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SJM Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff

St. Jude’s Medical (Abbott)

INDICATION FOR USE: Use as a replacement valve in newborn pediatric patients with a diseased, damaged, or malfunctioning mitral or aortic heart valve

ADDRESSING UNMET NEED:

  • Smallest mechanical valve size approved in the world
  • > 35,000 babies in U.S. born with congenital heart defects, requiring heart valve surgery, replacement heart valve surgery
  • Limited replacement heart valve options because of patients’ small size
  • Masters Series 15-mm HP valve represents important treatment option

DESCRIPTION:

  • Rotatable, bileaflet (two-leaflet) valve designed for implantation in the aortic or mitral position
  • Bileaflet design consists of two semi-circular discs
  • Open and close in response to blood pressure changes during the heartbeat
  • Similar to a patient’s own valve

EFFECTIVENESS AND SAFETY:

  • Single-arm study (N=20) Age 1.5 weeks to 27 months, serious heart failure
  • Probability of survival post-implant:  69.3%
  • Probability of not experiencing a valve-related adverse event: 66.8%
  • Adverse events in 1 year followup: Blood clots in the device, bleeding in the brain
  • Anticoagulation therapy may be necessary after procedure, to prevent clotting on the device

REGULATORY PATHWAY:

  • PMA initially approved in 1995 for use in adult patients
  • Also approved for use in replacing previously implanted aortic or mitral prosthetic heart valves
  • New approval expands range of valve sizes available

REIMBURSEMENT:

  • Considerations: Hospital Coding And Reimbursement (ICD-9, ICD-10), Inpatient Reimbursement (MS-DRG), Hospital Billing (FDA approved indication, diagnosis, condition, procedure)
  • Sponsor Coding information

Fact Sheet

SAFETY INFORMATION


Capture.JPG23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 

23andMe

INDICATION FOR USE: 

Personal Genome Service (PGS) uses qualitative genotyping to detect select cxlinically relevant variants in genomic DNA isolated from human saliva collected from individuals ≥18 years with the Oragene Dx model OGD500.001 for the purpose of reporting and interpreting genetic health risks, including 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants).

The 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) is indicated for reporting of the 185delAG and 5382insC variants in the BRCA1 gene and 6174delT variant in the BRCA2 gene.

The report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at  increased risk of developing prostate cancer. The three variants included in this report are most common in people of Ashkenazi Jewish descent and do not represent majority of BRCA1/BRCA2 variants in the general population.

The test report does not describe a person’s overall risk of developing any type of cancer, and the absence of a variant tested does not rule out the presence of other variants that may be cancer-related. This test is not a substitute for visits to a healthcare provider for recommended screenings or appropriate follow-up and should not be used to determine
any treatments.

ADDRESSING UNMET NEED: 

  • Provides information on increased breast, ovarian or prostate cancer risk to those who might not otherwise get genetic screening
  • Step forward in the availability of Direct-To-Consumer genetic tests

GENERIC DEVICE TYPE:  Cancer Predisposition Risk Assessment System for BRCA1/BRCA2 Select Variants

Qualitative in vitro molecular diagnostic system used for detecting variants in genomic deoxyribonucleic acid (DNA) isolated from human specimens that will allow users to access information about their genetic predisposition for some cancers.

The test could help to inform conversations with a healthcare professional. Assessment system is for over-the-counter use.

TEST ACCURACY AND REPRODUCIBILITY: 

  • Sufficient data to show that the test is accurate (i.e., can correctly identify the three genetic variants in saliva samples), and can provide reproducible results
  • Accuracy> 99% concordance to Sanger sequencing
  • Precision> 99% reproducibility and repeatability
  • User comprehension studies, using representative GHR test reports
  • Instructions, reports easy to follow and understood by consumer
  • Test report provides information describing what results mean, interpret results and additional information

RISKS AND MITIGATIONS:

  • Incorrect understanding of the device and test system: General controls and special controls 
  • Incorrect test results (false positives, false negatives): General controls and special controls 
  • Incorrect interpretation of test results: General controls and special controls 

REGULATORY PATHWAY: De Novo Request

  • Regulation Number: 21 CFR 866.6090
  • Regulation Name: Cancer Predisposition Risk Assessment System for BRCA1/BRCA2 Select Variants
  • Regulatory Class: Class II
  • Product Code: QAZ

REIMBURSMENT:

  • N/A. Non-prescription product

ORDER


CaptureTROGARZO™ (ibalizumab-uiyk) injection

TaiMed Biologics USA Corp.

