Medical Device Daily

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 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 (Medical Device Daily, March 31, 2008). 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."

Omar Ford, 404-262-5546; omar.ford@ahcmedia.com