clinical study to evaluate the device. Following
completion of the study, we collect, analyze, and present the
data in an appropriate submission to the FDA, either a 510(k) or
Under the 510(k) process, the FDA determines
whether or not the device is substantially
equivalent to a predicate device. In making this
determination, the FDA compares both the new device and the
predicate device. If the two devices are comparable in intended
use, safety, and effectiveness, the device may be cleared for
Under the PMA process, the FDA examines detailed
data relating to the safety and effectiveness of the device.
This information includes design, development, manufacture,
labeling, advertising, pre-clinical testing, and clinical study
data. Prior to approving the PMA, the FDA generally will conduct
an inspection of the facilities producing the device and one or
more clinical sites where the study was conducted. The facility
inspection evaluates the companys readiness to
commercially produce and distribute the device. The inspection
includes an evaluation of compliance under the Quality System
Regulation (QSR). Under certain circumstances, the FDA may
convene an advisory panel meeting to seek review of the data
presented in the PMA. If the FDAs evaluation is favorable,
the PMA is approved, and we can market the device in the
U.S. The FDA may approve the PMA with conditions, such as
post-market surveillance requirements.
We evaluate changes made following 510(k)
clearance or PMA approval for significance and if appropriate,
make a subsequent submission to the FDA. In the case of a
significant change being made to a 510(k) device, we submit a
new 510(k). For a PMA device, we will either need approval
through a PMA supplement or will need to notify the FDA.
For our 510(k) devices, we design the submission
to cover multiple models or variations in order to minimize the
number of submissions. For our PMA devices, we rely upon the PMA
approvals of our strategic partners to utilize the PMA
supplement regulatory path rather than pursue an original PMA.
Because of the differences in the amount of data and numbers of
patients in clinical trials, a PMA supplement process is often
much shorter than the amount of time and data required for
approval of an original PMA.
Currently our NIOBE cardiology magnet system,
NAVIGANT advanced user interface, CARDIODRIVE automated catheter
advancer, family of CRONUS coronary guidewires, and TANGENT
electrophysiology mapping catheter have been cleared by the FDA
to be used in interventional procedures. In addition, we have
received the CE Mark for our HELIOS electrophysiology ablation
catheter and, in the U.S., expect to complete clinical trials in
mid-2004 and file for PMA approval in late 2004.
We are subject to risks associated with
U.S. government regulation. See Risk Factors
for a discussion of the specific regulatory risks associated
with our business.
In order for us to market our products in other
countries, we must obtain regulatory approvals and comply with
extensive safety and quality regulations in other countries.
These regulations, including the requirements for approvals or
clearance and the time required for regulatory review, vary from
country to country. Failure to obtain regulatory approval in any
foreign country in which we plan to market our products may harm
our ability to generate revenue and harm our business.
The primary regulatory environment in Europe is
that of the European Union, which consists of 15 countries
encompassing most of the major countries in Europe. The European
Union requires that manufacturers of medical products obtain the
right to affix the CE Mark to their products before selling them
in member countries of the European Union. The CE Mark is an
international symbol of adherence to quality assurance standards
and compliance with applicable European medical device
directives. In order to obtain the right to affix the CE Mark to
products, a manufacturer must obtain certification that its
processes meet certain European quality standards. Compliance
with the Medical Device Directive, as certified by a recognized
European Notified Body, permits the manufacturer to