scoring PTCA Catheter is intended to open narrowed or blocked arteries in the heart with the use of a balloon catheter and a scoring wire (see Figure 1). | | | RHA Redensity is a gel implant or dermal filler that is injected in specific areas of facial tissue to reduce the appearance of lines and wrinkles. It consists of the chemical sodium Hyaluronic Acid (NaHA), 1,4-butanediol diglycidyl ether (BDDE) and 0.3% of the drug lidocaine hydrochloride to reduce pain on injection. This approval is for the correction of moderate to severe vertical wrinkles around the mouth (dynamic perioral rhytids). | | | The Nucleus 24 Cochlear Implant System is an implant that gives a person access to sound by directly stimulating the hearing nerve (auditory nerve). The cochlear implant system consists of an internal and an external component. The Nucleus 24 Cochlear Implant System was previously approved for use in people ages 9 months and older with severe to profound sensorineural hearing loss in both ears. This approval expands the use for this device to include people ages 5 years and older with severe to profound hearing loss in one ear (single-sided deafness/unilateral hearing loss (SSD/UHL)) and normal hearing or mild hearing loss in the other ear. | | | The Prometra® Programmable Infusion Pump System is a permanently implanted battery-operated programmable infusion pump that delivers medicine directly into the fluid-filled space around the spinal cord, called the intrathecal space. The Prometra® Programmable Infusion Pump System includes a pump, programmer and catheter. The Prometra® Pump System was previously approved for the intrathecal infusion of Infumorph, 0.9% Saline, and intrathecal Baclofen in adult patients. This approval expands indications for use to include the intrathecal infusion of Baclofen in patients ages 12 and older. | | | The Senza Spinal Cord Stimulation (SCS) system is an implanted, rechargeable spinal cord stimulation system intended to treat long-term (chronic) pain in the trunk or limbs that is difficult to manage (intractable). The main components of the SCS system include an implanted signal generator that is connected to one or two implanted leads and a remote control that can turn the stimulator ON or OFF to allow adjustments of therapy settings. This supplement expands the Senza SCS systems' Indications for Use when programmed to a frequency of 10 kHz, to aid in the management of intractable back pain when the patient is not a candidate for back surgery, and back surgery hasn't been performed previously. | | | The Eversense E3 Continuous Glucose Monitoring (CGM) System gives real-time blood sugar (glucose) readings every five minutes for people with diabetes. The system consists of an implantable fluorescence-based sensor, a transmitter, and a mobile app for displaying glucose values, trends and alerts on the patient's compatible mobile device (smart phone, tablet, etc.). This approval allows for the new version of the sensor to be worn for up to 180 days. Previous versions of the sensor were approved by the FDA for only 90 days of wear. | | | FoundationOne CDx is a laboratory test designed to find genetic variations in 324 genes as well as some specific gene rearrangements and other biomarkers, including microsatellite instability (MSI), in the genomic makeup of a tumor. Microsatellite instability is a change or mutation that occurs in some cancer cells where a short, repeated sequence of DNA (microsatellite) in the cell does not repeat exactly the same way. FoundationOne CDx is a companion diagnostic, or test used to help match a patient to a specific drug or therapy. It was originally approved to find genetic mutations in patients that help decide if they will benefit from one of 15 FDA-approved therapies for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, and ovarian cancer. This approval expands the indications for use of the FoundationOne CDx test to include patients with solid tumor cells that have a high level of microsatellite instability (MSI-H status). Identifying tumors with MSI-H status may help doctors determine if a patient will benefit from treatment with KEYTRUDA (pembrolizumab). | | | The CardioMEMS HF System wirelessly measures and monitors pulmonary artery (PA) pressure and heart rate for patients with heart failure. The system consists of an implantable pulmonary artery (PA) sensor, delivery system, and patient electronics system. | | | The Evoke Spinal Cord Stimulation (SCS) System (Evoke System) is an implanted, rechargeable spinal cord stimulation system intended to treat long-term (chronic) pain in the trunk or limbs that is difficult to manage (intractable). The main components of the Evoke System include an implanted signal generator that is connected to one or two implanted leads and a remote control that can turn the stimulator ON or OFF to allow adjustments of therapy settings. | | | The eCoin Peripheral Neurostimulator System generates electrical pulses to help stimulate nerves related to bladder control in people with urgency urinary incontinence, or a sudden urge to urinate that causes some urine to leak out. The device is implanted under the skin near the ankle and is controlled by a healthcare provider using a remote control. | | | |
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