Avascular necrosis

Human medicines European public assessment report (EPAR): Aclasta, zoledronic acid, Date of authorisation: 15/04/2005, Revision: 32, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Marketing, INN, Risk, Woman, Hypercalcaemia, Menopause, Man, Cancer, Avascular necrosis, Risk management, Anatomy, Female, IIA, Osteitis, Jaw, Osteoclast, CHMP, Fever, Fracture, ATC, Pain, European, Disease, Calcium, Kidney, Paget's disease, Glucocorticoid, Neoplasm, Arthralgia, Hypocalcemia, Patient, Medical Subject Headings, Hip, Trauma, European Commission, Vitamin D, International, Language, Mouth, Select, Medicine, Paget's disease of bone, Allergy, Headache, Ibuprofen, Spine, Myalgia, Committee, Cell, Necrosis, Dietary supplement

Human medicines European public assessment report (EPAR): Aclasta, zoledronic acid, Date of authorisation: 15/04/2005, Revision: 32, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Aclasta, zoledronic acid, Date of authorisation: 15/04/2005, Revision: 32, Status: Authorised

The Inner Circle Acknowledges, Douglas R. Adams as a Pinnacle Lifetime Member for his contributions to the field of Orthopedic Surgery

Retrieved on: 
Monday, December 4, 2023
Inner circle, Orthopedic surgery, Air force, Human, Avascular necrosis, Hospital, Love, Birth, Surgeon, Ankle, Infection, Madigan Army Medical Center, Trust, Fracture, Tears, Neoplasm, AC, Army, Minimus, ABOS, University, Medical degree, Trauma, Knee, Massachusetts General Hospital, Sports medicine, Lieutenant, Brigham and Women's Hospital, Education, Dentistry, Nursing, Medicine

COLORADO SPRINGS, Colo., Dec. 4, 2023 /PRNewswire/ -- Prominently featured in The Inner Circle, Douglas R. Adams is acknowledged as a Pinnacle Lifetime Member for his contributions to the field of Orthopedic Surgery.

Key Points: 
  • COLORADO SPRINGS, Colo., Dec. 4, 2023 /PRNewswire/ -- Prominently featured in The Inner Circle, Douglas R. Adams is acknowledged as a Pinnacle Lifetime Member for his contributions to the field of Orthopedic Surgery.
  • A highly respected orthopedic surgeon, Dr. Adams is affiliated with Colorado Orthopedic Specialists, a part of the HealthONE Physician Group.
  • He is a specialist in hip arthroscopy and hip preservation surgery; sports medicine and arthroscopic surgery; and robotic total joint replacement surgery.
  • Dr. Adams noted that orthopedic surgery is a specialized branch of surgery focused on conditions related to the musculoskeletal system.

Paragon 28®, Inc. Receives FDA Approval for IDE Feasibility Study of Its SMART Total Talus™ System for use in Conjunction with the APEX 3D™ Total Ankle Replacement System

Retrieved on: 
Monday, September 11, 2023
FDA, Health, Medical Devices, Paragon, Ankle, Avascular necrosis, Foot, Multimedia, FNA, Patient, AVN, IDE, APEX, NYSE, Pharmaceutical industry, Medical device

Paragon 28, Inc. (NYSE: FNA), announced today they have received an Investigational Device Exemption (IDE) approval from the FDA to commence a feasibility study for configurations of the SMART Total Talus™ System used in conjunction with the Paragon 28® APEX 3D™ Total Ankle Replacement System.

Key Points: 
  • Paragon 28, Inc. (NYSE: FNA), announced today they have received an Investigational Device Exemption (IDE) approval from the FDA to commence a feasibility study for configurations of the SMART Total Talus™ System used in conjunction with the Paragon 28® APEX 3D™ Total Ankle Replacement System.
  • FDA approval: February 17, 2021 through an approval order for a Humanitarian Device Exception (“HDE”).
  • The IDE of the SMART Total Talus adds to the company’s existing Patient Specific Total Talus offering by expanding use of the technology as an option for prospective total ankle replacement candidates.
  • Paragon 28 acquired Additive Orthopaedics in June 2021, providing the Company with the first and only FDA approved Patient Specific Total Talus replacement for treatment of avascular necrosis (AVN).

