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ZILRETTA (triamcinolone acetonide extended-release injectable
suspension), for intra-articular use

Flexion Therapeutics, Inc.

INDICATION: For the management of osteoarthritis pain of the knee.
Limitation of Use: Not intended for repeat administration

ADDRESSING UNMET NEED: Non-opioid therapy for pain

REGULATORY PATHWAY: NDA,  505(b)(2)

MECHANISM OF ACTION: Corticosteroid with anti-inflammatory and immunomodulating properties; activates glucocorticoid receptor, leading to activation of anti-inflammatory transcription factors

EFFICACY:

  • Multi-center, international, randomized, double-blind, parallel-arm, placebo- and active-controlled  (immediate release formulation) study in patients (n=484)  with osteoarthritis pain of knee, followup for 24 weeks
  • Primary efficacy endpoint:  Average Daily Pain intensity scores (ADP) as assessed by a 0-10 Numeric Rating Scale
  • Statistically significant reduction in pain intensity vs. placebo
  • Statistical significance not demonstrated vs. immediate-release formulation

SAFETY:

  • Serious adverse events: Neurologic adverse reactions with epidural and intrathecal administration, joint infection and damage, increased risk of infections, alterations in endocrine function, cardiovascular effects, renal effects, increased intraocular pressure, gastrointestinal perforation, alternations in bone density, behavioral and mood disturbances

LABEL


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SENHANCE Surgical Robotic System

TransEnterix Surgical Inc

USE: Intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization and retraction in laparoscopic colorectal surgery and laparoscopic gynecological surgery. The system is for use on adult patients by trained physicians in an operating room environment

ADDRESSING UNMET NEED: 

  • New robotically-assisted surgical device (RASD) for minimally invasive surgery
  • Minimally invasive surgery helps reduce pain, scarring and recovery time
  • RASD technology enhances surgeon’s access and visualization within confined operative sites

REGULATORY PATHWAY: 510(k)

  • Predicate Device: da Vinci Si IS3000 device for gynecological and colorectal procedures
  • Device Classification Name:  System,Surgical,Computer Controlled Instrument
  • Regulation Description: Endoscope and Accessories
  • Regulatory Class: Class II
  • Classification Product Code: NAY, GCJ
  • Regulation Number: 876.1500

DESCRIPTION:

  • Type of computer-assisted surgical system
  • Provides surgeons with console unit that provides a 3-D high-definition view of  surgical field
  • Allows control of three separate robotic arms remotely
  • End of each arm equipped with surgical instruments based on traditional laparoscopic instrument designs
  • Unique technological characteristics
    • Force feedback: Helps surgeon “feel” stiffness of tissue being grasped
    • Eye-tracking: To control movement of surgical tools and laparoscopic-type
  • Not a robot because it cannot perform surgery without direct human control

EFFECTIVENESS AND SAFETY:

  • Use of Real-World Evidence (RWE) 
    • Clinical study, n=150 patients undergoing various gynecological operations
    • Outcomes compared to RWE from 8,000 gynecological operations described in eight peer-reviewed publications using another RASD
  • Operative Results in Real-World Setting
    • Clinical study, n=45 patients undergoing colorectal procedures
    • Outcomes compared to RWE from peer-reviewed research publications
  • Performance testing
    • Simulated use and worst-case scenario conditions vs Predicate Device

 MAGNETOM TERRA system

Siemens Medical Solutions Inc.

INDICATION FOR USE: As a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal, and oblique cross-sectional images and that displays the internal structure and/or function of head and extremities. Other physical parameters derived from the images may also be produced. These images and physical parameters derived from the images when interpreted by a trained physician yield information that may assist in diagnosis. Intended for patients > 30 kg (66 lbs)

ADDRESSING UNMET NEED: 

  • First seven tesla (7T) MRI device, more than doubling the static magnetic field strength available for use in the US (Average 3T)
  • Improved image quality, better visualization of smaller structures and subtle pathologies that may improve disease diagnosis

REGULATORY PATHWAY: 510(k)

  • Regulation Name: Magnetic Resonance Diagnostic Device
  • Regulatory Class: Class II
  • Product Code: LNH, LNI, MOS
  • Regulation Number: 21 CFR 892.1000

EFFECTIVENESS AND SAFETY:

  • Comparative study, n=35 healthy patients, images using 7T device vs. 3T device
  • Board-certified radiologists confirmation that 7T images were of diagnostic quality and potentially improvement over 3T
  • Safety of  subsystem through computational modeling, simulations and rigorous experimental validation

Image credits: Flexion, TransEnterix, Siemens

 

 

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