FDA Approvals, Classifications: SAPIEN 3, SENTINEL System, GLEOLAN, TRUVADA generic – Drug and Device Digest

Week of June 5, 2017

FDA approved

EXPANDED INDICATION FOR USE: Indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the STS risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

 REG PATHWAY: PMA supplement

  • Priority Review status because device availability is in the best interest of patients
  • Device Generic Name: Aortic or mitral valve, prosthesis, percutaneously
  • Device Procode: NPT, NPU
  • Original PMA approved in 2015
  • Current supplement to expand to include patients with failed bioprosthetic heart valve in the aortic or mitral position


  • Analysis of real-world off-label use data captured in Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry (n=314)
  • Valve Performance:  Clinically significant improvements;  mean aortic valve pressure gradient decreased from 39.3 ± 15.8 mmHg to 21.5 ± 11.3 mmHg at 30 d
  • NYHA: 85.4% of the patients had an improved NYHA class at the 30-day visi
  • Quality of Life (QoL) – KCCQ clinical summary score: Improved from 39.4 at baseline to 75.3 at 30 d


  • Did not include specific information
  • Patients/physicians likely to prefer due to less invasive approach (FDA belief)
  • High off-label use supports this belief


  • All-cause death: 4.5% and 6.8% at 30 days in aortic and mitral valve-in-valve patients, respectively
  • Aortic valve-in-valve patients: Stroke and reintervention – 1.0%, 0.3 %
  • Mitral valve-in-valve patients: Stroke, heart failure-related readmission – 0.7%,  0.8%, 0.4%



SENTINEL Cerebral Protection System

Claret Medical

INDICATION FOR USE:  For use as an embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures. The diameters of the arteries at the site of filter placement should be between 9 – 15 mm for the brachiocephalic and 6.5 – 10 mm in the left common carotid.

REG PATHWAY: De Novo request

  • Regulation Number: 21 CFR 870.1251
  • Regulation Name: Temporary catheter for embolic protection during transcatheter  intracardiac procedures
  • Regulatory Classification: Class II
  • Product Code: PUM

GENERIC DEVICE TYPE:  Temporary catheter for embolic protection during transcatheter intracardiac procedures

  • Single use percutaneous catheter system that has (a) blood filter(s) at the distal end. This device is indicated for use while performing transcatheter intracardiac procedures. The device is used to filter blood in a manner that may prevent embolic material (thrombus/debris) from the transcatheter intracardiac procedure from  traveling towards the cerebral circulation.


  • Device failure leading to debris embolization and stroke or death: Non-clinical Performance Testing, Animal Testing, Clinical Performance Testing
  • Impeded or disrupted blood flow leading to peripheral ischemia: Non-clinical Performance Testing, Animal Testing, Clinical Performance Testing, Labeling
  • Device incompatibility with transcatheter intracardiac procedure device leading to prolonged treatment time or device failure: Non-clinical Performance Testing, Animal Testing, Clinical Performance Testing, Labeling
  • Adverse tissue reaction:  Biocompatibility Evaluation
  • Vascular Injury due to device delivery, deployment, placement, or retrieval:  Non-clinical Performance Testing, Animal Testing, Clinical Performance Testing, Labeling



GLEOLAN (aminolevulinic acid hydrochloride, ALA HCl)

NX Development Corp.

INDICATION:  In patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery


  • Orphan designation, Priority Review

MECHANISM OF ACTION:  ALA occurs endogenously as a metabolite; accumulation of ALA metabolite PpIX in tumor cells. Gleolan used with an operating microscope adapted with a blue emitting light source allows tumor tissue to be visualized as red fluorescence. Tissue lacking sufficient PpIX concentrations appears blue


  • 3 clinical studies (n=527), patients with preoperative MRI compatible with high-grade glioma (WHO Grade III or IV) undergoing surgical resection
  • Presence of fluorescence (positive/negative) was compared to tumor status (true/false) using histopathology as reference standard
  • High predictive value for visualization of malignant tissue


  • Phototoxic reactions, hypersensitivity reactions, and interpretation errors (false negatives and false positives)
  • Increase in extent of resection might increase risk of serious neurologic deficits
  • Adverse reactions: Pyrexia, hypotension, nausea, and vomiting


Image result for truvada logoTRUVADA (Emtricitabine and tenofovir disoproxil fumarate) generic

Teva Pharmaceuticals

INDICATION: For the treatment of HIV-1, in combination with other antiretroviral agents, and for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to prevent sexually-acquired HIV infection in adults at high risk

REG PATHWAY: ANDA, Therapeutic Equivalence Code- AB

SAFETY: Diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash



Image credits: FDA, Claret Medical, NX Corp, Gilead

Scroll to Top