[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Notices]
[Pages 68788-68789]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-27934]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


Neurological Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public. This meeting is being rescheduled due to the 
postponement of the November 1, 2012, meeting due to unanticipated 
weather conditions caused by hurricane Sandy.
    Name of Committee: Neurological Devices Panel of the Medical 
Devices Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on December 10, 2012, from 
8 a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., 
Grand Ballroom, Gaithersburg, MD 20877. The hotel's telephone number is 
301-977-8900.
    Contact Person: Natasha Facey, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, rm. 1544, Silver Spring, MD 20993-0002, 301-796-5290, 
[email protected] 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 Web site at http://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.
    Agenda: On December 10, 2012, the committee will discuss current 
knowledge about the safety and effectiveness of the CoAxia NeuroFlo 
Catheter device for the intended use of diverting cardiac output to the 
cerebral vasculature via partial occlusion of the descending aorta, 
including in patients with acute ischemic stroke within 14 hours of 
symptom onset.
    The CoAxia NeuroFlo Catheter is a 7F multilumen device with two 
balloons mounted near the distal tip. The proximal end has a multiport 
manifold that provides access for the guidewire, monitoring of blood 
pressure, and independent inflation of the individual balloons. The 
device is placed in the descending aorta. On March 30, 2005, a 
humanitarian device exemption application for the CoAxia NeuroFlo 
Catheter was approved for the following indication for use: The CoAxia 
NeuroFlo Catheter is intended for the treatment of cerebral ischemia 
resulting from symptomatic vasospasm following aneurismal subarachnoid 
hemorrhage, secured by either surgical or endovascular intervention for 
patients who have failed maximal medical management.
    Of note, the CoAxia NeuroFlo Catheter is identical in design to the 
CoAxia FloControl, which is currently cleared for the following general 
indications for use:
    1. The CoAxia FloControl Catheter is intended for use in 
selectively stopping or controlling flow in the peripheral vasculature 
(K023914).
    2. The CoAxia FloControl Catheter is intended for use in 
selectively stopping or controlling flow in the peripheral vasculature, 
which includes the descending aorta (K090970).
    CoAxia has submitted a de novo application for the NeuroFlo for the 
following indication: The CoAxia NeuroFlo Catheter is intended for use 
in diversion of cardiac output via partial occlusion of the descending 
aorta, including patients with acute ischemic stroke within 14 hours of 
symptom onset. The CoAxia NeuroFlo Catheter is also intended for use in 
selectively stopping or controlling blood flow in the peripheral 
vasculature, which includes the descending aorta.
    FDA is convening this committee to seek expert scientific and 
clinical opinion on the risks and benefits of this device based on the 
available premarket and postmarket data. In particular, the committee 
will be asked to discuss the safety and effectiveness data from the 
``Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke'' 
(SENTIS) clinical trial as they relate to the proposed indications for 
use.
    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 Web site 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 Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.

[[Page 68789]]

    Procedure: 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 
December 4, 2012. Oral presentations from the public will be scheduled 
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 26, 2012. 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 28, 2012.
    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 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact AnnMarie Williams, 
Committee Management Staff, 301-796-5966, at least 7 days in advance of 
the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://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: November 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27934 Filed 11-15-12; 8:45 am]
BILLING CODE 4160-01-P