FDA BRIEF: Week of July 4, 2016

FDA approved

 

ABSORB GT1™ Bioresorbable Vascular Scaffold (BVS) System 

Abbott Vascular in Santa Clara, CA, USA

Image of the device.

INDICATION FOR USE: Temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions (length is less than or equal to 24 millimeters mm) with a reference vessel diameter of greater than or equal to 2.5 mm and less than or equal to 3.75 mm.

UNMET NEED:

  • Coronary heart disease is responsible for about 370,000 deaths/yr
  • Caused by cholesterol-containing deposit build up and narrowing of coronary arteries
  • Treatment by  angioplasty to widen the artery using a metal stent; however, scar tissue formation within the stent can cause restenosis
  • Drug-eluting stents temporarily release a drug to combat restenosis
  • Need for new treatment option for an absorbable device rather than a permanent metallic coronary stent

REG PATHWAY:. PMA. Positive FDA Circulatory Devices Panel voting.

DEVICE DESCRIPTION:

  • Fully absorbable stent mounted on balloon dilatation catheter
  • Made of absorbable polymer, poly(L-lactide) (PLLA), with a thin coating of the absorbable polymer poly(D,L-lactide) (PDLLA) containing the drug everolimus
  • Contains two (2) platinum marker beads, one (1) embedded at each end
  • Absorbable stent is placed into a blood vessel (coronary artery) during angioplasty to help keep the coronary artery open
  • Stent dissolves and will be absorbed by the body in approximately three (3) years, leaving behind only the platinum markers.

EFFECTIVENESS:

  • Single randomized clinical trial (n=1,322), ABSORB vs. XIENCE metallic stent, 5 year followup
  • Endpoint: Combined rate of cardiac death, heart attack at year 1:  7.8%  vs 6.1%
  • Rate of blood clot formatio: 1.5%  vs. 0.7%
  • Importance of vessel sizing to identify arteries that are appropriate for Absorb implantation
  • Overall, clinical outcomes comparable to XIENCE

SAFETY:

  • Adverse events associated with procedure:  Allergic reactions to materials in the device or medications used during the procedure, allergic reaction to the drug everolimus, infection or irritation at the catheter insertion site, internal bleeding, the development of abnormal connections between arteries and veins, embolism, or other coronary artery complications that may require medical intervention and that could lead to death.

LABEL: Not yet posted


 

DIFFERIN Gel 0.1% (adapalene),  topical gel

Galderma Laboratories, L.P., Fort Worth, TX, USA

INDICATION : For the over-the-counter (OTC) treatment of acne, for use in people 12 years of age and older.

UNMET NEED:

  • Millions of  adolescents to adults suffer from acne
  • Need for access to a new safe and effective OTC option

REG PATHWAY:

  • Originally approved in 1996 as prescription product for acne vulgaris treatment in patients 12 years of age
  • Now approved to be made available OTC

EFFICACY & SAFETY:

  • Safety and efficacy initially established based on 5 clinical trials
  • Post-marketing safety data  accrued from 1996-2016
  • Consumer studies (label comprehension study, self-selection study, actual use trial) – Can appropriately select and use product
  • Maximal use trial – Drug absorption through acne-affected skin when applied daily over a large surface area (face, shoulders, upper back and chest) : Limited absorption

LABEL: Not posted


SUREPATH Preservative Fluid  with COBAS HPV Test 

SurePath Preservative Fluid, Becton Dickinson and Company, Franklin Lakes, NJ, USA

Cobas HPV Test, Roche Molecular Systems, Basel, SWITZERLAND

hpv-for-surepath-large.png

 

INDICATION FOR USE: Use with cervical cell samples obtained for a Pap test to screen women age 30 and older for Human Papilloma Virus (HPV) in order to determine whether additional follow-up and diagnostic procedures are needed. Roche cobas HPV Test with SurePath indicated in women age 21 and older who have already had an abnormal Pap test result (borderline cellular cytology) in order to determine whether additional follow-up and diagnostic procedures are needed. The test with SurePath is also able to detect high-risk HPV genotypes 16 and 18 in the same populations of women.

UNMET NEED:

  • HPV infections are the most common sexually-transmitted infections
  •  HPV genotypes 16 and 18 cause approximately 70% cervical cancers worldwide
  • 12,990 new cases and 4,120 deaths in US in 2016
  • Need for  HPV test to be used with cervical cells obtained for a Pap test and collected in SurePath Preservative Fluid
  • Need for specific instructions for laboratories to process cervical samples collected in SurePath Preservative Fluid to minimize the risk of false negative results.

REG PATHWAY:

  • Cobas HPV Test, when used with samples collected into SurePath Preservative Fluid, demonstrated to be safe and effective for cervical cancer screening
  • Comparable performance to specimens collected into ThinPrep PreservCyt Solution, another type of cell collection media
  • FDA approval includes triage of ASC-US (Atypical Squamous Cells of Undetermined Significance) Pap cytology results and adjunct testing with Pap cytology for women 30 years of age and older

LABEL: Not posted


 

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