Feature | November 08, 2012

FDA Develops Regulations for Intra-aortic Balloon Pumps 40 Years After Their Introduction

Panel will also discuss other cardiovascular technologies grandfathered after tightened restrictions implemented in 1979

FDA Intra-Aortic Balloon Pumps

November 8, 2012 — A U.S. Food and Drug Administration (FDA) advisory committee is meeting Dec. 5 to discuss how to classify and regulate intra-aortic balloon pumps (IABPs), which have been grandfathered without clear policy since the FDA tightened regulations on medical devices in the late 1970s. The panel will also discuss classifications for two other grandfathered technologies, including external counter-pulsating (ECP) devices and cardiopulmonary bypass blood pumps.

The meeting will be held Dec. 5 and 6 from 8 a.m. to 6 p.m. at the Holiday Inn, Gaithersburg, Md.

On Dec. 5, the Circulatory System Devices Panel of the Medical Devices Advisory Committee will discuss making recommendations regarding regulatory classification of IABPs to either reconfirm to class III (subject to premarket approval application [PMA]) or reclassify to class I or class II (subject to premarket notification [510(k)]). IABPs and their control systems are one of the remaining pre-amendment class III devices.

In 1979, the FDA published a proposed rule for classification of IABP devices as class III requiring PMA. The panel recommended class III because the device is life supporting and because the panel believed that insufficient medical and scientific information existed to establish a standard to assure the safety and effectiveness of the device. The panel also stated that controversy exists as to whether the device is beneficial in the many situations in which it is used, and that it is difficult to use the device safely and effectively.

Subsequent to the proposed rule, in 1980, the FDA classified IABP devices into class III after receiving no comments on the proposed rule. In 1987, FDA published a clarification by inserting language in the codified language, stating that no effective date had been established for the requirement for premarket approval for IABP devices.

On Dec. 5, the committee will also discuss external counter-pulsating (ECP) devices. These systems typically consist of a treatment table, pressure cuffs and a controller. They are intended to provide noninvasive circulatory support by applying external pressure to the lower extremities during diastole to increase coronary perfusion pressure, and releasing external pressure during systole to reduce left ventricular workload.  

On Dec. 6, the committee will discuss nonroller-type cardiopulmonary bypass blood pumps, another remaining pre-amendment class III device. These devices use a method other than revolving rollers to pump blood. The FDA has reviewed two types: Centrifugal type pumps utilize a rotor to impart energy to the blood in an extracorporeal circuit through centrifugal forces. These pumps are part of an extracorporeal circuit usually containing an oxygenator and are intended to provide cardiopulmonary support, during procedures such as cardiopulmonary bypass surgery, for periods lasting six hours or less. Micro-axial type pumps are comprised of a pump motor, a cannula and a catheter that connects to a console. These pumps are not designed to be used with an oxygenator but are temporarily placed within the heart or vasculature to provide cardiac support only.    

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 website 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 website after the meeting.

For more information: www.fda.gov/AdvisoryCommittees/default.htm

Related Content

aortic valve reconstruction, surgery, PinnacleHealth, Pennsylvania
News | Cardiovascular Surgery| May 04, 2016
Three PinnacleHealth patients recently underwent a new procedure for aortic valve reconstruction using the patients'...
FDA, CDRH, national evaluation system, medical device development
Feature | Business| May 04, 2016
The U.S. Food and Drug Administration (FDA) announced it is building the foundations of a national evaluation system to...
radiation dose in the cath lab
News | Radiation Dose Management| May 02, 2016
May 2, 2016 — Starting at the Society for Cardiovascular Angiography and Interventions (SCAI) 2016 annual meeting May
Feature | Business| April 28, 2016 | Dave Fornell
 
Technology | Stents Peripheral| April 27, 2016
Veniti Inc. announced the first successful treatment with the Vici Verto Venous Stent System of a patient suffering...
Auris Surgical Robotics, acquisition, Hansen Medical
News | Robotic Systems| April 26, 2016
Auris Surgical Robotics Inc. and Hansen Medical Inc. announced that they have signed a definitive merger agreement...
CABG, bypass surgery, heart failure, NHLBI study
News | Cardiovascular Surgery| April 25, 2016
Scientists have found that a greater number of patients with coronary artery disease may benefit from coronary artery...
Siemens Sensis Vibe, hemodyanamics system

Siemens released the Sensis Vibe hemodyanamics system at ACC.16. The newer system offers better integration of cath lab data into cath lab reports and the electronic medical record (EMR).

Feature | ACC| April 25, 2016 | Jon Brubaker, MBA, RCVT, Tom Watson, BS, RCVT, and Sabrina Newell MS, RCS
There were several trends seen in new cardiovascular technologies showcased on the expo floor at the 2016 American...
Medtronic, Drug-Filled Stent, RevElution Trial results, ACC.16, CE Mark
News | Stents Drug Eluting| April 21, 2016
Medtronic plc announced new clinical data from one of the endpoints in the RevElution Trial for its novel, next-...
Boston Scientific, Fetch 2 aspiration catheter, Class 1 recall
News | Thrombectomy Devices| April 20, 2016
April 20, 2016 — Boston Scientific Corp. announced a U.S.
Overlay Init