[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Notices]
[Pages 7589-7590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3243]


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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.
    Name of Committee: Neurological Devices Panel of the Medical 
Devices Advisory Committee.
    General Function of the Committee: To provide advice and

[[Page 7590]]

recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 23, 2012, from 8 
a.m. to 7 p.m.
    Location: Hilton Washington, DC North/Gaithersburg, Grand Ballroom, 
620 Perry Pkwy., Gaithersburg, MD 20877. The hotel telephone number is 
301-977-8900.
    Contact Person: Avena Russell, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 1535, Silver Spring, MD 20993-0002, 301-796-3805, 
[email protected], or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area), and follow 
the prompts to the desired center or product 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 appropriate 
advisory committee hot line/phone line to learn about possible 
modifications before coming to the meeting.
    Agenda: On March 23, 2012, the committee will discuss current 
knowledge about the safety and effectiveness of the Wingspan Stent 
System with Gateway PTA Balloon Catheter for the treatment of 
intracranial arterial stenosis. 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. The 
Wingspan Stent System with Gateway PTA Balloon Catheter is a 
neurovascular stent, balloon catheter, and delivery system consisting 
of the following components:
    1. Wingspan Stent--This is a self-expanding, nitinol stent with a 
tubular mesh design.
    2. Gateway PTA Balloon Catheter--This balloon catheter is used to 
predilate the lesion prior to introduction of the Wingspan Stent System 
into the patient.
    3. Wingspan Delivery System--This delivery system is a single 
lumen, over-the-wire, coaxial microcatheter that is used to deliver the 
stent to the treatment site within the patient's artery.
    The Wingspan Stent System with Gateway PTA Balloon Catheter has 
been approved under a humanitarian device exemption (HDE) (H050001) for 
the following indications: ``The Wingspan Stent System with Gateway PTA 
Balloon Catheter is indicated for use in improving cerebral artery 
lumen diameter in patients with intracranial atherosclerotic disease, 
refractory to medical therapy, in intracranial vessels with >= 50% 
stenosis that are accessible to the system.''
    Interim results and analyses of data from an ongoing randomized 
clinical trial, ``Stenting and Aggressive Medical Management for 
Preventing Recurrent Stroke in Intracranial Stenosis'' (SAMMPRIS), 
published in the New England Journal of Medicine (2011;365:993-1003), 
will be presented for the Wingspan Stent with Gateway PTA Balloon 
catheter. The committee will be asked to discuss the comparability of 
the patient populations for the approved HDE and SAMMPRIS trial and the 
relevance of the SAMMPRIS trial results to the assessment of safety and 
probable benefit for the Wingspan Stent System with Gateway PTA Balloon 
Catheter HDE.
    FDA recently received a citizen's petition seeking withdrawal of 
the HDE approval and recall of Wingspan stents currently on the market. 
The petitions are available for public review and comment at 
www.regulations.gov under docket number FDA-2011-P-0923.
    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 link.
    Procedure: FDA will work with affected industry and professional 
organizations that have an interest in the Wingspan Stent System and 
who wish to make a presentation separate from the general Open Public 
Hearing; time slots between 2 p.m. and 3 p.m. are provided. 
Representatives from industry and professionals organizations 
interested in making formal presentations to the committee should 
notify the contact person on or before March 1, 2012.
    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 March 9, 
2012. Oral presentations from the public will be scheduled between 
approximately 11 a.m. and 12 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 March 1, 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 March 2, 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 James Clark, 
[email protected] or 301-796-5293 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: February 8, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-3243 Filed 2-10-12; 8:45 am]
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