[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