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U.S. Department of Health and Human Services

Advisory Committees

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July 22-23, 2009: Circulatory System Devices Panel Meeting Announcement

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed 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 July 22 and 23, 2009, from 8 a.m. to 6 p.m.

Location: Hilton Washington DC

North/Gaithersburg, Salons A, B and C,

620 Perry Pkwy., Gaithersburg, MD.


Contact Person: James Swink, Center

for Devices and Radiological Health

(HFZ–450), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 240–276–4050, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code 3014512625. 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 July 22, 2009, the committee will discuss, make

recommendations, and vote on a Humanitarian Device Exemption (HDE)

application, sponsored by Medtronic, Inc., for the MEDTRONIC MELODY

Transcatheter Pulmonary Valve (Model PB10) and MEDTRONIC ENSEMBLE

Transcatheter Valve Delivery System (NU10). The MEDTRONIC MELODY

Transcatheter Pulmonary Valve (Model PB10) and MEDTRONIC ENSEMBLE

Transcatheter Valve Delivery System (NU10) is indicated for use in patients

with the following clinical conditions: Regurgitant (insufficient or leaky)

Right Ventricular Outflow Tract (RVOT)—The right ventricular

outflow tract is that portion of the right ventricle leading up to the

pulmonary valve and pulmonary artery. When the ventricles

contract, blood moves along the outflow tract and through the

pulmonary valve; blood then flows to the lungs where gas exchange

takes place.


Conduits—In the context of this device, a surgically implanted tube

that allows blood to pass from the heart to the pulmonary arteries.

Stenotic (stiff valve leaflets that cannot open or close properly)

RVOT conduits where the risk of worsening regurgitation is a relative

contraindication to balloon dilatation or stenting.


Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16

millimeters (mm) in diameter when riginally implanted.


On July 23, 2009, from 8 a.m. to 10a.m., and from 1 p.m. to 6 p.m., the

committee will discuss general questions about adhesion barriers for

cardiovascular use. Some of these questions will focus on understanding

the target population (pediatric and/or adult) that would benefit from these

devices and the development of appropriate endpoints for a clinical trial.


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. 


Procedure: On July 22, 2009, from 8 a.m. to 6 p.m., and on July 23, 2009,

from 8 a.m. to 10 a.m. and from 1 p.m. to 6 p.m., the meeting is open to the

public. 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 July 15, 2009. Oral presentations from

the public will be scheduled approximately 30 minutes at the

beginning of committee deliberations and approximately 30 minutes near the

end of the deliberations. Those desiring to make 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 r before July 7, 2009. 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 July 8, 2009.

Closed Presentation of Data: On July 23, 2009, from 10 a.m. to 12 noon, the

meeting will be closed to permit discussion and review of trade secret

and confidential commercial information (5 U.S.C. 552b(c)(4)) related

to the design of a potential clinical trial. 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 240–276–8932, 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 (5U.S.C. app. 2).