TAVI: PLC Systems launches RenalGuard trial

September 16, 2013 by Sony Salzman

PLC Systems treats the 1st patient with its RenalGuard in a trial to evaluate the device in patients with acute kidney failure undergoing heart valve replacement procedures.

TAVI: PLC Systems launches RenalGuard trial

PLC Systems (PINK:PLCSF) said its RenalGuard device was used in a new clinical trial evaluating the device in treating patients with acute kidney failure undergoing transcatheter aortic valve implantation.

The TAVI procedure, used in patients with faulty aortic valves, can cause complications including acute kidney failure. PLC hopes to show that patients treated with RenalGuard will suffer less from acute kidney failure than those without the renal treatment.

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Ultimately, the 200 patients in the trial will be randomly selected for either a RenalGuard treatment or a placebo treatment during the TAVI procedure. The company will be carefully monitoring the rate of acute kidney injury at 48-72 hours, the trial's primary endpoint.

"TAVI is one of many in-hospital procedures that can lead to acute kidney injury. This hospital-initiated study will be a major contribution to the science of acute kidney injury in these high-profile TAVI cases," CEO Mark Tauscher said in prepared remarks.

The 1st TAVI procedure using PLC's RenalGuard was performed by Dr. Yaron Arbel at Tel Aviv Sourasky Medical Center in Israel.