Hip Innovation Technology Announces Positive Clinical Study Data of its Novel Reverse Hip Replacement System for the Treatment of Total Hip Arthroplasty

Retrieved on: 
Wednesday, June 28, 2023
Osteoarthritis, Bone, Obesity, University, Arthralgia, Associate professor, Roentgen, Ageing, Quality of life, BOCA, HIT, Trial of the century, Reverse, RSA, Agency for Healthcare Research and Quality, Concordia, MD, Patient, Agency, Rheumatoid arthritis, Entrepreneurship, Hospital, Roentgen stereophotogrammetry, Safety, SD, Total, Female, Medical device, Dentistry, Avascular necrosis

BOCA RATON, Fla., June 28, 2023 /PRNewswire/ --  Hip Innovation Technology, LLC (HIT), a medical device company developing innovative orthopedic device solutions to advance the quality of life and quality of care for patients, today announces the publication of one of its clinical studies. The article entitled, "Radiostereometric analysis and clinical outcomes of a novel reverse total hip system at two years," was published in the most recent issue of Bone & Joint Open journal.

Key Points: 
  • The article entitled, "Radiostereometric analysis and clinical outcomes of a novel reverse total hip system at two years," was published in the most recent issue of Bone & Joint Open journal.
  • This study enrolled 22 patients (11 male/11 female; median age 70.6 years) and evaluated implant fixation using radiostereometric analysis (RSA).
  • Hip replacement surgery, or total hip arthroplasty, is one of the most common joint replacement procedures done in the United States.
  • Total hip replacements are one of the most effective ways to reduce joint pain and improve functioning for patients with advanced hip problems.

Northwest Arkansas' First Robotic Total Knee Arthroplasty in an ASC Performed by C. Kris Hanby, M.D., of Ozark Orthopaedics

Retrieved on: 
Saturday, February 4, 2023
Knee pain, Post-traumatic arthritis, 3D ultrasound, Rheumatoid arthritis, Patient, ASC, Osteoarthritis, Avascular necrosis, Knee, Zimmer Biomet, Dentistry

ROGERS, Ark., Feb. 04, 2023 (GLOBE NEWSWIRE) -- Ozark Orthopaedics surgeon C. Kris Hanby, M.D., has officially performed the first robot-assisted Total Knee Arthroplasty in a Northwest Arkansas ASC with the Zimmer Biomet ROSA® Knee System.

Key Points: 
  • ROGERS, Ark., Feb. 04, 2023 (GLOBE NEWSWIRE) -- Ozark Orthopaedics surgeon C. Kris Hanby, M.D., has officially performed the first robot-assisted Total Knee Arthroplasty in a Northwest Arkansas ASC with the Zimmer Biomet ROSA® Knee System.
  • The procedure was performed Thursday, Jan. 19, 2023, at Precision Surgical Center of Northwest Arkansas.
  • We're the first to do it in Northwest Arkansas," stated C. Kris Hanby, M.D., a board-certified orthopaedic surgeon and joint reconstruction specialist at Ozark Orthopaedics.
  • The surgery is now offered in the ASC by all of Ozark Orthopaedics' joint replacement specialists.