INDICATION:  In combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.

ADDRESSING UNMET NEED: 

  • Multidrug resistant HIV patients have limited treatment options
  • High risk of HIV-related complications and progression to death
  • First drug in new class of antiretroviral medications to provide significant benefit to patients who have run out of treatment options; improve outcomes

DESCRIPTION: Recombinant humanized monoclonal antibody, blocks HIV-1 from infecting CD4+ T cells by binding to domain 2 of CD4 and interfering with post-attachment steps required for entry

EFFICACY:

  • Single arm, multicenter clinical trial, n=40 heavily treatment-experienced
    HIV-infected subjects with multidrug resistant HIV-1,  viral load >1,000 copies/mL
  • 3 discreet periods: Control, functional monotherapy period, maintenance period
  • Primary efficacy endpoint: Proportion of subjects achieving a ≥ 0.5 log10 decrease in viral load in functional monotherapy period vs control period
  • 83% (monotherapy period) vs. 3% (control period)
  • 55% had a ≥ 1 log10 reduction in viral load, 48% had a ≥ 2 log10 reduction
  • 43% achieved HIV RNA suppression

SAFETY:

  • Seriousness of disease, need to individualize other drugs in treatment regimen, and safety data from other trials considered in evaluating Trogarzo development program
  • 292 patients with HIV-1 infection exposed to Trogarzo IV infusion
  • Most common adverse reactions: Diarrhea, dizziness, nausea and rash. Severe side effects included rash and changes in the immune system (immune reconstitution syndrome)

REGULATORY PATHWAY: BLA

  • Fast Track, Priority Review and Breakthrough Therapy designations
  • Also received Orphan Drug
  • Several postmarketing requirements

REIMBURSEMENT

LABEL


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Imugen Babesia microtiArrayed Fluorescent Immunoassay (AFIA)

Oxford Immunotec

INTENDED USE:

Donor screening test to detect antibodies to Babesia microti in plasma samples from individual human donors, including volunteer donors of whole blood and blood components, as well as other living donors.

Also intended for use to screen organ and tissue donors when specimens are obtained while the donor’s heart is still beating

ADDRESSING UNMET NEED: 

  • Babesiosis caused by Babesia parasites transmitted by Ixodes scapularis ticks (blacklegged or deer ticks)
  • 1,000 -2,000 cases reported each year
  • Babesia can also be transmitted by transfusion of blood
  • First approval of Babesia detection tests for use in screening donors

REGULATORY PATHWAY: BLA

  • Priority review
  • Currently is no FDA guidance for the testing of donor samples for Babesia; planning to issue guidance

CBER Infectious disease tests


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SkinPen Precision System

Bellus Medical, LLC

INDICATION FOR USE:  Microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years or older

GENERIC DEVICE TYPE: Microneedling device for aesthetic use

Device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use. This classification does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs, or biologics.

RISKS AND MITIGATIONS:

  • Adverse tissue reaction: Biocompatibility evaluation, Labeling
  • Cross-contamination and infection: Sterilization validation, Reprocessing validation, Non-clinical performance testing, Shelf life testing, Labeling
  • Electrical shock or electromagnetic interference with other devices:  Electromagnetic compatibility testing, Electrical safety testing, Labeling
  • Damage to underlying tissue including nerves and blood vessels, scarring, and
    hyper/hypopigmentation due to (i) Exceeding safe penetration depth (ii) Mechanical failure (iii) Software malfunction: Non-clinical performance testing, Technological characteristics, Shelf life testing, Labeling, Software verification, validation, and hazard analysis

REGULATORY PATHWAY: De Novo

  • Regulation Number: 21 CFR 878.4430
  • Regulation Name: Microneedling device for aesthetic use
  • Regulatory Class: Class II
  • Product Code: QAI

REIMBURSEMENT:

  • CMS does not cover products for aesthetic use; not deemed to be medically necessary

ORDER


Image Credits: Abbott, 23andMe, Taimed, Oxford Immunotec, Bellus Medical

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