Fda sir-sphere

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August undefined, 2024

WebA randomized, multicenter, investigator sponsored phase II trial comparing the clinical outcomes of SIRT with TheraSphere in patients with intermediate/advanced HCC using two pre-treatment dosimetry determination methods: (1) Standard, single-compartment dosimetry (SDA); defined as a uniform distribution of absorbed dose within the perfused … WebK120615-081 2 Rev. 1 (03/2024) 1 2 DEVICE DESCRIPTION . The TheraSphere Yttrium-90 (Y-90) Glass Microsphere System consists of: • a sterile, single use, dose vial of TheraSphere,Y-90 Glass Microspheres,available in 3 GBq – 20 GBq

FDA approves TheraSphere Y-90 glass microspheres

WebSIR-Spheres@ is indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of … WebSep 15, 2024 · In the U.S., SIR-Spheres Y-90 resin microspheres have a Pre-Market Approval (PMA) from the FDA and are indicated for the treatment of unresectable metastatic liver tumors from primary colorectal ... stand up paddle board tybee island

SorAfenib Versus RADIOEMBOLIZATION in Advanced …

WebJul 8, 2013 · This phase I trial aims to establish, first, the tolerability of the combination of liver radioembolization with SirSpheres® and sorafenib in uveal melanoma patients with liver metastasis studying different schedules of administration of sorafenib after and before radioembolization. WebJan 18, 2024 · Phase II Randomized Study of SIR-Spheres, Yttrium Microspheres With Cetuximab Plus Irinotecan for Patients With Advanced Colorectal Cancer Metastases to the Liver : Secondary IDs: Study Status. Record Verification: October 2010 : Overall Status: Recruiting: Study Start: October 2009 WebFood and Drug Administration person locator for free

Rx only Instructions for Use TheraSphere™ Yttrium-90 Glass …

Food and Drug Administration

WebOct 23, 2015 · SIR-Spheres Y-90 resin microspheres are administered through a small catheter and inserted into the femoral artery. SIR-Spheres Y-90 resin microspheres are an FDA approved medical device intended for the treatment of colorectal cancer that has spread to the liver and cannot be surgically removed. WebThe FDA-approved product labeling for SIR-Sphere’s states that resectability may be evaluated via imaging with a triple phase contrast angio-portal CT scan or magnetic resonance imaging (MRI). The FDA-approved labeling for SIR-Sphere states that the following tests are recommended before treatment: person looking at the skyWebThe SIR is intended to facilitate interaction between FDA and the submitter to quickly resolve or clarify issues identified in these letters so that projects can move forward, and … stand up paddle board wiki

"WebMar 18, 2024 · FDA approval has been granted to the TheraSphere Y-90 Glass Microspheres for the treatment of unresectable hepatocellular carcinoma (HCC), … " - Fda sir-sphere

Fda sir-sphere

FDA Approval Insights: TheraSphere Y-90 Glass Microspheres …

WebDec 7, 2024 · The Design History File (DHF) is a collection of documents that outlines the design history of a medical device. A DHF is one of the first documents that a regulatory body such as the FDA inspects for accrediting purposes. The primary function of the DHF is to provide documented evidence that the device’s design phase is following the ... WebK120615-081 2 Rev. 1 (03/2024) 1 2 DEVICE DESCRIPTION . The TheraSphere Yttrium-90 (Y-90) Glass Microsphere System consists of: • a sterile, single use, dose vial of …

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WebMar 22, 2024 · SIR-Spheres Y-90 resin microspheres are a medical device used in an interventional radiology procedure known as selective internal radiation therapy (SIRT), … WebJul 8, 2013 · This phase I trial aims to establish, first, the tolerability of the combination of liver radioembolization with SirSpheres® and sorafenib in uveal melanoma patients with …

WebSIR-Spheres will have the following indication for use: SIR-Spheres Y 90 resin microspheres are indicated for the treatment of unresectable hepatocellular carcinoma … WebAPPROVAL FOR SIR-SPHERES. THE DEVICE IS INDICATED FOR THE TREATMENT OF UNRESECTABLE METASTATIC LIVER TUMORS FROM PRIMARY COLORECTAL …

WebSIR-Sphere: Study Arm (s) Active Comparator: sorafenib group Patients will receive continuous oral treatment with 800 mg of sorafenib daily (Nexavar, Bayer HealthCare Pharmaceuticals-Onyx Pharmaceuticals). Treatment interruptions and dose reductions (to 400 mg once daily) will be permitted for drug-related adverse effects. WebPrecise Dosimetry. Drawing up customized dose enables personalized and precise patient treatment. *On average, there are 44 million spheres in each SIR-Spheres® Y-90 resin …

WebThe FDA Acronyms and Abbreviations database provides a quick reference to acronyms and abbreviations related to Food and Drug Administration (FDA) activities. The emphasis is on scientific,...

Webradioactive drug producer (30.34), or equivalent Agreement State requirements, or – Preparedby an ANP, or an AU who meets 35.290 or § § 35.390 with generator elution … stand up paddle board wheelsWebNov 30, 2011 · Drug: SIR-Sphere The first step will check patient eligibility and prepare conditioning by performing selective mesenteric and hepatic angiography (to document … stand up paddleboard wall rackWebApr 27, 2024 · What are the SIR-Spheres microspheres? Methods: Currently, there are two commercially available microspheres approved by the FDA, SIR-spheres and TheraSpheres. SIR-Sphere consists of resin microspheres coated with Y-90 while TheraSphere contains insoluble glass microspheres with Y-90 as an intricate part of the … person looking away from cameraWebU.S. Food & Drug Administration 10903 New Hampshire Avenue Doc ID# 04017.04.18 Silver Spring, MD 20993 www.fda.gov Sirtex Medical US Holdings, Inc. October 23, 2024 ... SIR-Spheres Microspheres Activity Calculator (SMAC) Indications for Use (Describe) The SIR-Spheres® Microspheres Activity Calculator (SMAC) is intended as a tool to assist … person looking at the groundWebSIR sphere radioactive source -Yttrium is a beta emitter -The dose travels an average of 2.5 mm in tissue -Yttrium has a half-life of 64 hours -94% of the dose is delivered to the tumor in just over 11 days The use of SIR sphere technology is reffered to as SIRT (Selective internal radiation therapy) - also called radioembolization person looking behind themWebMar 19, 2024 · Boston Scientific receives FDA approval for TheraSphere Y-90 glass microspheres 19th March 2024 9220 The US Food and Drug Administration (FDA) have granted approval of the TheraSphere Y-90 glass microspheres ( Boston Scientific ), developed for the treatment of patients with hepatocellular carcinoma (HCC). stand up paddle board with sailWebU.S. Food & Drug Administration 10903 New Hampshire Avenue Doc ID# 04017.04.18 Silver Spring, MD 20993 www.fda.gov Sirtex Medical US Holdings, Inc. October 23, … person looking down at phone