Authorizations: MAGTRACE/SENTIMAG Magnetic Localization System, SURPASS Flow Diverter, MOLECULIGHT i:X, POTELIGEO injection – Drug and Device Digest


Magtrace and Sentimag Magnetic Localization System

 Endomagnetics Inc.

INDICATION FOR USE: To assist in localizing lymph nodes draining a tumor
site, as part of a sentinel lymph node biopsy procedure, in patients with breast cancer undergoing a mastectomy. Magtrace™ is intended and calibrated for use ONLY with the Sentimag® system.


  • Sentinel lymph node biopsies are crucial for determining whether a patient’s breast cancer has spread and helping the provider determine the most appropriate course of treatment
  • System offers patients undergoing mastectomy an option for their sentinel lymph biopsy procedure that does not require the injection of radioactive materials


  • Sensitive magnetic sensing probe and base unit designed to detect small amounts of Magtrace, the magnetic tracer drug that is injected into breast tissue
  • Magtrace particles travel to lymph nodes, become physically trapped in them, facilitating magnetic detection of the lymph nodes
  • Following injection of Magtrace, the Sentimag probe is applied to the patients’ skin in areas closest to the tumor site containing the lymph nodes
  • Sensing of the magnetic particles is indicated by changes in audio and visual alerts from the base unit, enabling the surgeon to move the hand-held probe around the area of the lymph nodes, and locate the sentinel lymph node or nodes (if there are more than one)
  • Surgeon makes a small incision and removes the node, which is checked by a pathologist for the presence of cancer cell
  • Negative result: Suggests cancer has not spread to nearby lymph nodes
  • Positive result: May indicate cancer present in sentinel lymph node,  nearby lymph nodes and, possibly, other organs
  • Help determine stage of cancer and develop appropriate treatment plan


  • Trial of 147 patients with breast cancer, n=147, Sentimag System vs. control methodin sentinel lymph node detection ratw
  •  94.3% for Sentimag System vs. 93.5% for control
  • Overall, 98.0% same detection rate with both Sentimag System and control
  • Most common adverse event: Breast discoloration, cardiac disorder (bradycardia) and potential allergic reaction to the magnetic materials
  • Contraindication: Hypersensitivity to iron oxide or dextran compounds

REGULATORY PATHWAY: PMA, Combination Product

  • Product Code: PUV
  • Classification: III
  • Classification Name:  Lymph Node Location System during Sentinel Biopsy Procedure
  • Coordinated, cross-agency approach- Clinical review conducted by CDRH in consultation with CDER and with support from Oncology Center of Excellence. All other aspects of review and final product approval by CDRH


LABEL Part 2


Surpass Streamline Flow Diverter


INDICATION FOR USE: In the endovascular treatment of patients (18 years of age and older) with unruptured large or giant saccular wide-neck (neck width ≥ 4 mm or dome-to-neck ratio < 2) or fusiform intracranial aneurysms in the internal carotid artery from the petrous segment to the terminus arising from a parent vessel with a diameter ≥ 2.5 mm and ≤ 5.3 mm.


  • Self-expandable braided device preloaded into a delivery system. Each device is shipped sterile and labeled for single use only
  • Consists of the following major components: Surpass Flow Diverter (Implant),  Delivery Catheter, Pusher


  • Multi-center, prospective, non-randomized clinical study., n=180, follow-up at discharge, 30 days, 6 months, and 12-months post-procedure
  • Primary Safety endpoint: % experiencing neurologic death or major ipsilateral stroke through 12-months post-procedure
  • Major Effectiveness endpoint: % with complete (100%) occlusion (Raymond-Roy Class I) of the treated intracranial aneurysm without clinically significant stenosis
  •  62.8% achieved complete occlusion of their intracranial aneurysm within 1year post-procedure without re-treatment or clinically significant in-stent stenosis


  • Product Code: OUT
  • Classification: III
  • Generic Name: Intracranial Aneurysm Flow Diverter



MolecuLight i:X

MolecuLight Inc.

INDICATION FOR USE:  Handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to:

  1. view and digitally record images of a wound, and
  2. view and digitally record images of fluorescence emitted from a wound when exposed to an excitation light

For prescription use only.

GENERIC DEVICE TYPE: Wound autofluorescence imaging device

Tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information


  • Classification: I
  • Product Code: QCR
  • Regulation Number: 21 CFR 878.4165
  • Regulation Name: Wound autofluorescence imaging device

IDENTIFIED RISKS: Electrical/mechanical/thermal, electromagnetic compatibility (EMC) and optical safety of the device, and the error in fluorescence detection from the wound.

  • No special controls



POTELIGEO (mogamulizumab-kpkc) injection 

Kyowa Hakko Kirin

INDICATION FOR USE: Treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy


  • Mycosis fungoides and Sézary syndrome are rare, hard-to-treat types of non-Hodgkin lymphoma
  • Fills an unmet medical need for these patients

MECHANISM OF ACTION: CC chemokine receptor type 4 (CCR4)-directed monoclonal antibody; CCR4 present in some cancern cells


  • Clinical trial, n=372 patients with relapsed MF or SS, Poteligeo vs. vorinostat
  • Progression-free survival:  Median 7.6 months vs. median 3.1 months


  • Most common side effects: Rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain and upper respiratory tract infection
  • Serious warnings:  Risk of dermatologic toxicity, infusion reactions, infections, autoimmune problems,  complications of stem cell transplantation that uses donor stem cells (allogeneic) after treatment with the drug


  • Priority Review and Breakthrough Therapy designation, Orphan Drug designation
  • Postmarketing Requirements: Characterize complications after allogeneic hematopoietic stem cell transplantation
  • Exempt from pediatric assessments


Image credit: Endomagnetics, Stryker, MolecuLight Inc., Kyowa Hakko Kirin

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