|CDRH||December 7-8, 2011||8:00 a.m. - 6:00 p.m.||Hilton Washington DC North/Gaithersburg|
Salons A, B, C, and D
620 Perry Pkwy.
Gaithersburg, MD 20877
On December 7, 2011, the committee will discuss, make recommendations, and vote on information related to a supplement tothe 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/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/default.htm. Scroll down to the appropriate advisory committee link.
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.
James Swink, Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993–0002
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.
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 James.Clark@fda.hhs.gov 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).