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Cardium's InnerCool Announces Positive Benefits of Cooling During Robotic-Assisted Prostate Surgery Published in Urology
Date:3/9/2009

and is being utilized in current studies designed to improve the ease of use and provide more cooling power, which may potentially further enhance clinical outcomes. It is believed that additional ongoing studies may offer the potential to demonstrate improved post-operative erectile function for patients as well. A study is underway by Dr. Ahlering and his colleagues at the University of California, Irvine, utilizing the UroCool(TM) system to further evaluate the potential safety and benefits of localized cooling during robotic-assisted prostatectomy, which is now the most common surgical technique for prostate cancer. A regulatory application for FDA 510(k) clearance of InnerCool's UroCool(TM) catheter is expected to be submitted in the first quarter of 2009.

The UroCool(TM) catheter is designed to be placed within the rectal cavity adjacent to the prostate during surgery and is used in conjunction with InnerCool's Celsius Control System(TM) which circulates cold saline in a closed loop within the catheter to allow for localized cooling. Drs. Ahlering and Finley believe that therapeutic cooling of the prostate tissue and surrounding areas during surgery (which includes both traditional open surgical approaches and the newer robotic-assisted prostatectomy) offers the potential to reduce tissue damage and inflammation and thereby provide a faster return of bladder control (continence) and possibly erectile function (potency) following surgery.

"These findings and other research conducted by Dr. Ahlering, one of the nation's experts in the field of robotic-assisted prostate surgery, demonstrating the benefits of cooling during robotic-assisted prostatectomy underscore the potential value of InnerCool's new investigational UroCool(TM) catheter system. We plan to submit a regulatory application for FDA 510(k) clearance for the new UroCool(TM) catheter this month," stated Christopher J. Reinhard, Chairman and Chief Exe
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SOURCE Cardium Therapeutics
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