News | Pacemakers | December 31, 2015

FDA Panel Gathering Public Input on Leadless Pacemaker Technology

Micra leadless pacemaker

The Medtronic Micra is an example of some of the new leadless pacemaker technologies in development that are expected to soon be reviewed by the FDA as they move toward U.S. commercialization. 

December 31, 2015 — The U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet in February to discuss and gather public recommendations on clinical trial, post-approval study design and physician training requirements for leadless cardiac pacemaker device technology.  The meeting will take place Thursday, Feb. 18, 2016, from 8 a.m. to 6 p.m. at the Hilton Washington DC North/Gaithersburg, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD,  20877.  The hotel telephone number is 301-977-8900.

The committee will be asked to make recommendations on the acceptability of adverse event rates in acute and chronic timeframes as well as indications for use for this device type, given availability of other technologies with different adverse event profiles; required training and acceptability of observed learning curves for the new device type and necessary elements for post-approval study collection.

FDA intends to make background material available to the public no later than two 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 www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/default.htm.  Scroll down to the appropriate advisory committee meeting 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 Feb.11, 2016.  Oral presentations from the public will be scheduled between approximately 1 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 Feb. 3, 2016.  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 Feb. 4, 2016.

Related Content

A new infection risk scoring system has been developed based on data from the large PADIT Trial.[1] The new scoring system was presented as a follow up to that study during a late-breaking session at Heart Rhythm 2019, the Heart Rhythm Society's 40th Annual Scientific Sessions.

Figure 1: The PADIT infection risk score ranging from 0 to 14 points classified patients into three risk groups, low (0-4), intermediate (5-6) and high (≥7). The risk groups had rates of hospitalization for infection of 0.51%, 1.42% and 3.41%, respectively 

News | EP Lab | May 15, 2019
May 15, 2019 — A new infection risk scoring system has been developed based on data from the large PADIT Trial.[1] Th
Studies Find Race and Gender Disparities in Implantable Heart Devices
News | EP Lab | May 15, 2019
May 15, 2019 - Three new studies show that patients who are medically indicated for implantable heart devices, includ
Heart Rhythm 2019 study shows travelers with common cardiac devices can pass through without restrictions or precautions. HRS 2019, #HRS #HRS19

A new study shows travelers with common cardiac devices can pass through airport body scanners without restrictions or precautions.

News | EP Lab | May 14, 2019
May 14, 2019 – Results from new research show that passengers with cardiac implantable electronic devices (CIEDs), su
News | EP Lab | May 13, 2019
May 13, 2019 – Results from a new survey are the first to report a large discrepancy in patient’s knowledge of their
Concerto CRT-D and Virtuoso ICD implantable cardiac devices are among several Medtronic electrophysiology devices included in a safety alert because of their lack of cybersecurity measures to avoid hacking, according to the FDA.

Concerto CRT-D and Virtuoso ICD implantable cardiac devices are among several Medtronic electrophysiology devices included in a safety alert because of their lack of cybersecurity measures to avoid hacking, according to the FDA.

Feature | EP Lab | March 22, 2019
March 22, 2019 — The U.S.
Medtronic Tyrx Envelope Significantly Reduces Major Infections in Cardiac Implantable Device Patients
News | EP Lab | March 20, 2019
Results from the landmark Worldwide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT) demonstrated...
Videos | EP Lab | February 27, 2019
This is a virtual heart with the same electrophysiology characteristics as the real patient being developed to help o
Seth Worley, M.D., senior consultant, section of cardiac electrophysiology, MedStar Heart and Vascular Institute, developed tools and techniques to optimize transvenous left ventricular (LV) lead implantation, including the I-CRT approach. Here he holds the tools that he personally developed for left ventricular lead implantation to treat heart failure. Photo courtesy of MedStar Heart and Vascular Institute at MedStar Washington Hospital Center.

Seth Worley, M.D., senior consultant, section of cardiac electrophysiology, MedStar Heart and Vascular Institute, developed tools and techniques to optimize transvenous left ventricular (LV) lead implantation, including the I-CRT approach. Here he holds the tools that he personally developed for left ventricular lead implantation to treat heart failure. Photo courtesy of MedStar Heart and Vascular Institute at MedStar Washington Hospital Center.

Feature | EP Lab | January 21, 2019 | Matthew S. McKillop, M.D., FACC, FHRS, and Seth J. Worley, M.D.
Interventional...
An implanted ICD showing its three venous leads. These multiple CRT leads can cause issues when they need to be replaced and are abandoned with new leads put over them in the SVC, which may require lead extraction.

An implanted ICD showing its three leads in the venous system. 

Feature | EP Lab | January 13, 2019 | Dave Fornell, Editor
To extract or abandon broken or infected implantable, venous...
Overlay Init