Exelixis Provides Update on Phase 3 CONTACT-01 Trial Evaluating Cabozantinib in Combination with Atezolizumab in Patients with Metastatic Non-Small Cell Lung Cancer Previously Treated with Immunotherapy and Chemotherapy

Retrieved on: 
Thursday, December 8, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, ClinicalTrials.gov, Hemoptysis, Proteinuria, Fatal, Recurrence, Hepatocellular carcinoma, Bleeding, Melena, Immunotherapy, PD-L1, Union, Docetaxel, Avascular necrosis, Hypertension, Takeda Pharmaceutical Company, Hematemesis, Fistula, AST, Patient, Pulmonary embolism, ULN, Grade 3, Nivolumab, ONJ, NSCLC, Lung cancer, Venous thrombosis, Sepsis, Post-vaccination embolic and thrombotic events, Roche, Progression-free survival, HIV disease progression rates, Embolism, Nephrotic syndrome, Incidence, ALT, EXEL, VEGFR, Tablet, Survival, History, Sorafenib, DTC, Abscess, HCC, Adrenal insufficiency, Hormone replacement therapy, Perforation, RCC, Ipsen, Risk, Medical imaging, Pharmaceutical industry, Exelixis, Jaw, Takeda

Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.

Key Points: 
  • Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.
    CABOMETYX in combination with atezolizumab is not indicated as a treatment for NSCLC.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC, HCC, and DTC studies.
  • Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients.
  • Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic events that require medical intervention.

Exelixis Announces Final Overall Survival Results from Phase 3 COSMIC-312 Trial of Cabozantinib in Combination with an Immune Checkpoint Inhibitor in Patients with Previously Untreated Advanced Liver Cancer

Retrieved on: 
Monday, March 14, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Research, Liver cancer, Risk, Tablet, DTC, VEGFR, Adrenal insufficiency, EXEL, OS, Union, Proteinuria, Embolism, New Drug Application, Takeda Pharmaceutical Company, Nephrotic syndrome, History, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Melena, ONJ, Hoffmann-La Roche, AST, ALT, Hypertension, Death, Nivolumab, Pulmonary embolism, Fistula, Bleeding, Recurrence, Sepsis, Patient, Perforation, RCC, Nasdaq, Sorafenib, Abscess, Fatal, Avascular necrosis, Hormone replacement therapy, Food, Cancer, Ipsen, Progression-free survival, ClinicalTrials.gov, Hematemesis, Drug discovery, Genentech, HCC, FDA, Adult, Medical Affairs Bureau, ULN, Grade 3, Venous thrombosis, Incidence, Hemoptysis, Post-vaccination embolic and thrombotic events, Pharmaceutical industry, Jaw, Exelixis, COSMIC-312, HCC, CABOMETYX, COSMIC-312, HCC, CABOMETYX

COSMIC-312 is a global, multicenter, randomized, controlled phase 3 trial that enrolled 837 patients at 281 study centers globally.

Key Points: 
  • COSMIC-312 is a global, multicenter, randomized, controlled phase 3 trial that enrolled 837 patients at 281 study centers globally.
  • In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the U.S. and Japan.
  • Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.
    CABOMETYX is not indicated as a treatment for previously untreated advanced HCC.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC, HCC, and DTC studies.

Exelixis Announces Enrollment Completion in Phase 3 CONTACT-03 Pivotal Trial of Cabozantinib in Combination with an Immune Checkpoint Inhibitor in Previously Treated Metastatic Renal Cell Carcinoma

Retrieved on: 
Wednesday, January 5, 2022
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, ClinicalTrials.gov, MET, Renal cell carcinoma, Bleeding, Cancer, American Cancer Society, AXL, History, Neoplasm, Roche, ICI, Hormone replacement therapy, RCC, Sepsis, Hepatocellular carcinoma, AST, Avascular necrosis, Fistula, Hemoptysis, Hypertension, Progression-free survival, Hematemesis, Population, Takeda Pharmaceutical Company, Embolism, Union, Incidence, ULN, Proteinuria, Nasdaq, RECIST, Post-vaccination embolic and thrombotic events, Kidney cancer, Man, Sorafenib, DTC, Safety, Adrenal insufficiency, ONJ, Patient, HCC, Venous thrombosis, Protein, Perforation, Nephrotic syndrome, Fatal, Risk, Nivolumab, VEGF, Large-cell lung carcinoma, Growth, Tablet, Adult, ALT, Pulmonary embolism, Abscess, VEGFR, Woman, Melena, Grade 3, EXEL, Recurrence, Ipsen, Pharmaceutical industry, Medical imaging, Exelixis, Jaw, RCC, CABOMETYX, RCC, CABOMETYX

Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.

