Dr. Ron Waksman to Discuss Details of First US Coronary Remote Control Catheterization Trial (CORRECT) at TCT 2006
Posted on: Wednesday, 25 October 2006, 09:01 CDT
Corindus, developer and marketer of proprietary remote control catheterization systems, announced today that it filed its Investigational Device Exemption (IDE) application for the CORRECT (Coronary Remote Control Catheterization Trial) clinical trial at the Cardiovascular Research Foundation's eighteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.
"We have filed our IDE and have begun to train the CORRECT Investigators on the CorPathTM system" said Tal Wenderow, Corindus' CEO. Corindus expects to begin the CORRECT trial shortly after TCT.
Dr. Ron Waksman of the Cardiovascular Research Institute in Washington D.C. will discuss the CORRECT clinical trial and present data on the CorPathTM remote control catheterization system on Thursday, October 26th at 1:02 PM during the sessions on Navigation, Telemanipulation, Robotics, and Sensor-Based Guidance.
Dr. Waksman will be the Principal Investigator for the CORRECT clinical trial, which will be carried-out at six sites in the United States and Europe and will enroll up to 100 patients. "CorPathTM is a step forward in angioplasty," Dr. Waksman said. "The system should help reduce the cumulative effects of daily exposure to harmful X-ray radiation and the need for standing long periods of time while wearing leaded protective garments. I look forward to beginning the U.S. trial."
Barring any setbacks, Corindus anticipates completing the CORRECT trial in the first half of 2007 and receiving FDA clearance for CorPathTM late next year.
About Corindus
Corindus designs, manufactures and commercializes patented remote control systems for interventional cardiology. Its CorPathTM system enables the physician to perform catheterization procedures from a remote location beyond the radiation zone. Compatible with state-of-the-art cardiology products and cath lab imaging technologies, CorPathTM mechanically maneuvers devices through patients' arteries as specified by the physician at a remote workstation. The proprietary technology utilizes physician fluoroscopic control similar to routine practice to allow maneuvering and torquing of cath lab devices. Initial clinical trials have demonstrated CorPath's safety and efficacy. Unique to CorPathTM is the simplicity of integration into existing cath lab systems.
The CorPath™ system requires regulatory clearance and currently is used for investigational purposes only.
Source: Business Wire
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