MEDICAL DEVICE INNOVATION - Medical Device Daily

108
PLC Systems to unveil results
from MYTHOS clinical trial
By OMAR FORD
Medical Device Daily Staff Writer
PLC Medical Systems (Franklin, Massachusetts)
reported that the initial abstract results from a clinical
study evaluating the effectiveness of its RenalGuard
System have been published. The company said that the
investigator-sponsored clinical study has also been published
on the European Society of Cardiology (Sophia
Antipolis, France) web site in advance of that society’s
annual meeting Aug. 29 – Sept. 2, 2009 in Barcelona, Spain.
The CCM trial, known as MYTHOS, is a randomized clinical
trial designed to provide an assessment of the potential
benefits of induced diuresis with automated matched
hydration therapy utilizing RenalGuard, compared to standard
overnight hydration, a prevalent method of treatment
in the EU, in the reducing the incidence of contrast-induced
nephropathy (CIN) in patients undergoing cardiac catheterization
procedures and percutaneous coronary interventions
with baseline impairment in renal function. The study
is designed as a non-inferiority trial, with the primary endpoint
defined as equivalency or better to overnight hydration.
“What the investigators are attempting to show is that
the RenalGuard is just as good if not better than any of the
rehydration therapies available out there,” president/CEO
Mark Tauscher told Medical Device Daily. “RenalGuard
works in the same amount of time as a cardiac catheterization
and is used continually up until a patient checks into
the cath lab.”
The system is designed to reduce the toxic effects that
contrast media can have on the kidneys when it is administered
to patients during certain medical imaging procedures.
It does this by inducing and maintaining a high urine
flow rate before, during and after these medical imaging
procedures. It is believed that allowing contrast media to
dwell in the kidneys can lead to CIN, a potentially deadly
form of acute kidney injury.
RenalGuard includes a console and a RenalGuard Single
Use Set for infusion and urine collection. The Single Use Set
contains a urine collection set which connects to a patient’s
Foley catheter and an infusion set which connects to a standard
IV catheter. The console measures the volume of urine
in the collection set and infuses an equal volume of hydration
fluid to match the patient’s urine output.
The console relies on proprietary software and electronic
weight measurements to control the rate at which
fluid is infused and to monitor urine volume.
The console is mounted on a standard IV pole and is
equipped with an internal battery that allows operation
while the patient is being transported within a hospital.
Tauscher added that it eliminates the need for patients
MEDICAL DEVICE INNOVATION 2010
to come in over night and be hydrated – a procedure that’s
costly in time and money to the patient and care providers.
The preliminary results provided by the company on
the clinical study delve into details on 43 patients at high
risk for renal failure. The final study is expected to include
nearly 120 patients. The initial results indicate that none of
the patients treated with RenalGuard while undergoing
imaging procedures acquired CIN, but 17% of those who
were treated beforehand with overnight hydration did
acquire CIN.
The results go on to show that two of the patients in
that group required temporary renal replacement therapy.
Acquiring CIN has been found to lead to a range of serious
and potentially deadly outcomes in patients who already
have compromised kidney function.
PLC first received the CE mark for the RenalGuard
System in December 2007, and concluded its pilot safety
trial in the U.S. late in 2007. In March 2008, PLC signed its
first international distribution agreement for RenalGuard
with Artech (Cavezzo, Italy) for distribution of its
RenalGuard System into Italy. Nearly a year later the company
reported gaining a second European distributor, Izasa
Distribuciones Tecnicas (Barcelona, Spain), for the distribution
of RenalGuard in Spain.
The company has received full approval from the FDA
to commence a U.S. pivotal trial to study the effectiveness
of RenalGuard in reducing the incidence of CIN.
The company previously put plans on hold for the
device after the market dropped in 2007.
“When the stock market collapsed we didn’t think we
could raise any more money,” Tauscher said. “We’re hoping
this data will be instrumental in helping us raising funds in
the U.S. and that investors will see that this device has
strong data and that they can invest in it. We’re also hoping
this data will drive more sales in Europe.”
(This story originally appeared in the Aug. 26, 2009,
edition of Medical Device Daily)
To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547.
Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.