Regulatory Focus™ > News Articles > FDA Plans Huge Cardiovascular Registry With Focus on Medical Devices

FDA Plans Huge Cardiovascular Registry With Focus on Medical Devices

Posted 02 April 2013 | By Alexander Gaffney, RAC

The use of registries-patient and otherwise-in regulatory circles is something of a recent and surging phenomenon.  If regulators can get a better sense of the data behind some of the toughest or most common diseases, the theory goes, then they can tailor their expectations for clinical trials and in some cases accept surrogate endpoints as evidence of safety or efficacy. That has the potential to save sponsors both time and money, and get products to patients more quickly.

Now the US Food and Drug Administration (FDA) is increasing its stake in registries in a big way, calling for the development of an international consortium of cardiovascular registries that would serve to coordinate data from various disease registries in order to test the efficacy and safety of medical devices. 


Registries have been used to great regulatory success in recent years. Perhaps the most iconic example is that of the Cystic Fibrosis Foundation's patient registry, used to help tests dozens of products and used to help support the landmark approval of Kalydeco (ivacaftor) for the treatment of cystic fibrosis.

Subsequent to that approval, more pharmaceutical companies are expressing interest in registries. Sanofi, for example, has since given more than $300,000 to a patient registry group called Registries for All Diseases (Reg4All), which aims to create a cross-disease registry for hundreds, if not thousands of diseases.

The government's interest in these registries seems to be growing as well, with the Association of Healthcare Research and Quality (AHRQ) announcing in 2012 that it would be establishing a registry of patient registries to keep track of their burgeoning numbers and to hopefully reduce the amount of duplication.

FDA, too, has used registries for its own purposes before. In 2012, it announced the establishment of a registry to assess the potentially fatal risks of imaging contrast agents.

Cardiovascular Registry

But the international cardiovascular registry would be a massive step up from any registry maintained by FDA, and perhaps any other group. At present, the largest disease registries tend to focus on either a single disease or a single geographic region-not several related diseases across the globe. FDA said the project is modeled on the International Consortium of Orthopedic Registries (ICOR), which maintains a similar framework for linking up member registries.

But cardiovascular procedures are more widely practiced than orthopedic ones, making its potential impact far greater, FDA said.

"Cardiovascular procedures are performed in hundreds of thousands of patients every year to treat all manner of cardiovascular disease from coronary artery disease to peripheral vascular disease, intracardiac ablation to surgical interventions, implant of stents to implants of pacemakers, defibrillators, and their associated leads," FDA explained.

To regulators, the problem is now that the data obtained by various global registries and trials are segmented and unable to be shared with others. In the case of clinical trials, information is limited due to their "small size, short follow-up and lack of generalizability," FDA explained. In the case of long-term observational studies, the registries can be limited in their size and scope (often a particular country, region or healthcare system).

First Focus: TAVR

What FDA wants to do, then, is break down barriers and create a "comprehensive understanding" of not only cardiovascular disease, but the medical devices that treat them as well. This, it said, will require the incorporation of data obtained not just in the US, but around the world as well.

If successfully developed, the registry would serve to "allow for broad-based analysis and surveillance of medical device exposure and related clinical outcomes."

This proposed system is still very much in the formative stages of development, however. FDA said it soon plans to hold a workshop to solicit public input on the plan, including the identification of specific issues and a "roadmap" for implementing the plan.

Regulators added that the registry approach would be phased in, with the first investigation targeting transcatheter valve therapy devices and procedures.

The meeting will be held on 22 April 2013 at FDA's White Oak, MD campus.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.