| | The FDA has recently approved the following devices to be marketed. Additional items can be found on the Recently Approved Devices page. | | | The Patient Specific Talus Spacer is an additively manufactured implant intended to match the patient's talus, a bone in the ankle joint that connects the leg and foot. The implant allows a patient with avascular necrosis (AVN) of the ankle joint to regain motion and reduce pain without an amputation or fusion until the time a fusion is necessary. The Patient Specific Talus Spacer is made from cobalt chromium metal alloy. | | | The Elecsys Anti-HBs II is a laboratory test designed to detect human antibodies against the hepatitis B virus (HBV) in a patient's blood. The presence of antibodies can help determine if a patient has been exposed to HBV or is immune to HBV. However, this test cannot determine if a patient has a recent or long-term HBV infection, or if the patient has recovered from HBV infection. The Elecsys Anti-HBs II test is used with the cobas e 601 immunoassay analyzer which runs the assay and analyzes results. The PreciControl HBs and the Anti-HBs CalCheck are used as quality control to ensure that the test is working properly. | | | TheraSphere is a radiation treatment for people who have a specific type of liver cancer called unresectable hepatocellular carcinoma (HCC). TheraSphere consists of millions of microscopic glass spheres containing yttrium-90. Yttrium-90 is used in radiation therapy to treat certain forms of cancer. The TheraSphere Yttrium-90 Glass Microsphere System contains: a sterile, single use, dose vial of TheraSphere Y-90 Glass Microspheres; a sterile, single-use TheraSphere Administration Set; and a non-sterile, re-usable TheraSphere Administration Accessory Kit. | | | ClearVisc Ophthalmic Viscosurgical Device (OVD) is a transparent thick liquid used to protect eye tissue during eye surgery, including cataract surgery. It is made with sodium hyaluronate, a chemical component that makes ClearVisc thick. Sodium hyaluronate is a type of salt naturally found inside the body. | | | The Harmony Transcatheter Pulmonary Valve (TPV) System is used to treat a leaky native or surgically repaired right ventricular outflow tract (RVOT; the part of the heart that carries blood to the lungs). The Harmony TPV System consists of a transcatheter pulmonary valve and a delivery catheter. The transcatheter pulmonary valve is made of pig heart tissue and is attached to a flexible, self-expanding nickel-titanium (Nitinol) wire frame for support. | | | The Simplify Cervical Artificial Disc is an implant (device) that replaces one or two adjacent discs 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. The Simplify Cervical Artificial Disc can now stabilize the spine after the removal of one or two adjacent damaged or diseased disc(s). An earlier version of this device was previously approved only for one damaged or diseased disc. | | | VENTANA MMR RxDx Panel is a laboratory test designed to detect mismatch repair (MMR) proteins (MSH6, PMS2, MSH2 and MLH1) in patients diagnosed with endometrial cancer. If the MMR proteins are not present, it indicates a patient with endometrial cancer is eligible for treatment with JEMPERLI (dostarlimab). This drug is used to treat recurring or advanced endometrial cancer when one or more of the MMR proteins are absent. | | | The EPi-Sense® Guided Coagulation System is a flexible surgical device used to treat long-standing persistent atrial fibrillation, an abnormal heart rhythm (arrythmia) that lasts for more than 12 months. The device is used to destroy a small area of heart tissue on the outside of the heart, called the epicardial surface, that is causing the heart to abnormally beat. | | | The TECNIS Synergy™ Intraocular Lenses (IOLs) are artificial lenses implanted in the eyes of adults to correct vision after the natural lenses have been removed due to cataracts. Cataracts, or cloudiness of the natural lens, are often the result of aging, but can have other causes. The TECNIS Synergy™ IOLs are intended to improve the ability to see far away (long distance vision). These lenses also are intended to improve the ability see at an arm's length distance (intermediate vision) such as working on a computer, applying makeup, or shaving; and at close range (near vision) such as reading, writing, and sewing. The toric version of these lenses also helps correct a cornea that has a different shape than normal (astigmatism). | | | The Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve (THV) System is a catheter-based artificial heart valve system designed to replace a diseased heart 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. This current approval expands the use of this device to include using it to replace a failing mitral valve in patients who are too high risk for open-heart surgery when the valve has already been repaired with an artificial (prosthetic) ring. The Edwards SAPIEN 3 and SAPIEN 3 Ultra THV System was previously approved for the treatment of severe aortic stenosis (narrowing of the aortic valve) of the patient's own heart valve. It was also approved for the replacement of a failing (narrowed, leaky, or both) previously implanted surgical biological aortic or mitral valve, or transcatheter aortic valve in patients who are too high risk for open-heart surgery. | | | Guardant360 CDx is a laboratory test that detects genetic mutations found in circulating cell-free DNA (cfDNA) to help 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 Guardant360 CDx test to include NSCLC patients with EGFR exon 20 insertion mutations in plasma who may benefit from treatment with RYBREVANTTM (amivantamab-vmjw). | | | JUVÉDERM® VOLBELLA® XC is a gel implant (dermal or soft tissue filler) that is injected into specific areas of facial tissue. It consists of crosslinked hyaluronic acid made by a Streptococcal species of bacteria, formulated to a concentration of 15 mg/mL with 0.3% of the drug lidocaine as a numbing agent. This product was previously approved for injection into the lips and skin around the lips to temporarily restore volume and fullness. This approval expands the use of this product to include use in the area under the eyes (infraorbital hollow) in adults over age 21. | | | |
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