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| FDA：Recently Approved Devices（06/29/2022） |
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| 2022/7/1 16:37:04 ｜ 浏览：1016 ｜ 评论：0 |
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Recently Approved Devices
U.S. Food and Drug Administration sent this bulletin at 06/29/2022 10:33 AM EDT
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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.
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Guardant360 CDx is a laboratory test designed to detect gene mutations found in circulating cell-free DNA（cfDNA）to help doctors identify patients with non-small cell lung cancer（NSCLC）who may benefit from specific FDA-approved treatments. This approval expands the indications for use of the Guardant360 CDx test to include an additional mutation（KRAS G12C）as a target for treatment options for NSCLC patients. For patients with the KRAS G12C genetic mutation, this test may help identify if treatment with the drug LUMAKRAS（sotorasib）will be appropriate.
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The therascreen KRAS RGQ PCR Kit is a laboratory test that detects seven mutations found in the KRAS gene of non-small cell lung cancer and colorectal cancer to help doctors identify patients with these cancers who may benefit from specific FDA-approved treatments. This approval expands the indications for use of the therascreen KRAS RGQ PCR Kit to include patients with non-small cell lung cancer who may benefit from treatment with LUMAKRAS（sotorasib）. | |
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The Arctic Front Advance and Arctic Front Advance Pro Cardiac Cryoablation Catheters are balloon-tipped catheters that use cold energy to treat an abnormal heart rhythm that causes fast and irregular heartbeats（atrial fibrillation）. The Freezor MAX Cardiac Cryoablation Catheter is a secondary catheter that uses the same cold energy to treat parts of the heart that the balloon-tipped catheter cannot reach. This approval expands the indications for use to also treat patients with symptomatic paroxysmal AF who have not been previously treated with medicine（drug naïve）for preventing AF episodes from occurring again. The FDA previously approved these catheters to treat patients with intermittent AF episodes（paroxysmal AF）or continuous AF episodes（persistent AF）lasting up to six months in duration that cause symptoms（symptomatic）and do not respond to medicine（drug refractory）. | |
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The Neuro Cochlear Implant System is intended to provide the user with hearing sensation through electrical stimulation of the hearing nerve（auditory nerve）. The system consists of an external component, which sits behind the ear and internal components, including a receiver that is surgically placed under the skin of the patient and an electrode array that is inserted to the inner ear. | |
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The XIENCE family of Everolimus Eluting Coronary Stent Systems（XIENCE Alpine EECSS, XIENCE Sierra EECSS, XIENCE Skypoint EECSS）is intended to treat a narrowed blood vessel（coronary artery）caused by coronary artery disease. Each system consists of a cobalt chromium alloy metal stent and a catheter delivery system. The stent is coated with the drug everolimus and a polymer（PBMA and PVDF-HFP）coating to help deliver the drug at a controlled rate. This approval expands the indications for use to include patients at high risk for bleeding. | |
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Restylane Contour is a gel implant（dermal filler）injected into specific areas of facial tissue. It consists of crosslinked hyaluronic acid made by a species of Streptococcal bacteria and formulated to a concentration of 20 mg/mL with 3 mg/mL of the drug lidocaine hydrochloride as a numbing agent. | |
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The ADVIA Centaur Anti-HBe2 is a laboratory test used to detect human antibodies against the hepatitis B virus e-antigen（HBeAg）in a patient’s blood. Detection of anti-HBe antibodies in a patient’s bloodstream indicates e-antigen seroconversion of the hepatitis B virus（HBV）. This may occur in patients with recent（acute）or long-term（chronic）HBV infection. | |
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The FoundationOne Liquid CDx assay is a laboratory test designed to find a number of different mutations in circulating cell-free DNA（cfDNA）. This test helps doctors identify patients with non-small cell lung cancer who may benefit from specific FDA-approved treatments. This approval expands the indications for use of the FoundationOne Liquid CDx test to include patients who have non-small cell lung cancer（NSCLC）, a type of lung cancer, with certain genetic mutations in the MET gene of their tumors. Identifying these changes will help patients with lung cancer get personalized treatment with TABRECTA®（capmatinib）. | |
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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 to include lower limb pain associated with diabetic neuropathy, also known as painful diabetic neuropathy. | |
