[Federal Register Volume 78, Number 174 (Monday, September 9, 2013)]
[Notices]
[Pages 55081-55082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21827]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


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 October 8 and 9, 2013, 
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: Jamie Waterhouse, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Silver Spring, MD 20993, 301-796-3063, 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

[[Page 55082]]

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 both days the committee will discuss, make 
recommendations, and vote on devices indicated for use in patients with 
heart failure (HF). On October 8, 2013, the committee will discuss, 
make recommendations, and vote on information related to the premarket 
approval application regarding the expansion of indications supported 
by the BLOCK HF trial to apply to all market-approved Medtronic Cardiac 
Resynchronization Therapy-Pacemaker (CRT-P) and Cardiac 
Resynchronization Therapy-Defibrillator (CRT-D) devices. The devices 
are pulse generators either without (CRT-P) or with (CRT-D) 
defibrillation capabilities. The devices require the implantation of at 
least a right ventricular (RV) and a left ventricular (LV) lead for 
sensing and pacing functionality. The RV lead used with a CRT-D device 
also has the capability to deliver high voltage energy. The 
implantation of a right atrial (RA) lead is left to the discretion of 
the clinician for both devices.
    The requested expansion in indications for use was studied under 
the BLOCK HF trial. The trial was a prospective, multisite, randomized, 
double-blinded, parallel-controlled investigational device exemption 
(IDE) study. The primary objective of the trial was to demonstrate that 
the time until the first event of all-cause mortality, heart-failure-
related urgent care, or a significant increase in left ventricular end 
systolic volume index (LVESVI) for subjects programmed to biventricular 
pacing is superior to that of subjects programmed to right ventricular 
pacing.
    On October 9, 2013, the committee will discuss, make 
recommendations, and vote on information related to the premarket 
approval application for CardioMEMS, Inc. ChampionTM HF 
Monitoring System. 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 arterial (PA) pressure. These measurements are used 
to guide treatment of congestive heart failure. The system consists of 
the following:
    Implantable Sensor--The Pressure Sensor consists 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 inductive/capacitive (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 are 
compatible with a guidewire. The Delivery System (with HF Sensor) is 
introduced over a guidewire through a 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 system interface for both patients and clinicians, 
and transfers PA measurements to a 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 meeting 
link.
    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 
September 24, 2013. On October 8 and 9, 2013, 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 
September 16, 2013. 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 September 18, 
2013.
    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, 
Conference Management Staff, at [email protected] or 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: September 4, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-21827 Filed 9-6-13; 8:45 am]
BILLING CODE 4160-01-P