Feature | January 23, 2014
FDA Premarket Approval PMA Clinical Study EP Lab Cath Leads Implantable Devices

St. Jude Medical Riata

January 23, — The U.S. Food and Drug Administration (FDA) has approved many cardiac implantable electronic device models currently in use through a review process in which models were deemed safe and effective based on approval of prior versions of the device, according to a study published in JAMA.
 
The premarket approval (PMA) process used by the FDA has attracted attention in recent years after recall of device components that were not tested clinically in human trials prior to approval because they were design changes to prior-marketed devices, and considered supplements to previously submitted PMA applications. Examples cited in the report include leads from Medtronic Sprint Fidelis and St. Jude Medical Riata implantable cardioverter-defibrillators (ICDs).
 
PMA supplemental approval "allow[s] patients to benefit from incremental innovation in device technology by providing efficient and inexpensive FDA review pathways for smaller device changes. Supplements may include major or minor design changes as well as routine changes in labeling, materials or packaging. By statute, the FDA must seek only the 'least burdensome' supporting data necessary for review."
 
Benjamin N. Rome, B.A., of Harvard Medical School and Brigham and Women's Hospital, Boston, and colleagues used the FDA's PMA database to review CIEDs (including pacemakers, ICDs, and cardiac resynchronization therapy [CRT] devices) approved as PMA supplements from 1979 through 2012. They identified the number of supplements to each original PMA and characterized the nature of the changes in each supplement.
 
77 approved PMA applications for CIEDs (46 pacemaker devices, 19 ICDs, and 12 CRT devices) were the basis for 5,829 PMA supplement applications, with a median of 50 supplements per original PMA. In the last decade, the number of approved supplements annually increased to 704. Excluding manufacturing changes that do not alter device design, the number of supplements approved each year averaged 2.6 per PMA per year.
 
37 percent of supplements represented at least minor alterations to the device's design or materials. Among 180-day supplements (a type of FDA review process) approved between 2010 and 2012, 23 percent included new clinical data to support safety and effectiveness.
 
"Our results should not be interpreted to indicate that the FDA is failing to review PMA supplement applications to determine safety and effectiveness," the authors reported. “However, clinicians and patients should … be aware … that clinical data are rarely collected as part of PMA supplement applications prior to marketing.”
 
For more information: jamanetwork.com

Related Content

Hansen Medical, Magellan 10 French Robotic Catheter, FDA 510(k) clearance
Technology | July 29, 2015
The Magellan 10 French Robotic Catheter from Hansen Medical is indicated for use in the peripheral vasculature.
Itrevia 7 HF-T QP, Biotronik, CRT-D, first U.S. implantations, CLS algorithm
Feature | Cardiac Resynchronization Therapy Devices (CRT)| July 28, 2015
Biotronik announced the first patients have been successfully implanted with Itrevia HF-T QP cardiac resynchronization...
Products | Guidewires| July 28, 2015
The Safari2 Pre-Shaped Guidewire.
CSI, ViperWire Advance Peripheral Guide Wire with Flex Tip, Stealth, Diamondback

Diamondback 360 Peripheral OAS image courtesy of Cardiovascular Systems Inc.

Technology | July 22, 2015
Cardiovascular Systems Inc. announced that it has received U.S. Food and Drug Administration (FDA) clearance for its...
The Medicines Company, bivalirudin, Angiomax, litigation, Hospira Inc.
News | Cath Lab| July 22, 2015
The Medicines Company announced the U.S. Court of Appeals for the Federal Circuit Court has ruled against the company...
Feature | Atrial Fibrillation| July 20, 2015
A new study proves race and gender-related disparities exist in care for patients who have recently been diagnosed with...
Boston Scientific, fully absorbable scaffold, FAST study, resorbable
Feature | Stents Bioresorbable| July 20, 2015
Boston Scientific has initiated a study of the company's first fully resorbable drug-eluting scaffold system. The Fully...
Veryan Medical, BioMimics 3D femoropopliteal stent, MIMICS-2 study, PAD
News | Stents Peripheral| July 17, 2015
Veryan Medical announced that the first subject has been enrolled in their MIMICS-2 study at Universitäts-Herzzentrum...
Overlay Init