Key Points: 
  • Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.
    CABOMETYX in combination with atezolizumab is not indicated for metastatic RCC.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC, HCC, and DTC studies.
  • The von Hippel-Lindau tumor suppressor gene inhibits hepatocyte growth factor/scatter factor-induced invasion and branching morphogenesis in renal carcinoma cells.
  • Markedly increased amounts of messenger RNAs for vascular endothelial growth factor and placenta growth factor in renal cell carcinoma associated with angiogenesis.

Paragon 28’s Patient Specific Titanium Talus Spacer Has Been Approved by the U.S. Food and Drug Administration

Retrieved on: 
Monday, December 13, 2021
FDA, Health, Surgery, Medical Devices, Paragon, Digital, Charcot foot, Food, Ankle, Solution, FDA, P28, Bunion, Chicken feet, Humanitarian Device Exemption, NYSE, APEX, Trauma, Amputation, Patient Specific Talus Spacer, FNA, Talus, Foot, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Avascular necrosis, CEO, Patient, Leg, Quality of life, Arthritis, Surgeon, Recurrence, MBA, MD, Partnership, Orthopedic surgery, Titanium, Cobalt, Duke University, Medical device

Paragon 28, Inc. (NYSE: FNA ) announced today that it has received a supplemental approval order from the U.S. Food and Drug Administration ("FDA") for the Patient Specific Talus Spacer.

Key Points: 
  • Paragon 28, Inc. (NYSE: FNA ) announced today that it has received a supplemental approval order from the U.S. Food and Drug Administration ("FDA") for the Patient Specific Talus Spacer.
  • The supplemental approval order allows the Patient Specific Talus Spacer to be additively manufactured in titanium alloy with a titanium nitride coating.
  • The Patient Specific Talus Spacer was first approved on February 17, 2021, by the FDA under a Humanitarian Device Exemption for treatment of avascular necrosis of the ankle joint.
  • The Patient Specific Talus Spacer remains the first and only patient specific total talus replacement implant authorized for use in the United States.

Exelixis Announces Enrollment Completion in Phase 3 CONTACT-01 Pivotal Trial of Cabozantinib in Combination with an Immune Checkpoint Inhibitor in Previously Treated Metastatic Non-Small Cell Lung Cancer

Retrieved on: 
Tuesday, November 9, 2021
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Population, Venous thrombosis, Progression-free survival, Ipsen, Cancer, Lung cancer, Adenocarcinoma, ULN, Avascular necrosis, Squamous cell carcinoma, Sorafenib, Hypertension, Adrenal insufficiency, Takeda Pharmaceutical Company, Grade 3, Post-vaccination embolic and thrombotic events, Recurrence, VEGFR, European Union, Fistula, Disease, Roche, Hematemesis, Proteinuria, RCC, Abscess, Union, Perforation, Nivolumab, Hormone replacement therapy, Immunotherapy, Fatal, HIV disease progression rates, Sepsis, Bleeding, Hepatocellular carcinoma, Woman, Docetaxel, ALT, DTC, Incidence, AST, Hemoptysis, ClinicalTrials.gov, Large-cell lung carcinoma, Melena, History, ONJ, EXEL, NSCLC, Pulmonary embolism, Nephrotic syndrome, Tablet, HCC, Survival, Nasdaq, Patient, Risk, Embolism, Man, Adult, Pharmaceutical industry, Medical imaging, NSCLC, CABOMETYX, NSCLC, CABOMETYX

In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the U.S. and Japan.

Key Points: 
  • In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the U.S. and Japan.
  • Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.
    CABOMETYX is not indicated as a treatment for metastatic NSCLC.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC, HCC, and DTC studies.
  • Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients.