FDA Recently Approved Devices - 海外近报 - 最新消息 - 美国华裔教授专家网 ScholarsUpdate.com

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FDA Recently Approved Devices

2021/2/16 14:03:59 ｜浏览：911 ｜评论：0

The FDA has recently approved the following devices to be marketed. Additional items can be found on the Recently Approved Devices page.

Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System - P200015

The Edwards SAPIEN 3 Transcatheter Heart Valve（THV）System with Edwards Commander Delivery System consists of a catheter-based artificial heart valve and accessories used to implant the valve without open-heart surgery. The valve is made of cow tissue attached to a balloon-expandable, cobalt-chromium frame for support.

The Edwards SAPIEN 3 THV System with Edwards Commander Delivery System was previously approved for the treatment of severe aortic stenosis（a narrowing of the aortic valve that restricts blood flow to aorta, the body's main artery）. This approval expands the indications for use to include treatment of severe pulmonary regurgitation, when blood leaks back into the heart from a leaky pulmonary valve, or pulmonary stenosis, when the pulmonary valve narrows and restricts blood flow.

LIAISON XL MUREX HBsAg Confirmatory test, LIAISON® XL MUREX Control HBsAg, LIAISON® XL MUREX Qual HBsAg - P190017

The LIAISON® XL MUREX HBsAg Qual is used to detect hepatitis B surface antigen（HBsAg）in a patient’s blood. HBsAg is a part of the hepatitis B virus（HBV）. When HBsAg is present in blood, it shows doctors that a patient has an active HBV infection, but does not show what kind of infection it is--rapidly developing（acute）or slowly developing（chronic）. If someone who previously tested positive for HbsAg now has a test that shows none, it generally means the person is recovering from the infection. The presence of HBsAg should be interpeted together with results of other hepatitis B virus serological markers, particularly the presence of antibodies against hepatitis B surface antigen, in the diagnosis of HBV infection.

This test is used with the LIAISON® XL analyzer which runs the assay and analyzes the results. The LIAISON® XL MUREX Control HBsAg Qual is used to check that the test is working properly. The LIAISON® XL MUREX HBsAg Confirmatory Test is used to confirm that HBsAg is present in blood samples after an initial test, the LIAISON® XL MUREX HBsAg Qual, result was positive.

Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System - P140031/S112

The Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve（THV）System each consists of a catheter-based artificial aortic heart valve and the accessories used to implant the valve without open-heart surgery. The valve is made of cow tissue attached to a balloon-expandable, cobalt-chromium frame for support. The SAPIEN 3 Ultra valve is a modified version of the SAPIEN 3 valve.

The Edwards SAPIEN 3 and SAPIEN 3 Ultra THV System was previously approved for the treatment of severe aortic stenosis of the patient’s own heart valve. It was also approved for the replacement of a failing（narrowed, leaky, or both）previously implanted surgical artificial aortic or mitral heart valve in patients who are too high risk for open-heart surgery. This current approval expands the indications to include the replacement of a failing（narrowed, leaky, or both）use previously implanted transcatheter aortic valve.

Simplify Cervical Artificial Disc - P200022

The Simplify Cervical Artificial Disc is an implant（device）that replaces a single disc between the vertebrae, or bones, of the neck（cervical spine areas C3 to C7）. The implant is made of two plastic endplates and a ceramic core. Each endplate is coated with titanium, which helps bone grow onto the endplates, attaching them to the vertebrae located above and below the implant.

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Revanesse® Lips+ – P160042/S010

Revanesse® Lips+ is a clear, colorless injectable gel implant（dermal filler）injected into specific areas of facial tissue. Itconsists of crosslinked hyaluronic acid（HA）made by a species of bacteria and formulated to a concentration of 22 – 28 mg/mL with 3 mg/mL of the drug lidocaine hydrochloride as a numbing agent.

This product was previously approved for injection into facial tissue to improve the appearance of smile or laugh lines（nasolabial folds）. This approval expands the use of this product to injection in the lips.

Zilver Vena Venous Self-Expanding Stent - P200023

The Zilver Vena Venous Self-Expanding Stent is intended to treat a narrowed vein found in the upper pelvic region down to the groin area（iliofemoral vein）. There are two parts：a small, spiral tube（stent）made of Nitinol（nickel-titanium）and an over-the-wire stent delivery system.

Abre Venous Self-expanding Stent System - P200026

The Abre Venous Self-expanding Stent System has two components：a metal stent made from nickel titanium（nitinol）and a stent delivery system used to place the stent in a vein. The stent system is intended to treat deep venous obstruction, which occurs when a vein located in the groin area（iliofemoral vein）becomes narrowed or blocked.

Ranger Paclitaxel-Coated PTA Balloon Catheter - P190019

The Ranger Paclitaxel-Coated PTA Balloon Catheter（Ranger DCB）uses a drug-coated balloon to re-open blocked or narrowed arteries in the thigh and knee due to peripheral artery disease （PAD）. The balloon is coated on its outer surface with paclitaxel, a drug which may help stop the arteries from narrowing again（restenosis）.

FoundationOne Liquid CDx - P200016

The FoundationOne Liquid CDx is a laboratory test designed to detect the presence of mutations in the ATM, BRCA1 and/or BRCA2 genes in circulating cell-free DNA（cfDNA）that has been isolated from whole blood plasma specimens, also called liquid biopsy specimens, from patients with（metastatic） castration resistant prostate cancer （mCRPC）. This laboratory test is a companion diagnostic that can help doctors identify if patients with mCRPC may benefit from treatment with LYNPARZA®（olaparib）.

Oncomine™ Dx Target Test - P160045/S019

The Oncomine™ Dx Target Test is a lab test designed to detect several specific genetic changes in tumors found in patients with non-small cell lung cancer and determine if certain medications may help treat the cancer. It is a type of lab test called a companion diagnostic.

The test identifies DNA changes, or mutations, in two genes, the BRAF and EGFR genes, and the rearrangement, or translocation, of chromosomes in two additional genes, ROS1 and RET using ribonucleic acid（RNA）, a chemical cousin of DNA.These specific gene changes, when present, are known to stimulate tumor growth.

This supplement expands the indications for using this test to include the detection of chromosome rearrangements, or translocations, in the gene RET.

FoundationOne® CDx - P170019/S017

FoundationOne CDx（F1CDx）is a laboratory test designed to detect genetic variations in 324 genes. F1CDx is a companion diagnostic that has been approved for the detection of genetic mutations in patients who may benefit from one of twenty-three FDA-approved therapies for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, ovarian cancer, cholangiocarcinoma, prostate cancer, and TMB for solid tumors.

This approval expands the indications for use of the F1CDx test to include an additional companion diagnostic indication for solid tumor patients who have gene rearrangements that can lead to fusions of the genes NTRK1, NTKR2, and NTRK3. Gene fusions in NTRK1, NTRK2, NTRK3, collectively referred to as NTRK gene fusions lead to fusion proteins that are both abnormally expressed and activated, resulting in activation of downstream pathways that can cause cancer. Identifying NTRK1, NTRK2, and NTRK3 gene fusions will help determine if patients with solid tumors are eligible for personalized treatment with VITRAKVI® （larotrectinib）.

Sonalleve MR-HIFU – H190003

The Sonalleve MR-HIFU uses magnetic resonance imaging （MRI）to help health care professionals deliver focused, high intensity ultrasound（sound）energy to treat osteoid osteomas, a benign painful bone tumor that usually forms in the arms or legs of children and young adults.

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