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DOPTELET (avatrombopag) 

 AkaRx Inc.

INDICATION:  Treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure

ADDRESSING UNMET NEED:

  • Patients with chronic liver disease who have low platelet counts and require a procedure are at increased risk of bleeding
  • Doptelet safely increases platelet count; may decrease or eliminate platelet transfusions

MECHANISM OF ACTION:  Thrombopoietin (TPO) receptor agonist stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells resulting in an increased production of platelets

EFFICACY:

  • Two multicenter, randomized, double-blind, placebo-controlled trials, n= 435, patients with chronic liver disease and severe thrombocytopenia
  • Major efficacy outcome: Proportion of patients who did not require a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following an elective procedure.
  • Higher proportion of patients had increased platelet counts and did not require platelet transfusion or any rescue therapy with Doptelet

SAFETY:

  • Most common side effects: Fever, stomach (abdominal) pain, nausea, headache, fatigue and swelling in the hands or feet (edema);  increased risk of developing blood clots when taking Doptelet

REGULATORY PATHWAY: NDA

  • Priority review
  • Postmarketing required pediatric assessmenrs

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OSTEODETECT 

Imagen

INDICATION FOR USE: OsteoDetect analyzes wrist radiographs using machine learning techniques to identify and highlight distal radius fractures during the review of posterior-anterior (PA) and lateral (LAT) radiographs of adult wrists

ADDRESSING UNMET NEED:

  • AI algorithms have tremendous potential to help health care providers diagnose and treat medical conditions
  • Software can help providers detect wrist fractures more quickly and aid in the diagnosis of fractures

GENERIC DEVICE TYPE: Radiological Computer Assisted Detection and Diagnosis Software

  • Image processing device intended to aid in the detection, localization, and characterization of fracture, lesions, or other disease specific findings on acquired medical images (e.g. radiography, MR, CT)
  • Detects, identifies and characterizes findings based on features or information extracted from images, and provides information about the presence, location, and characteristics of the findings to the user
  • Analysis is intended to inform the primary diagnostic and patient management decisions that are made by the clinical user
  • Not intended as a replacement for a complete clinician’s review or their clinical judgment that takes into account other relevant information from the image or patient history

EFFECTIVENESS & SAFETY:

  • Retrospective study of 1,000 radiograph images that assessed the independent performance of the image analysis algorithm for detecting wrist fractures and the accuracy of the fracture localization of OsteoDetect against the performance of three board certified orthopedic hand surgeons
  • Retrospective study of 24 providers who reviewed 200 patient cases
  • Readers’ performance in detecting wrist fractures was improved using the software, including increased sensitivity, specificity, positive and negative predictive values vs. standard clinical practice

REGULATORY PATHWAY: De Novo

  • Regulation Number: 21 CFR 892.2090
  • Regulation Name: Radiological Computer Assisted Detection and Diagnosis Software
  • Regulatory Class: Class II
  • Product Code: QBS

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CUSTOMFLEX  Artificial Iris

HumanOptics AG

INDICATION FOR USE:  Iris prosthesis for the treatment of iris defects. The CustomFlex™ Artificial Iris is indicated for use in children and adults for the treatment of full or partial aniridia resulting from congenital aniridia, acquired defects, or other conditions associated with full or partial aniridia

ADDRESSING UNMET NEED:

  • Congenital aniridia is a rare genetic disorder in which the iris is completely or partially absent
  • Affects approximately 1 in 50,000 to 100,000 people in the U.S.
  • CustomFlex Artificial Iris is indicated to treat iris defects due aniridia, other reasons or conditions, such as albinism, traumatic injury or surgical removal due to melanoma

DEVICE DESCRIPTION: 

  • Foldable iris prosthesis custom-made for each individual patient
  • Manufactured from a commercially available ophthalmic silicone
  • Colorized silicone paste is applied by hand in a pattern to match the color of the natural iris using a photograph of the existing iris or, in the case of aniridia, the color of the photograph selected by the patient
  • Surgeon makes a small incision, inserts the device under the incision, unfolds it and smooths out the edges using surgical instruments
  • Prosthetic iris is held in place by the anatomical structures of the eye or, if needed, by sutures

EFFECTIVENESS & SAFETY:

  • Non-randomized clinical trial, n=389 adult and pediatric patients with aniridia or other iris defects
  • Primary Endpoint: Self-reported decrease in severe sensitivity to light and glare post-procedure, health-related quality of life, and satisfaction with the cosmetic improvement or appearance of the prosthesis
  • >70 % reported significant decreases in light sensitivity and glare as well as an improvement in health-related quality of life following the procedure
  • 94% satisfied with the artificial iris’ appearance
  • Low rates of adverse events: Device movement or dislocation, strands of device fiber in the eye, increased intraocular pressure, inflammation of the iris (iritis), adhesion of the iris to the cornea or lens (synechiae) and the need for secondary surgery to reposition, remove or replace the device

REGULATORY PATHWAY: PMA

  • Breakthrough device designation

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Image credits:  AkaRx Inc., Imagen, HumanOptics AG

 

 

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