FDA BRIEF: WEEK OF APRIL 4, 2016

FDA approved


 

micra

MICRA Transcatheter Pacemaker System

Medtronic, Minneapolis, Minnesota, USA

INDICATION: Patients with a heart arrhythmia called atrial fibrillation or those who have other dangerous arrhythmias, such as bradycardia-tachycardia syndrome.

UNMET MEET:

  • First pacemaker that does not require wired leads to provide an electrical connection between the pulse-generating device and the heart
  • Avoids lead malfunction, infections, pocket- and lead-related complications, dislodgements

REG. PATHWAY: PMA

DEVICE DESCRIPTION:

  • World’s smallest pacemaker
  • One inch-long, self-contained pacemaker implanted directly in right ventricle
  • Integrated delivery system : Micra Delivery Catheter, Micra Introducer

EFFECTIVENESS:

  • Single clinical trial, n=719
  • Pacing capture threshold : 98%, 6 mo. after implantation

SAFETY:

  • Complications (<7%):  Prolonged hospitalizations, deep vein thrombosis, pulmonary embolism, heart injury, device dislocation, heart attacks
  • Contraindications: Patients with implanted devices that would interfere, severely obese, intolerance to device materials, heparin

tissue

PNEUMOLINER Tissue Containment System

Advanced Surgical Concepts, Bray, Ireland

INDICATION:  Use in women without uterine fibroids undergoing hysterectomy, pre-menopausal women with fibroids- laparoscopic power morcellation appropriate therapeutic option compared to more invasive surgery. PneumoLiner device has not been proven to reduce the spread of potentially cancerous tissue during power morcellation.

UNMET NEED:

  • 1 in 350 women undergoing hysterectomy/myomectomy have uterine sarcoma
  • Morcellation risks  spread of the cancerous tissue; lowers survival
  • Need for system to contain morcellated tissue

REG. PATHWAY: De Novo

DEVICE DESCRIPTION:

  • Containment bag and a tube-like plunger to deliver the device into the abdominal cavity
  • Bag is sealed and inflated – creation of working space around tissue and visualization during morcellation

EFFECTIVENESS:

  • Tested in laboratory settings to simulate actual use and worst-case scenario
  • Containment bag impermeable to substances similar in molecular size to tissues, cells, body fluids
  • Inflated bag provided adequate space to perform morcellation with good visualization
  • Stress testing demonstrated device could withstand forces in excess of clinical use

SAFETY:

  • Contraindications: Limited patient population
  • Risks : Dissemination of morcellated tissue, injury to surrounding tissues or organs, infections, prolongation of surgical procedure
  • Required physician training

FDA continues to warn against use of laparoscopic power morcellators for removal of uterus or uterine fibroids in the vast majority of women


 

 

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