FDA Approvals & Consumer Information: AERA system, VISUMAX Laser, BARD stent, COBAS test, IMAGE READY system, JUVEDERM Volbella, RAINDROP inlay, OBALON Balloon – Drug and Device Digest

FDA BRIEF: Week of September 12, 2016

FDA approved


AERA Eustachian Tube Balloon Dilation System

Acclarent, Inc., Irvine, CA, USA

Image result for Aera Eustachian Tube

INDICATION FOR USE: To treat persistent Eustachian tube dysfunction (ETD), a condition in which pressure, pain or clogged or muffled sensations occur in the ear.


  • Eustachian tube supports hearing by maintaining pressure inside the ear
  • ETD results in discomfort, impaired hearing, persistent ear infections, ringing in the ears (tinnitus) or other symptoms
  • Need for new treatment option for ETD

REG PATHWAY: De Novo classification process


  • Catheter to insert a small balloon through the patient’s nose and into the Eustachian tube
  • Once inflated, balloon opens up pathway for mucus and air to flow through the Eustachian tube
  • After Eustachian tube dilated, doctor deflates and removes the balloon.


  • Randomized clinical trial, n=299, patients with chronic ETD, Aera vs. conventional medical management (nasal spray).
  • Primary Endpoint: Middle ear function was tested using tympanogram, 6 weeks post-procedure
    •  52%  with tympanogram results within a normal functioning vs. 14%
  • Most common adverse event: Small tears of the lining of the Eustachian tube, minor bleeding and worsening of ETD


VISUMAX  Femtosecond Laser 

Carl Zeiss Meditec Inc., Dublin, CA, USA

Picture of the device.

INDICATION FOR USE: For the small incision lenticule extraction (SMILE) procedure to reduce or eliminate nearsightedness in certain patients 22 years of age or older.


  • Nearsightedness, or myopia, is a common vision condition
  • Can be due to the shape of the cornea being too steep and/or the length of the eyeball being too long
  • Need for expansion of surgical treatment options available to patients for correcting nearsightedness



  • Laser removes small amount of eye tissue to permanently reshape cornea
  • Femtosecond (very fast, short-pulsed) laser makes cuts within cornea, creating disc-shaped piece of tissue  removed by surgeon
  • Tissue removal causes changed shape of cornea, corrects nearsightedness


  • Clinical study, n=328,
  • Primary endpoint :  Stable vision correction at six month
  • >99% :Uncorrected (without glasses or contacts) visual acuity of 20/40 or better
  • 88% : Uncorrected visual acuity of 20/20 or better
  • Common complications during surgery: Difficulty removing corneal tissue, loss of suction that keeps laser aligned with eye
  • Common complications after surgery: Debris at the site of tissue removal, dry eye, moderate to severe glare and moderate to severe halos




BARD ® LifeStent® Vascular Stent System

Bard Peripheral Vascular, Inc.Tempe, AZ, USA

Image of the device.

INDICATION FOR USE: T is intended to improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and popliteal artery with reference vessel diameters ranging from 4.0 – 6.5 mm.

Consumer Information

COBAS ® EGFR Mutation Test v2
Roche Molecular Systems, Inc., Pleasanton, CA, USA

cobas® EGFR Mutation Test v2

INDICATION FOR USE: Real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood. The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies  in accordance with the approved therapeutic product labeling:

Consumer Information

ImageReady MR Conditional Pacing System and Ingevity Pace/Sense Lead
Boston Scientific Corporation, St. Paul, MN, USA


ImageReady MR Conditional Pacing System

INDICAIONS FOR USE: Symptomatic paroxysmal or permanent second- or third-degree AV block ,  Symptomatic bilateral bundle branch block, Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial [SA] block), Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias,  Neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes

Consumer Information

Allergan, Irvine, CA, USA

Image result for Juvéderm Volbella® XC

INDICATION FOR USE: For injection into the lips for lip augmentation and for correction of perioral rhytids in adults over the age of 21.

Consumer Information

RAINDROP® Near Vision Inlay
ReVision Optics, Lake Forest, CA,USA

Image of Raindrop Near Vision Inlay

INDICATION FOR USE: Intrastromal implantation to improve near vision in the non-dominant eye of phakic, presbyopic patients, 41 to 65 years of age, who have manifest refractive spherical equivalent of +1.00 diopters (D) to -0.50 D with less than or equal to 0.75 D of refractive cylinder, who do not require correction for clear distance vision, but who do require near correction of +1.50 D to +2.50 D of reading add.

Consumer Information

OBALON Balloon System
Obalon Therapeutics, Inc., Carlsbad, CA, USA
Picture of the device, indicating the Obalon Balloon System and three balloons in the stomach with radiopaque markers.

Consumer Information



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