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Event Title
December 4-5, 2018: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
December 04-05, 2018

December 4-5, 2018: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 12/04/2018 - 12/05/2018


Date:
December 04-05, 2018
Time:
December 04, 2018

Center Date Time Location
CDRH December 4 - 5, 2018 8:00 a.m. - 6:00 p.m. Hilton Washington DC North/Gaithersburg
Salons A, B, C, and D
620 Perry Pkwy.
Gaithersburg, MD 20877
301–977–8900

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1726]

Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

SUMMARY:  The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee.  The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues.  The meeting will be open to the public.

DATES:  The meeting will be held on December 4 and 5, 2018, from 8 a.m. to 6 p.m.

ADDRESSES:  Hilton Washington DC North/Gaithersburg, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD  20877.  The hotel telephone number is 301-977-8900; additional information available online at:  https://www3.hilton.com/en/hotels/maryland/hilton-washington-dc-north-gaithersburg-GAIGHHF/index.html.  Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:  https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT:  Patricio Garcia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD  20993-0002, patricio.garcia@fda.hhs.gov, 301-796-6875, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area).  A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice.  Therefore, you should always check the Agency’s website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

SUPPLEMENTARY INFORMATION:

Agenda:  On December 4, 2018, the committee will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the OPTIMIZER SMART Implantable Pulse Generator device, sponsored by Impulse Dynamics (USA), Inc.  This first-of-a-kind device is indicated to provide cardiac contractility modulation for class III heart failure patients who are not responding to optimal medical therapy.
On December 5, 2018, the committee will discuss and make recommendations regarding issues relating to the emergence of medical devices, which aim to treat hypertension.  Currently, clinical studies to evaluate the safety and effectiveness of these devices are progressing.  FDA requests panel input regarding the potential indications and labeling for devices intended to treat hypertension and optimal study designs needed to evaluate the potential benefits and risks while considering issues such as medication compliance, patient perspective, and appropriate study controls.

FDA intends to make background material available to the public no later than 2 business days before the meeting.  If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting.  Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.  Scroll down to the appropriate advisory committee meeting link.

Procedure:  FDA will work with affected industry, professional organizations, and societies with an interest in medical devices designed to treat hypertension, as well as members of those groups who wish to make a presentation separate from the general open public hearing; time slots are available on December 5, 2018.  Representatives from industry, professional organizations and societies interested in making formal presentations to the committee should notify the contact person on or before November 13, 2018.

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.  Written submissions may be made to the contact person on or before November 21, 2018.  Oral presentations from the public will be scheduled on December 4 and 5, between approximately 1 p.m. and 2 p.m.  Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 13, 2018.  Time allotted for each presentation may be limited.  If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session.  The contact person will notify interested persons regarding their request to speak by November 14, 2018.

Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities.  If you require accommodations due to a disability, please contact Artair Mallett at artair.mallett@fda.hhs.gov or 301-796-9638 at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings.  Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Dated:  October 24, 2018.

Leslie Kux,

Associate Commissioner for Policy.
 


Event Materials

  • Circulatory System Devices Panel Dec. 4, 2018 Agenda (60.31 KB)
  • Circulatory System Devices Panel Dec. 4, 2018 Roster (82.70 KB)
  • Circulatory System Devices Panel Dec. 4, 2018 FDA Executive Summary
  • Circulatory System Devices Panel Dec. 4, 2018 24 Hour Summary (63.82 KB)
  • Circulatory System Devices Panel Dec. 4, 2018 FDA Presentation
  • Circulatory System Devices Panel Dec. 5, 2018 Agenda (77.92 KB)
  • Circulatory System Devices Panel Dec. 5, 2018 Roster (114.04 KB)
  • Circulatory System Devices Panel Dec. 5, 2018 FDA Executive Summary
  • Circulatory System Devices Panel Dec. 5, 2018 Panel Questions (126.23 KB)
  • Circulatory System Devices Panel Dec. 5, 2018 FDA Presentation (Hypertension) (1,020.99 KB)
  • Circulatory System Devices Panel Dec. 5, 2018 24 Hour Summary (60.07 KB)
  • Circulatory System Devices Panel Dec. 4, 2018 Transcript (954.67 KB)
  • Circulatory System Devices Panel Dec. 5, 2018 Transcript (635.79 KB)
  • Circulatory System Devices Panel Dec. 4-5, 2018 Table of Contents (68.75 KB)
  • Circulatory System Devices Panel Dec. 4-5, 2018 Sponsor Executive Summary
  • Circulatory System Devices Panel Dec. 4-5, 2018 Proposed SSED (Summary of Safety and Effectiveness Data)
  • Circulatory System Devices Panel Dec. 4-5, 2018 Proposed Package Insert - Optimizer SMART IPG Instructions for Use (424.09 KB)
  • Circulatory System Devices Panel Dec. 4-5, 2018 Proposed Package Insert - OMNI II Programmer System and Optimizer Mini Charger Instructions for Use
  • Circulatory System Devices Panel Dec. 4-5, 2018 Proposed Patient Labeling (Optimizer SMART System Patient’s Manual) (234.49 KB)
  • Circulatory System Devices Panel Dec. 4-5, 2018 Proposed Post-Approval Study (221.04 KB)
  • Circulatory System Devices Panel Dec. 4, 2018 Sponsor Presentation
  • Circulatory System Devices Panel Dec. 5, 2018 Presentation (Patient Preferences and Devices for HTN) (448.27 KB)
  • Circulatory System Devices Panel Dec. 5, 2018 Presentation (Patient Preference for Therapies in Hypertension Management)
  • Circulatory System Devices Panel Dec. 5, 2018 Presentation (Device Based Therapies for Hypertension) (314.00 KB)
  • Circulatory System Devices Panel Dec. 5, 2018 Presentation (Current State of Hypertension and Renal Denervation)
  • Circulatory System Devices Panel Dec. 5, 2018 Presentation (Paradise Renal Denervation System )
  • Circulatory System Devices Panel Dec. 5, 2018 Presentation (Clinician and Patient Perspective on Potential of Renal Denervation) (654.56 KB)
  • Circulatory System Devices Panel Dec. 5, 2018 Presentation (The Clinical Risk Associated With Randomizing Participants to a Control Arm in Hypertension Device Trials)
  • Circulatory System Devices Panel Dec. 5, 2018 Presentation (The Limits of Sham-Control in Device Trials of Hypertension) (636.90 KB)
  • Circulatory System Devices Panel Dec. 5, 2018 Presentation - Vascular Dynamics (Clinical Evaluation of Anti-Hypertensive Devices)
  • Circulatory System Devices Panel Dec. 5, 2018 Presentation - Medtronic (Clinical Evaluation of Anti-Hypertensive Devices)

  • FDA Advisory Committee Information Line
    1-800-741-8138
    (301-443-0572 in the Washington DC area)

    Please call the Information Line for up-to-date information on this meeting.

    A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.

    Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Lauren Tesh at (301) 796-9001 at least 7 days in advance of the meeting.

    Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).