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

University of Utah, Frank Sachse, heart failure, LVAD implantation, left ventricular assist device, biomarker, t-system

Two patients may seem equally sick based upon clinical measures, but differences in their heart physiology could predict who has the potential to recover from heart failure. A study carried out by scientists at the University of Utah finds that patients whose hearts have flattened t-tubules have a decreased chance of showing signs of recovery after implanting a mechanical heart pump. Ordinarily, t-tubules in the heart are long, thin, and rounded. Image courtesy of Frank Sachse.

News | Cardiac Diagnostics| January 17, 2017
Investigators at the University of Utah have identified distinct differences in the hearts of advanced heart failure...
Synergy stent, abluminal polymer DES, bioresorbable polymer DES, bioresorbable polymer metallic stent

The Synergy stent is the first FDA cleared drug-eluting stent to use a bioresorbable polymer drug carrier. When the polymer dissolves after about four months, the devices become a bare metal stent. The technology is supposed to reduce the rate of late stent thrombosis due to vessel inflammation caused by durable polymers.

Feature | Stents Bioresorbable| January 17, 2017 | Dave Fornell
One of the big advancements in drug-eluting stent (DES) technology has been the development of bioresorbable polymers
Medtronic, CoreValve Evolut R TAVR system, U.S. IDE Study, TCT 2016
News | Heart Valve Technology| November 03, 2016
Medtronic plc unveiled new clinical data showing that patients treated with the self-expanding CoreValve Evolut R...
congenital heart patients, cardiac cath lab, anesthesia sedation practices, joint document, SCAI, SPA, CCAS
News | Congenital Heart| November 03, 2016
The Society for Cardiovascular Angiography and Interventions (SCAI), the Society for Pediatric Anesthesia (SPA) and the...
open-heart surgery, PCI, percutaneous coronary intervention, NOBLE trial, left main coronary artery disease, LMCAD, TCT 2016
News | Cardiovascular Surgery| November 03, 2016
Coronary artery bypass (CABG) surgery is the standard treatment for revascularization in patients with left main...
SENTINEL trial, transcatheter embolic protection, TCEP, TAVR, stroke, TCT 2016
News | Embolic Protection Devices| November 03, 2016
An international study has found that transcatheter cerebral embolic protection (TCEP) is safe, provides effective...
News | Drug-Eluting Balloons| November 03, 2016
The Spectranetics Corp. announced that it has submitted to the U.S. Food & Drug Administration (FDA) its Pre-Market...
RESPECT trial, Amplatzer PFO Occluder, St. Jude Medical, TCT 2016
News | Structural Heart Occluders| November 02, 2016
St. Jude Medical Inc. announced the long-term data from RESPECT, a landmark trial, during a First Report session at the...
Medtronic, Resolute Integrity DES, drug-eluting stent, BIO-RESORT study, TCT 2016
News | Stents Drug Eluting| November 02, 2016
Investigators recently unveiled clinical data from the independent BIO-RESORT study, representing the first all-comers...
Medtronic, Harmony TPV, transcatheter pulmonary valve, clinical study results, TCT 2016
News | Heart Valve Technology| November 02, 2016
Medtronic plc recently announced new clinical data for the Harmony Transcatheter Pulmonary Valve (TPV) from its early...
Overlay Init