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The ASSURE Wearable Cardioverter Defibrillator System continuously monitors and automatically detects abnormal heart rhythm caused by the heart’s pumping chambers（ventricular arrythmia）. If necessary, it may deliver an electric “shock" from the defibrillator to restore the heart’s normal rhythm（defibrillation）. The ASSURE system is worn outside the body（external）and works without additional action from the patient or from bystanders. *Each style has seven sizes available. | |
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The RelayPro Thoracic Stent-Graft System is designed to repair a weakened and bulging（aneurysm）section of the largest artery in the body（aorta）in the area behind the heart（descending thoracic aorta）. The system consists of a delivery catheter and tube-shaped implants（stent grafts）made of nitinol, polyester, and platinum-iridium. The system has two types of implants, the proximal bare stent, and the non-bare stent（NBS）configurations. | |
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The Amplatzer Amulet Left Atrial Appendage Occluder（LAAO）is a permanent implant that is placed in the patient’s left atrial appendage（LAA）, which is a pouch-like part of the heart. The device is intended to prevent blood clots formed in the LAA from entering the bloodstream and potentially causing a stroke. The device is made of a Nitinol（nickel-titanium）mesh with polyester fabric cover. | |
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The VENTANA MMR RxDx Panel is a laboratory test designed to detect mismatch repair（MMR）proteins（MSH6, PMS2, MSH2 and MLH1）in patients diagnosed with solid tumors that have reoccurred multiple times（recurrent）or those who have advanced solid tumor growth. If the MMR proteins are not present, it indicates a patient with recurring or advanced solid tumors is eligible for treatment with JEMPERLI（dostarlimab‐gxly）. | |
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The Oncomine Dx Target Test is a laboratory test designed to detect the presence of mutations within a specific gene in patients who have cancer. This test helps doctors identify patients with cholangiocarcinoma who may benefit from specific FDA-approved treatments. This approval expands the indications for use of the Oncomine Dx Target Test to include the detection of mutations to IDH1 in patients with cholangiocarcinoma（bile duct cancer）. Identifying these mutations will help patients with cholangiocarcinoma patients to get personalized treatment with TIBSOVO（ivosidenib）. | |
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The RADIESSE（+）Lidocaine Injectable Implant is a gel implant, or dermal filler used in specific areas of facial tissue to reduce the appearance of lines and wrinkles. It consists of the chemical calcium hydroxylapatite（CaHa）and 0.3%（weight by volume, or w/v）of the drug lidocaine hydrochloride as a numbing agent. This approval expands the indications for use of the RADIESSE（+）Lidocaine Injectable Implant to include injection into deep layers of the facial tissue（subdermal and/or supra-periosteal）to improve the outline（contour）of the jawline. | |
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The TransMedics Organ Care System（OCS）Heart System is designed to preserve donor hearts prior to transplantation. This system includes a portable enclosure designed to warm the donor heart and,provide it with oxygen and nutrients, as well as a heart preservation solution. | |
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The Oncomine Dx Target Test is a laboratory test designed to detect the presence of mutations within a specific gene in patients who have cancer. This test helps doctors identify patients with non-small cell lung cancer（NSCLC）and cholangiocarcinoma who may benefit from specific FDA-approved treatments. This approval expands the indications for use of the Oncomine Dx Target Test to include the detection of EGFR exon 20 insertion mutations in patients with NSCLC. Identifying EGFR exon 20 insertion mutations will help NSCLC patients to get personalized treatment with EXKIVITY（mobocertinib）. | |
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The Portico Transcatheter Aortic Valve Implantation System is an artificial aortic heart valve replacement system that can be used without the need for an open-heart surgery. This implantation system consists of an artificial aortic heart valve and a delivery system（called the FlexNav Delivery System）. The valve is made of natural tissue obtained from the hearts of cows and pigs that is attached to a self-expandable metal（nickel-titanium）frame for support. | |
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ConMed PadPro multifunction electrodes（MFEs）are a set of sensors that are attached to a compatible defibrillator and then placed on a person experiencing cardiac arrest to detect and help correct irregular heartbeats. ConMed PadPro multifunction electrode adapters are a reusable accessory that provide an additional connector type for use with compatible defibrillator brands and models. | |
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The TransMedics Organ Care System（OCS）Liver is designed to preserve donor livers prior to transplantation. This system includes a portable enclosure designed to warm the donor liver, provide it with oxygen, nutrients, and blood, and collect bile from the donor liver. | | |
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