Initial Case Series with Exalt Single-Use Duodenoscope * Expanded User Experience

Flexible endoscopes are used globally for the diagnosis and treatment of
diseases of the GI tract. These delicate instruments are used in Endoscopic
Retrograde Cholangiopancreatography (ERCP) procedures, which are performed with
side viewing endoscopes (duodenoscopes) that to date are all reusable devices.
Given their reusability, these instruments must be reprocessed through high
level disinfection (HLD) in order to prevent the spread of nosocomial
infections, although different levels of disinfection may be produced depending
on disinfection method, device modification, and staff adherence to
disinfection protocols.

In recent years there have been an increased number of nosocomial infection
outbreaks traced to contaminated duodenoscopes used during ERCP procedures in
many states throughout the US and Europe. Organisms involved in these recent
outbreaks include Carbapenem-resistant Enterobacteriaceae (CRE), including
Escherichia coli, and Klebsiella pneumoniae. Unfortunately, some of the cases
linked to these outbreaks have proven to be fatal. Typically, infections
discovered post-ERCP procedures vary between 2%-4%, but it is unclear whether
these infections are caused by contaminated duodenoscopes or the procedure.

The gastrointestinal tract is a highly contaminated environment, and the
intricate tip design and long, narrow working channels of modern duodenoscopes
render them extremely difficult, if not impossible, to adequately clean. Even
strict adherence to all HLD procedures results in a non-zero, although minimal,
level of potentially infectious microbes. Months after initial reports of
duodenoscope linked infections surfaced in the US, the FDA stated that they
were warning manufacturers, monitoring, and providing closer surveillance in an
effort to prevent further infections associated with contaminated duodenoscopes.

In summary, conventional reusable duodenoscopes have been identified as the
source of multiple cases of fatal and nonfatal nosocomial infections throughout
the US and Europe, despite adherence to duodenoscope sterilization and
reprocessing guidelines. The infectious organisms were later identified as
belonging to a family of bacteria that has a high level of resistance to
conventional antibiotics, known as CRE. To date, there are no single-use
disposable duodenoscopes available in the open market, which do not need to be
sterilized or reprocessed because they are only used for a single patient in
one case before they are disposed of. The availability of such a device may
save patient lives by removing a potential source of infection and save the
healthcare system money used to treat the infections and to reprocess the
devices.

The objective of this study is to confirm procedural performance of the Exalt
single-use duodenoscope in Endoscopic Retrograde Cholangiopancreatography
(ERCP) or other duodenoscope-based procedures.

This is a prospective, multi-center case series of per standard of care ERCP
procedures of up to 200 cases. The endoscopist will use the Exalt single-use
duodenoscope in place of the reusable duodenoscope normally used in the
endoscopy unit at their own discretion.

Subjects will have their clinically indicated ERCP or other duodenoscope-based
procedure performed using the Exalt single-use duodenoscope.

The following potential anticipated adverse events (AE) and anticipated adverse
device effects (ADE) which may be associated with the use of a generic reusable
duodenoscope and type of procedure as well as related to the use of the Exalt
Single-Use Duodenoscope have been identified for this study:
* Perforation
* Bleeding
* Infection
* Tissue damage
* Pain
* Air Embolism
* Burn
* Allergic Reaction
* Electric Shock
Additional risks may exist which are unknown at this time. Risks can be
minimized through compliance with this protocol, performing procedures in the
appropriate hospital environment, adherence to patient selection criteria,
close monitoring of the patient*s physiologic status during research procedures
and/or follow-ups and by promptly supplying the Sponsor with all pertinent
information required by this protocol. Patient risk is further minimized by
placing no restriction on an investigator*s decision to stop using the Exalt
duodenoscope and switch to their standard duodenoscope.
Patients may not receive any benefit from participating in this study. However,
medical science and future patients may benefit from this study. Based on
collected reports in literature to-date, the risk-to-benefit ratio is within
reason for foreseeable risks. However, literature reports do not always capture
all side effects. Observation and follow-up of patients is required as outlined
in the protocol.