July 2015 – Drug and Device Digest

FDA News, Week of July 20, 2015

Improving Access to Medical Devices: FDA Uses Existing Clinical Data to Reduce Premarket Data Needs

Ben Fisher, Ph.D., Director, Division of Reproductive, Gastro-Renal, and Urological Devices, ODE, CDRH.

Utilizing publicly available clinical data to design less burdensome clinical design for new medical devices to reduce cost and time for device clinical development.  Criteria:

More Collaboration, Research Needed to Develop Cures,

Robert Califf, M.D., Deputy Commissioner for Medical Products and Tobacco.

Focus on targeted drug development so that drug discovery and development is in pace with unmet needs for many diseases.

Improve the efficiency and predictability of clinical drug development using advanced scientific tools such as:

  • genomic data, biomarkers and surrogate endpoints
  • modernized clinical trial designs, disease modeling and clinical trial simulation (bioinformatics)
  • advanced imaging technology

Focus on four key disease areas other than cancer and HIV/AIDS.

  • Alzheimers
  • Diabetes
  • Rare disease (<20,000 patients)
  • Hepatitis C


Storyline : CDER and CDRH recent blogs draw attention to FDA’s focus on innovation.  In keeping with the spirit of the 21st Century Cures Act, Senior CDER and CDRH members are highlighting approaches to drug/device development that could enable quicker access to new therapies and devices that have been demonstrated to be safe and effective.

FDA approved

Theranos secures FDA CLIA waiver for the Herpes simplex 1 virus Lab Test (Theranos, Palo Alto, CA)

theranosTest system for the herpes simplex 1 virus IgG (HSV-1), which was cleared by the FDA earlier this month, received a Clinical Laboratory Improvement Amendments (CLIA) Waiver from FDA, permitting its use in locations outside of traditional clinical laboratories. The decision is based on submission of comprehensive data, beyond the extend required by the FDA, to demonstrate the reliability and accuracy of test outside certified laboratories. Data demonstrated that conditions expected in non-laboratory testing would not affect the integrity of results – temperature fluctuations, humidity, tilting, power fluctuations, contamination, and storage and shipping conditions, among other variables in samples and conditions

Storyline : The approval of the kit and its subsequent CLIA waiver is in line with Theranos’ mission is to make actionable information accessible to everyone at the time it matters most. The company is also active in interacting with FDA on developing framework for regulation of Laboratory Developed tests (LDTs) https://www.theranos.com/content/pdf/theranos_comment_ldt_guidance.pdf

Edwards SAPIEN 3™ Transcatheter Heart Valve (Edwards Lifesciences LLC, Irvine, CA )


Regulatory Pathway : PMA, Priority Review ( availability of the device is in the best interest of the patients). No Advisory Committee Meeting.

Indications for Use : Relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy


  • PARTNER II trial, single arm, non-randomized, historical-controlled study to compare the third generation Edwards SAPIEN 3 THV system with the first generation Edwards SAPIEN THV system in patients who either have high risk for surgery or cannot undergo surgery
  • Supplemental : Study S3OUS conducted in Europe and Canada to support the CE Mark.
  • Primary Endpoint : Composite of all cause death, stroke, and aortic insufficiency (AI) ≥ moderate at 30 days : 6.7% (SAPIEN 3) vs . 15.6% (SAPIEN) meeting pre-specified non-inferiority criteria in PARTNER II. Supported by ex-US study outcomes.
  • Supportive secondary endpoints were improvement in AI, Major Vascular Complications, improvement in valve performance, 6 min walk test, Length of Stay in ICU, NYHA classification, QoL measures

Safety : Procedure related complications such as death, stroke, myocardial infarction, major vascular complications, bleeding, conduction disturbance, and acute kidney injury.

Benefit/Risk : probable benefits (improved valve hemodynamic performance, functional status, QoL) outweigh procedure related risks in patients with severe native aortic stenosis who are at high or greater risk for open aortic valve replacement surgery.

activL® Artificial Disc (Aesculap Implant Systems, LLC, Center Valley, PA)

artificial disk

Intended Use: Reconstruction of the disc at one level (L4-L5 or L5-S1) following single-level discectomy in skeletally mature patients with symptomatic degenerative disc disease (DDD) with no more than Grade I spondylolisthesis at the involved level.

Reg pathway : PMA. No Advisory Committee.


  • Randomized (2:1), single masked, concurrently controlled, non-inferiority clinical trial to compare the safety and effectiveness of the activL to one of two alternative lumbar total disc replacement control devices (DePuy Spine Charité (Charité) or DePuy Synthes Spine ProDisc-L (ProDisc-L)).
  • Post-operative success (improvement in pain and disability) at 24 mo composed of Oswestry Disability Index (ODI), neurological status, radiographic range of motion status, device status, and no serious device related adverse events. Noninferiority demonstrated.

Safety: Adverse event rates, neurologic status, and the need for subsequent surgery at the index level similar to comparative devices.


Drug Approvals:

  • Praluent (alirocumab) injection : For use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol.
  • Odomzo (sonidegib) :  To treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy.
  • Technivie (ombitasvir, paritaprevir and ritonavir) : For use in combination with ribavirin for the treatment of hepatitis C virus (HCV) genotype 4 infections in patients without scarring and poor liver function (cirrhosis).

Reviews to be posted next week

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