[Federal Register Volume 76, Number 199 (Friday, October 14, 2011)]
[Notices]
[Pages 63928-63929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-26558]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


Circulatory System 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: Circulatory System 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 7 and 8, 2011, 
from 8 a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C, 
and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone 
number is 301-977-8900.
    Contact Person: James Swink, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002, [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 December 7, 2011, the committee will discuss, make 
recommendations, and vote on information related to a supplement to the 
premarket approval application (PMA) P010031, sponsored by Medtronic, 
Inc. Medtronic is requesting FDA approval to expand the indications for 
use for all commercially available Medtronic Cardiac Resynchronization 
Therapy Defibrillator (CRT-D) devices covered under PMA P010031. The 
company has proposed the following expanded indication statement based 
on the results of the REVERSE and RAFT clinical studies: ``Medtronic 
cardiac resynchronization therapy defibrillator (CRT-D) systems are 
indicated for heart failure patients who meet the following 
classification: NYHA Functional Class II who remain symptomatic despite 
stable, optimal medical therapy, and who have left bundle branch block 
(LBBB) with a QRS duration >=120 ms, and left ventricular ejection 
fraction <=30%.''
    On December 8, 2011, the committee will discuss, make 
recommendations, and vote on information related to the PMA for the 
CardioMEMS HF Pressure Measurement System (HF System) sponsored by 
CardioMEMS, Inc. The CardioMEMS HF System is a permanently implantable 
pressure measurement system designed to provide daily pulmonary 
arterial pressure measurements including systolic, diastolic, and mean 
pulmonary artery pressure. These measurements are used to guide 
treatment of congestive heart failure. The system consists of the 
following:
     Implantable Sensor--The Pressure Sensor is 15 millimeters 
(mm) in length, 3.41 mm in width and is 2 mm thick, consisting of a 
three dimensional coil and pressure sensitive capacitor encased between 
two wafers of fused silica. The coil (inductor) electromagnetically 
couples to the Sensor and allows the remote measurement of the resonant 
frequency of the LC circuit. This allows for wireless communication 
with the Sensor and eliminates the need for an onboard source of 
energy, such as a battery.
     Delivery System--The Delivery System allows the placement 
of the Pressure Sensor within the distal pulmonary artery. There are 
two versions of the Delivery System. The first includes a hydrophilic 
coating on the distal portion of the catheter shaft and the second has 
no coating on the catheter shaft. Both delivery catheters have a usable 
length of 120 centimeters and are compatible with a 0.018'' guidewire. 
The Delivery System (with HF Sensor) is introduced over a guidewire 
through an 11Fr sheath. Tether wires connect the Sensor to the Delivery 
System until the physician determines that the Sensor is properly 
positioned within the distal pulmonary artery. Once the Sensor is in 
position, the tether wires are withdrawn, releasing the Sensor.
     Electronics Unit (Interrogator) and database--The 
Electronics Unit contains hardware and software to acquire and process 
signals from the sensor, provides a user-friendly system interface for 
both patients and clinicians, and transfers PA measurements to a secure 
database for review by medical professionals. The database is a Web-
based server that contains software, which receives data transmitted 
from the electronics unit, and presents the data for review by medical 
professionals.
    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.

[[Page 63929]]

    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 
November 30, 2011. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. on December 7 and 8, 2011. 
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 22, 2011. 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 23, 
2011.
    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 at 
[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: October 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-26558 Filed 10-13-11; 8:45 am]
BILLING CODE 4160-01-P