FocalCool is creating a new paradigm for emergency angioplasty care. While reperfusion therapy and stents have created paradigm shifts in interventional care, FocalCool aims to create another shift -- directly addressing myocardial reperfusion injury.
CoolGuide Guide Catheter
FocalCool has designed a cooling guide catheter.
CoolGuide not only provides interventional tool access like other guide catheters it also can locally cool tissue at risk of injury during acute myocardial infarctions.
CoolGuide Cooling Console
The Cooling Console circulates chilled saline through CoolGuide.The saline is pumped through the catheter and cooled to the desired temperature.The user controls and monitors the temperature and flow rate of saline delivered to the catheter with a touch screen computer.
Device Testing/Validation
To analyze the performance of each device FocalCool has two mock circulatory loops.
Both mock loops offer pulsatile flow (similar to that of a heart beat), and physiological conditions for testing catheters. These conditions include heart rate, aortic pressure, aortic and coronary flow, and core temperature.
*** The CoolGuide catheter and CoolGuide console are not currently available for sale or investigational use ***
*** The safety and effectiveness of the device has not been established ***
